Trial Outcomes & Findings for Falls Prevention Program for Adults With Osteoarthritis (NCT NCT02648646)
NCT ID: NCT02648646
Last Updated: 2018-10-26
Results Overview
Number of participants who adhere to the intervention.
COMPLETED
NA
10 participants
6 months
2018-10-26
Participant Flow
Participant milestones
| Measure |
Single Arm - Intervention
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Falls Prevention Program for Adults With Osteoarthritis
Baseline characteristics by cohort
| Measure |
Single Arm - Intervention
n=10 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=39 Participants
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Age, Categorical
>=65 years
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10 Participants
n=39 Participants
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Age, Continuous
|
71.3 years
n=39 Participants
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|
Sex: Female, Male
Female
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8 Participants
n=39 Participants
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Sex: Female, Male
Male
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2 Participants
n=39 Participants
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Region of Enrollment
United States
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10 participants
n=39 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: 8 participants completed the 6-month intervention
Number of participants who adhere to the intervention.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Participant Adherence to Intervention
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5 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: 8 participants completed the 6-month intervention
Number and type of adverse events related to the intervention.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Participant Safety With the Intervention
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0 adverse events
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PRIMARY outcome
Timeframe: 6 monthsNumber of participants who participate in the study for the full 6 month program.
Outcome measures
| Measure |
Single Arm - Intervention
n=10 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Retention of Participants
Completed
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8 Participants
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Retention of Participants
Reason not completed: total knee replacement
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1 Participants
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Retention of Participants
Reason not compelted: Injury not related to study
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1 Participants
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PRIMARY outcome
Timeframe: 6 monthsDescriptive summary of participants' reports from closing interview of what they like and do not like about the program, any challenges they experienced with doing the program, and whether they plan to continue what they learned.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Acceptability of the Program
Liked exercising with this program
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2 Participants
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Acceptability of the Program
The program helped individual move better
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3 Participants
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Acceptability of the Program
Exercises were easy
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1 Participants
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Acceptability of the Program
Liked the program gave structure
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1 Participants
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Acceptability of the Program
Liked that program promoted working towards goals
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1 Participants
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Acceptability of the Program
Did not like Walk With Ease workbook, hard to use
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1 Participants
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Acceptability of the Program
One exercise hurt hip; PT changed it & was fin
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1 Participants
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Acceptability of the Program
Reported no dislikes of program
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6 Participants
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Acceptability of the Program
Challenge of program: standing on 1 foot
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3 Participants
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Acceptability of the Program
Challenge of program: needed to hold onto counter
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1 Participants
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Acceptability of the Program
Exercises were challenging at first
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1 Participants
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Acceptability of the Program
Challenging to learn new exercises
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1 Participants
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Acceptability of the Program
Challenge to make self do program on own
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1 Participants
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Acceptability of the Program
No challenges with program
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1 Participants
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Acceptability of the Program
Plans to continue to practice what they learned
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8 Participants
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SECONDARY outcome
Timeframe: Baseline to Month 6Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Number of Falls
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3 falls
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SECONDARY outcome
Timeframe: Baseline to Month 6Participant will record whether the fall resulted in an injury and the type of injury that occurred. A fall will be considered severe if an injury occurred.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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Number of People With Severe of Falls
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1 Participants
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SECONDARY outcome
Timeframe: BaselineThis is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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Berg Balance Scale
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47.5 units on a scale
Interval 39.0 to 52.0
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SECONDARY outcome
Timeframe: BaselineFour timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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Four-tests Balance: Feet Together Stand
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10 seconds
Interval 0.0 to 10.0
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SECONDARY outcome
Timeframe: BaselineParticipant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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Hand Grip Dynamometry Right Hand
|
15.7 kilograms
Interval 9.3 to 26.7
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SECONDARY outcome
Timeframe: BaselineParticipant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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30-second Chair Stand Test
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9 completed maneuvers
Interval 6.0 to 14.0
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SECONDARY outcome
Timeframe: BaselineParticipant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Timed Up and Go Test
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21.6 seconds
Interval 12.2 to 27.3
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SECONDARY outcome
Timeframe: BaselineParticipant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Stair Climb Test
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9.8 seconds
Interval 6.5 to 15.9
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SECONDARY outcome
Timeframe: BaselineThis questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index
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37 units on a scale
Interval 15.0 to 46.0
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SECONDARY outcome
Timeframe: BaselineParticipant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Activities-specific Balance Confidence Scale
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64.1 percentage of confidence
Interval 25.0 to 78.8
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SECONDARY outcome
Timeframe: BaselineParticipants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: 1. I rarely or never do any physical activities. Under-active: 2. I do some light or moderate physical activities, but not every week. Under-active regular - light activities: 3. I do some light physical activity every week. Under-active regular: 4. I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. 5. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: 6. I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. 7. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Rapid Assessment of Physical Activity: Aerobic Score
|
3.5 units on a scale
Interval 2.0 to 7.0
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SECONDARY outcome
Timeframe: Week 8This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Berg Balance Scale
|
49.5 units on a scale
Interval 44.0 to 53.0
|
SECONDARY outcome
Timeframe: Month 6This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Berg Balance Scale
|
48 units on a scale
Interval 43.0 to 56.0
|
SECONDARY outcome
Timeframe: Week 8Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Four-tests Balance: Feet Together Stand
|
10.0 seconds
Interval 2.3 to 10.0
|
SECONDARY outcome
Timeframe: Month 6Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
|
Four-tests Balance: Feet Together Stand
|
10.0 seconds
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: BaselineFour timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Four-tests Balance: Semi-tandem Stand
|
10.0 seconds
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 8Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
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Four-tests Balance: Semi-tandem Stand
|
7.4 seconds
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Month 6Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Four-tests Balance: Semi-tandem Stand
|
10.0 seconds
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: BaselineFour timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
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|---|---|
|
Four-tests Balance: Tandem Stand
|
10.0 seconds
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Week 8Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Four-tests Balance: Tandem Stand
|
0.0 seconds
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Month 6Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Four-tests Balance: Tandem Stand
|
5.2 seconds
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: BaselineFour timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Four-tests Balance: One Leg Stand
|
0.0 seconds
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Week 8Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Four-tests Balance: One Leg Stand
|
0.0 seconds
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Month 6Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Four-tests Balance: One Leg Stand
|
0.9 seconds
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: Week 8Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Hand Grip Dynamometry Right Hand
|
15.0 kilograms
Interval 10.7 to 28.0
|
SECONDARY outcome
Timeframe: Month 6Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Hand Grip Dynamometry Right Hand
|
17.7 kilograms
Interval 14.7 to 24.7
|
SECONDARY outcome
Timeframe: BaselineParticipant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Hand Grip Dynamometry Left Hand
|
17.0 kilograms
Interval 10.7 to 24.0
|
SECONDARY outcome
Timeframe: Week 8Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Hand Grip Dynamometry Left Hand
|
16.7 kilograms
Interval 7.3 to 26.7
|
SECONDARY outcome
Timeframe: Month 6Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Hand Grip Dynamometry Left Hand
|
16.7 kilograms
Interval 10.0 to 24.7
|
SECONDARY outcome
Timeframe: Week 8Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
30-second Chair Stand Test
|
7.5 completed maneuvers
Interval 6.0 to 16.0
|
SECONDARY outcome
Timeframe: Month 6Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
30-second Chair Stand Test
|
9 completed maneuvers
Interval 8.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 8Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Timed Up and Go Test
|
19.5 seconds
Interval 14.5 to 28.8
|
SECONDARY outcome
Timeframe: Month 6Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Timed Up and Go Test
|
16.8 seconds
Interval 14.5 to 29.5
|
SECONDARY outcome
Timeframe: Week 8Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Stair Climb Test
|
9.0 seconds
Interval 7.1 to 17.5
|
SECONDARY outcome
Timeframe: Month 6Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Stair Climb Test
|
8.8 seconds
Interval 5.3 to 16.9
|
SECONDARY outcome
Timeframe: Week 8This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
Outcome measures
| Measure |
Single Arm - Intervention
n=7 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index
|
31 units on a scale
Interval 9.0 to 52.0
|
SECONDARY outcome
Timeframe: Month 6This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index
|
23.5 units on a scale
Interval 16.0 to 41.0
|
SECONDARY outcome
Timeframe: Week 8Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Activities-specific Balance Confidence Scale
|
60.6 percentage of confidence
Interval 51.9 to 80.6
|
SECONDARY outcome
Timeframe: Month 6Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Activities-specific Balance Confidence Scale
|
59.1 percentage of confidence
Interval 31.3 to 81.3
|
SECONDARY outcome
Timeframe: Week 8Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: 1. I rarely or never do any physical activities. Under-active: 2. I do some light or moderate physical activities, but not every week. Under-active regular - light activities: 3. I do some light physical activity every week. Under-active regular: 4. I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. 5. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: 6. I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. 7. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Rapid Assessment of Physical Activity: Aerobic Score
|
4 units on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Month 6Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: 1. I rarely or never do any physical activities. Under-active: 2. I do some light or moderate physical activities, but not every week. Under-active regular - light activities: 3. I do some light physical activity every week. Under-active regular: 4. I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. 5. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: 6. I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. 7. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
Outcome measures
| Measure |
Single Arm - Intervention
n=8 Participants
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Rapid Assessment of Physical Activity: Aerobic Score
|
4 units on a scale
Interval 3.0 to 6.0
|
Adverse Events
Single Arm - Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm - Intervention
n=10 participants at risk
Receives Otago Exercise Programme and Walk with Ease
Otago Exercise Programme and Walk with Ease: The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Injury
|
10.0%
1/10 • Number of events 1 • 6 months
|
Additional Information
Yvonne Golightly PT, PhD, Assistant Professor of Epidemiology
University of North Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place