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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 months

Results posted on

2018-10-26

Participant Flow

Participant milestones

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.
Overall Study
STARTED
10
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Falls Prevention Program for Adults With Osteoarthritis

Baseline characteristics by cohort

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.
Age, Categorical
<=18 years
0 Participants
n=39 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=39 Participants
Age, Categorical
>=65 years
10 Participants
n=39 Participants
Age, Continuous
71.3 years
n=39 Participants
Sex: Female, Male
Female
8 Participants
n=39 Participants
Sex: Female, Male
Male
2 Participants
n=39 Participants
Region of Enrollment
United States
10 participants
n=39 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 8 participants completed the 6-month intervention

Number of participants who adhere to the intervention.

Outcome measures

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.
Participant Adherence to Intervention
5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 8 participants completed the 6-month intervention

Number and type of adverse events related to the intervention.

Outcome measures

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.
Participant Safety With the Intervention
0 adverse events

PRIMARY outcome

Timeframe: 6 months

Number of participants who participate in the study for the full 6 month program.

Outcome measures

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.
Retention of Participants
Completed
8 Participants
Retention of Participants
Reason not completed: total knee replacement
1 Participants
Retention of Participants
Reason not compelted: Injury not related to study
1 Participants

PRIMARY outcome

Timeframe: 6 months

Descriptive 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

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.
Acceptability of the Program
Liked exercising with this program
2 Participants
Acceptability of the Program
The program helped individual move better
3 Participants
Acceptability of the Program
Exercises were easy
1 Participants
Acceptability of the Program
Liked the program gave structure
1 Participants
Acceptability of the Program
Liked that program promoted working towards goals
1 Participants
Acceptability of the Program
Did not like Walk With Ease workbook, hard to use
1 Participants
Acceptability of the Program
One exercise hurt hip; PT changed it & was fin
1 Participants
Acceptability of the Program
Reported no dislikes of program
6 Participants
Acceptability of the Program
Challenge of program: standing on 1 foot
3 Participants
Acceptability of the Program
Challenge of program: needed to hold onto counter
1 Participants
Acceptability of the Program
Exercises were challenging at first
1 Participants
Acceptability of the Program
Challenging to learn new exercises
1 Participants
Acceptability of the Program
Challenge to make self do program on own
1 Participants
Acceptability of the Program
No challenges with program
1 Participants
Acceptability of the Program
Plans to continue to practice what they learned
8 Participants

SECONDARY outcome

Timeframe: Baseline to Month 6

Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.

Outcome measures

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.
Number of Falls
3 falls

SECONDARY outcome

Timeframe: Baseline to Month 6

Participant 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

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.
Number of People With Severe of Falls
1 Participants

SECONDARY outcome

Timeframe: Baseline

This 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

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.
Berg Balance Scale
47.5 units on a scale
Interval 39.0 to 52.0

SECONDARY outcome

Timeframe: Baseline

Four 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

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: Feet Together Stand
10 seconds
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Baseline

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

Outcome measures

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
15.7 kilograms
Interval 9.3 to 26.7

SECONDARY outcome

Timeframe: Baseline

Participant 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

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 6.0 to 14.0

SECONDARY outcome

Timeframe: Baseline

Participant 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

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
21.6 seconds
Interval 12.2 to 27.3

SECONDARY outcome

Timeframe: Baseline

Participant 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

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
9.8 seconds
Interval 6.5 to 15.9

SECONDARY outcome

Timeframe: Baseline

This 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

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
37 units on a scale
Interval 15.0 to 46.0

SECONDARY outcome

Timeframe: Baseline

Participant 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

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
64.1 percentage of confidence
Interval 25.0 to 78.8

SECONDARY outcome

Timeframe: Baseline

Participants 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

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
3.5 units on a scale
Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: Week 8

This 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

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.
Berg Balance Scale
49.5 units on a scale
Interval 44.0 to 53.0

SECONDARY outcome

Timeframe: Month 6

This 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

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.
Berg Balance Scale
48 units on a scale
Interval 43.0 to 56.0

SECONDARY outcome

Timeframe: Week 8

Four 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

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: Feet Together Stand
10.0 seconds
Interval 2.3 to 10.0

SECONDARY outcome

Timeframe: Month 6

Four 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

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: Feet Together Stand
10.0 seconds
Interval 10.0 to 10.0

SECONDARY outcome

Timeframe: Baseline

Four 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

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 0.0 to 10.0

SECONDARY outcome

Timeframe: Week 8

Four 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

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
7.4 seconds
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Month 6

Four 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

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: Baseline

Four 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

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
10.0 seconds
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Week 8

Four 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

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 6

Four 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

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: Baseline

Four 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

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 8

Four 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

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 6

Four 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

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 8

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

Outcome measures

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 6

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

Outcome measures

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: Baseline

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

Outcome measures

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 8

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

Outcome measures

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 6

Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.

Outcome measures

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 8

Participant 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

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 6

Participant 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

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 8

Participant 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

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 6

Participant 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

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 8

Participant 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

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 6

Participant 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

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 8

This 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

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 6

This 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

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 8

Participant 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

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 6

Participant 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

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 8

Participants 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

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 6

Participants 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

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 events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 919-966-0566

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place