Trial Outcomes & Findings for Fit and Strong! Plus Comparative Effectiveness Trial (NCT NCT03180008)
NCT ID: NCT03180008
Last Updated: 2024-04-19
Results Overview
The Healthy Eating Index 2010 (HEI-2010) measures diet quality based on the Dietary Guidelines for Americans. HEI-2010 total scores range from 0 to 100 points, with a higher score signifying superior diet quality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
413 participants
Primary outcome timeframe
2, 6, 12, and 18 months
Results posted on
2024-04-19
Participant Flow
Participant milestones
| Measure |
Fit and Strong!
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Overall Study
STARTED
|
210
|
203
|
|
Overall Study
2-Month Follow-up
|
192
|
191
|
|
Overall Study
6-Month Follow-up
|
173
|
175
|
|
Overall Study
12-Month Follow-up
|
169
|
156
|
|
Overall Study
COMPLETED
|
182
|
174
|
|
Overall Study
NOT COMPLETED
|
28
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fit and Strong! Plus Comparative Effectiveness Trial
Baseline characteristics by cohort
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 Years
STANDARD_DEVIATION 6 • n=99 Participants
|
68 Years
STANDARD_DEVIATION 6 • n=107 Participants
|
68 Years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
355 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=99 Participants
|
195 Participants
n=107 Participants
|
397 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
193 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
380 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
210 participants
n=99 Participants
|
203 participants
n=107 Participants
|
413 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
The Healthy Eating Index 2010 (HEI-2010) measures diet quality based on the Dietary Guidelines for Americans. HEI-2010 total scores range from 0 to 100 points, with a higher score signifying superior diet quality.
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Dietary Intake
2-Month Follow-up
|
2.1 score on a scale
Standard Error 0.7
|
4.7 score on a scale
Standard Error 0.7
|
|
Dietary Intake
6-Month Follow-up
|
0.8 score on a scale
Standard Error 0.7
|
2.0 score on a scale
Standard Error 0.7
|
|
Dietary Intake
12-Month Follow-up
|
1.3 score on a scale
Standard Error 0.7
|
0.6 score on a scale
Standard Error 0.7
|
|
Dietary Intake
18-Month Follow-up
|
0.0 score on a scale
Standard Error 0.7
|
1.0 score on a scale
Standard Error 0.7
|
PRIMARY outcome
Timeframe: 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Body Weight
2-Month Follow-up
|
-0.5 Kilograms
Standard Error 0.2
|
-2.0 Kilograms
Standard Error 0.2
|
|
Body Weight
6-Month Follow-up
|
-0.8 Kilograms
Standard Error 0.3
|
-2.0 Kilograms
Standard Error 0.3
|
|
Body Weight
12-Month Follow-up
|
-0.9 Kilograms
Standard Error 0.3
|
-1.7 Kilograms
Standard Error 0.3
|
|
Body Weight
18-Month Follow-up
|
-0.9 Kilograms
Standard Error 0.3
|
-1.3 Kilograms
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
A change in Physical activity was assessed using the Physical Activity Scale for the Elderly (PASE). Scored on a scale of 0 - 400, a higher score indicates greater PA.
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Physical Activity Engagement
2 months
|
14.1 score on a scale
Standard Error 4.7
|
29.1 score on a scale
Standard Error 4.8
|
|
Physical Activity Engagement
6 months
|
15.4 score on a scale
Standard Error 5.0
|
17.5 score on a scale
Standard Error 5.0
|
|
Physical Activity Engagement
12 months
|
7.0 score on a scale
Standard Error 4.8
|
11.6 score on a scale
Standard Error 4.9
|
|
Physical Activity Engagement
18 months
|
5.2 score on a scale
Standard Error 4.8
|
12.2 score on a scale
Standard Error 4.9
|
SECONDARY outcome
Timeframe: Baseline, 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
A change in Osteoarthritis "lower extremity pain" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Pain (5 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0-20.
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Lower Extremity Pain
2-Month Follow
|
-0.5 Score on a scale
Standard Error 0.2
|
-1.4 Score on a scale
Standard Error 0.2
|
|
Lower Extremity Pain
6-Month
|
-0.6 Score on a scale
Standard Error 0.3
|
-1.5 Score on a scale
Standard Error 0.3
|
|
Lower Extremity Pain
12-Month
|
-0.7 Score on a scale
Standard Error 0.3
|
-0.9 Score on a scale
Standard Error 0.3
|
|
Lower Extremity Pain
18-Month
|
-0.1 Score on a scale
Standard Error 0.3
|
-0.9 Score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
A change in Osteoarthritis "lower extremity stiffness" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Stiffness (2 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0 to 8.
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Lower Extremity Stiffness
2-Month
|
-0.3 score on a scale
Standard Error 0.1
|
-0.6 score on a scale
Standard Error 0.1
|
|
Lower Extremity Stiffness
6-Month
|
-0.5 score on a scale
Standard Error 0.1
|
-0.5 score on a scale
Standard Error 0.1
|
|
Lower Extremity Stiffness
12-Month
|
-0.6 score on a scale
Standard Error 0.1
|
-0.5 score on a scale
Standard Error 0.1
|
|
Lower Extremity Stiffness
18-Month
|
-0.6 score on a scale
Standard Error 0.1
|
-0.4 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
A change in Osteoarthritis "lower extremity physical function" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Lower extremity physical function (17 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0 to 68.
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Lower Extremity Physical Function
2-Month
|
-1.9 score on a scale
Standard Error 0.7
|
-5.5 score on a scale
Standard Error 0.8
|
|
Lower Extremity Physical Function
6-Month
|
-1.7 score on a scale
Standard Error 0.9
|
-4.9 score on a scale
Standard Error 0.9
|
|
Lower Extremity Physical Function
12-Month
|
-2.0 score on a scale
Standard Error 0.9
|
-4.1 score on a scale
Standard Error 0.9
|
|
Lower Extremity Physical Function
18-Month
|
-2.6 score on a scale
Standard Error 0.9
|
-3.5 score on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline, 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
A change in Lower Extremity Muscle Strength was measured by a Sit-Stand test that measures the number of full stands from a seated position a participant can complete in 30 s with arms folded across the chest. A higher score reflects better performance.
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Lower Extremity Muscle Strength
2-Month
|
1.3 number of chair stands
Standard Error 0.2
|
1.8 number of chair stands
Standard Error 0.2
|
|
Lower Extremity Muscle Strength
6-Month
|
1.1 number of chair stands
Standard Error 0.2
|
1.7 number of chair stands
Standard Error 0.2
|
|
Lower Extremity Muscle Strength
12-Month
|
1.0 number of chair stands
Standard Error 0.2
|
1.6 number of chair stands
Standard Error 0.2
|
|
Lower Extremity Muscle Strength
18-Month
|
0.7 number of chair stands
Standard Error 0.2
|
1.4 number of chair stands
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, 2, 6, 12, and 18 monthsPopulation: The number analyzed at each time point varies due to loss to follow-up.
A change in Physical Endurance was measured by the 6-minute Distance Walk, which is a self-paced timed test of the total distance a person can walk in six minutes. A higher score reflects better performance.
Outcome measures
| Measure |
Fit and Strong!
n=210 Participants
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 Participants
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Physical Endurance
2-Month
|
22.9 meters walked
Standard Error 4.4
|
50.5 meters walked
Standard Error 4.4
|
|
Physical Endurance
6-Month
|
13.3 meters walked
Standard Error 5.2
|
29.3 meters walked
Standard Error 5.1
|
|
Physical Endurance
12-Month
|
10.0 meters walked
Standard Error 5.3
|
23.2 meters walked
Standard Error 5.3
|
|
Physical Endurance
18-Month
|
-0.6 meters walked
Standard Error 5.8
|
12.8 meters walked
Standard Error 5.8
|
Adverse Events
Fit and Strong!
Serious events: 1 serious events
Other events: 1 other events
Deaths: 3 deaths
Fit and Strong! Plus
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Fit and Strong!
n=210 participants at risk
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 participants at risk
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/210 • Number of events 1 • 18 months.
|
0.00%
0/203 • 18 months.
|
Other adverse events
| Measure |
Fit and Strong!
n=210 participants at risk
Fit \& Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
Fit and Strong!: Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
|
Fit and Strong! Plus
n=203 participants at risk
Fit \& Strong! Plus differs from Fit \& Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
Fit and Strong! Plus: The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
|
|---|---|---|
|
General disorders
Feeling faint/lightheaded
|
0.48%
1/210 • Number of events 1 • 18 months.
|
0.49%
1/203 • Number of events 1 • 18 months.
|
|
General disorders
Discomfort during exercise
|
0.00%
0/210 • 18 months.
|
1.5%
3/203 • Number of events 3 • 18 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place