Osteoarthritis, Overweight and Obesity
Conditions
Brief summary
This randomized controlled trial is comparing outcomes of customary Fit and Strong!, to Fit and Strong! Plus, an enhanced version of the program that incorporates weight management. We hypothesize that Fit and Strong! Plus participants will show improved diet behaviors at 2, 6, 12, and 18 months that will be accompanied by a significant 5% weight loss at 6 months and maintained to 18 months, compared to participants in customary Fit and Strong!.
Interventions
BEHAVIORALFit 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.
BEHAVIORALFit 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.
Sponsors
National Institute on Aging (NIA)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Presence of symptoms of lower extremity osteoarthritis * Age 60 or older * Not currently participating in a regular physical activity program * BMI 25-50 * Able to attend Fit and Strong! classes
Exclusion criteria
* Score of 3 or greater on Mental Status Questionnaire * Recent hip or knee surgery * Recent steroid injection into hip or knee * Diagnosis of rheumatoid arthritis * Uncontrolled diabetes * Unspecified health conditions that may interfere with exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake | 2, 6, 12, and 18 months | 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. |
| Body Weight | 2, 6, 12, and 18 months | A change in body weight (kilograms) measured using a calibrated digital scale (Tanita). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Muscle Strength | Baseline, 2, 6, 12, and 18 months | 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. |
| Physical Endurance | Baseline, 2, 6, 12, and 18 months | 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. |
| Lower Extremity Stiffness | Baseline, 2, 6, 12, and 18 months | 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. |
| Lower Extremity Pain | Baseline, 2, 6, 12, and 18 months | 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. |
| Physical Activity Engagement | 2, 6, 12, and 18 months | 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. |
| Lower Extremity Physical Function | Baseline, 2, 6, 12, and 18 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 210 |
| 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. | 203 |
| Total | 413 |
Baseline characteristics
| Characteristic | Fit and Strong! | Total | Fit and Strong! Plus |
|---|---|---|---|
| Age, Continuous | 68 Years STANDARD_DEVIATION 6 | 68 Years STANDARD_DEVIATION 6 | 68 Years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 202 Participants | 397 Participants | 195 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 193 Participants | 380 Participants | 187 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) White | 11 Participants | 22 Participants | 11 Participants |
| Region of Enrollment United States | 210 participants | 413 participants | 203 participants |
| Sex: Female, Male Female | 178 Participants | 355 Participants | 177 Participants |
| Sex: Female, Male Male | 32 Participants | 58 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 210 | 4 / 203 |
| other Total, other adverse events | 1 / 210 | 4 / 203 |
| serious Total, serious adverse events | 1 / 210 | 0 / 203 |
Outcome results
Primary
Body Weight
A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).
Time frame: 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Body Weight | 2-Month Follow-up | -0.5 Kilograms | Standard Error 0.2 |
| Fit and Strong! | Body Weight | 6-Month Follow-up | -0.8 Kilograms | Standard Error 0.3 |
| Fit and Strong! | Body Weight | 12-Month Follow-up | -0.9 Kilograms | Standard Error 0.3 |
| Fit and Strong! | Body Weight | 18-Month Follow-up | -0.9 Kilograms | Standard Error 0.3 |
| Fit and Strong! Plus | Body Weight | 18-Month Follow-up | -1.3 Kilograms | Standard Error 0.3 |
| Fit and Strong! Plus | Body Weight | 2-Month Follow-up | -2.0 Kilograms | Standard Error 0.2 |
| Fit and Strong! Plus | Body Weight | 12-Month Follow-up | -1.7 Kilograms | Standard Error 0.3 |
| Fit and Strong! Plus | Body Weight | 6-Month Follow-up | -2.0 Kilograms | Standard Error 0.3 |
Primary
Dietary Intake
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.
Time frame: 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Dietary Intake | 2-Month Follow-up | 2.1 score on a scale | Standard Error 0.7 |
| Fit and Strong! | Dietary Intake | 6-Month Follow-up | 0.8 score on a scale | Standard Error 0.7 |
| Fit and Strong! | Dietary Intake | 12-Month Follow-up | 1.3 score on a scale | Standard Error 0.7 |
| Fit and Strong! | Dietary Intake | 18-Month Follow-up | 0.0 score on a scale | Standard Error 0.7 |
| Fit and Strong! Plus | Dietary Intake | 18-Month Follow-up | 1.0 score on a scale | Standard Error 0.7 |
| Fit and Strong! Plus | Dietary Intake | 2-Month Follow-up | 4.7 score on a scale | Standard Error 0.7 |
| Fit and Strong! Plus | Dietary Intake | 12-Month Follow-up | 0.6 score on a scale | Standard Error 0.7 |
| Fit and Strong! Plus | Dietary Intake | 6-Month Follow-up | 2.0 score on a scale | Standard Error 0.7 |
Secondary
Lower Extremity Muscle Strength
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.
Time frame: Baseline, 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Lower Extremity Muscle Strength | 2-Month | 1.3 number of chair stands | Standard Error 0.2 |
| Fit and Strong! | Lower Extremity Muscle Strength | 6-Month | 1.1 number of chair stands | Standard Error 0.2 |
| Fit and Strong! | Lower Extremity Muscle Strength | 12-Month | 1.0 number of chair stands | Standard Error 0.2 |
| Fit and Strong! | Lower Extremity Muscle Strength | 18-Month | 0.7 number of chair stands | Standard Error 0.2 |
| Fit and Strong! Plus | Lower Extremity Muscle Strength | 18-Month | 1.4 number of chair stands | Standard Error 0.2 |
| Fit and Strong! Plus | Lower Extremity Muscle Strength | 2-Month | 1.8 number of chair stands | Standard Error 0.2 |
| Fit and Strong! Plus | Lower Extremity Muscle Strength | 12-Month | 1.6 number of chair stands | Standard Error 0.2 |
| Fit and Strong! Plus | Lower Extremity Muscle Strength | 6-Month | 1.7 number of chair stands | Standard Error 0.2 |
Secondary
Lower Extremity Pain
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.
Time frame: Baseline, 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Lower Extremity Pain | 2-Month Follow | -0.5 Score on a scale | Standard Error 0.2 |
| Fit and Strong! | Lower Extremity Pain | 6-Month | -0.6 Score on a scale | Standard Error 0.3 |
| Fit and Strong! | Lower Extremity Pain | 18-Month | -0.1 Score on a scale | Standard Error 0.3 |
| Fit and Strong! | Lower Extremity Pain | 12-Month | -0.7 Score on a scale | Standard Error 0.3 |
| Fit and Strong! Plus | Lower Extremity Pain | 18-Month | -0.9 Score on a scale | Standard Error 0.3 |
| Fit and Strong! Plus | Lower Extremity Pain | 6-Month | -1.5 Score on a scale | Standard Error 0.3 |
| Fit and Strong! Plus | Lower Extremity Pain | 12-Month | -0.9 Score on a scale | Standard Error 0.3 |
| Fit and Strong! Plus | Lower Extremity Pain | 2-Month Follow | -1.4 Score on a scale | Standard Error 0.2 |
Secondary
Lower Extremity Physical Function
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.
Time frame: Baseline, 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Lower Extremity Physical Function | 2-Month | -1.9 score on a scale | Standard Error 0.7 |
| Fit and Strong! | Lower Extremity Physical Function | 6-Month | -1.7 score on a scale | Standard Error 0.9 |
| Fit and Strong! | Lower Extremity Physical Function | 12-Month | -2.0 score on a scale | Standard Error 0.9 |
| Fit and Strong! | Lower Extremity Physical Function | 18-Month | -2.6 score on a scale | Standard Error 0.9 |
| Fit and Strong! Plus | Lower Extremity Physical Function | 18-Month | -3.5 score on a scale | Standard Error 0.9 |
| Fit and Strong! Plus | Lower Extremity Physical Function | 2-Month | -5.5 score on a scale | Standard Error 0.8 |
| Fit and Strong! Plus | Lower Extremity Physical Function | 12-Month | -4.1 score on a scale | Standard Error 0.9 |
| Fit and Strong! Plus | Lower Extremity Physical Function | 6-Month | -4.9 score on a scale | Standard Error 0.9 |
Secondary
Lower Extremity Stiffness
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.
Time frame: Baseline, 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Lower Extremity Stiffness | 2-Month | -0.3 score on a scale | Standard Error 0.1 |
| Fit and Strong! | Lower Extremity Stiffness | 6-Month | -0.5 score on a scale | Standard Error 0.1 |
| Fit and Strong! | Lower Extremity Stiffness | 12-Month | -0.6 score on a scale | Standard Error 0.1 |
| Fit and Strong! | Lower Extremity Stiffness | 18-Month | -0.6 score on a scale | Standard Error 0.1 |
| Fit and Strong! Plus | Lower Extremity Stiffness | 18-Month | -0.4 score on a scale | Standard Error 0.1 |
| Fit and Strong! Plus | Lower Extremity Stiffness | 2-Month | -0.6 score on a scale | Standard Error 0.1 |
| Fit and Strong! Plus | Lower Extremity Stiffness | 12-Month | -0.5 score on a scale | Standard Error 0.1 |
| Fit and Strong! Plus | Lower Extremity Stiffness | 6-Month | -0.5 score on a scale | Standard Error 0.1 |
Secondary
Physical Activity Engagement
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.
Time frame: 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Physical Activity Engagement | 2 months | 14.1 score on a scale | Standard Error 4.7 |
| Fit and Strong! | Physical Activity Engagement | 6 months | 15.4 score on a scale | Standard Error 5 |
| Fit and Strong! | Physical Activity Engagement | 12 months | 7.0 score on a scale | Standard Error 4.8 |
| Fit and Strong! | Physical Activity Engagement | 18 months | 5.2 score on a scale | Standard Error 4.8 |
| Fit and Strong! Plus | Physical Activity Engagement | 18 months | 12.2 score on a scale | Standard Error 4.9 |
| Fit and Strong! Plus | Physical Activity Engagement | 2 months | 29.1 score on a scale | Standard Error 4.8 |
| Fit and Strong! Plus | Physical Activity Engagement | 12 months | 11.6 score on a scale | Standard Error 4.9 |
| Fit and Strong! Plus | Physical Activity Engagement | 6 months | 17.5 score on a scale | Standard Error 5 |
Secondary
Physical Endurance
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.
Time frame: Baseline, 2, 6, 12, and 18 months
Population: The number analyzed at each time point varies due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fit and Strong! | Physical Endurance | 2-Month | 22.9 meters walked | Standard Error 4.4 |
| Fit and Strong! | Physical Endurance | 6-Month | 13.3 meters walked | Standard Error 5.2 |
| Fit and Strong! | Physical Endurance | 12-Month | 10.0 meters walked | Standard Error 5.3 |
| Fit and Strong! | Physical Endurance | 18-Month | -0.6 meters walked | Standard Error 5.8 |
| Fit and Strong! Plus | Physical Endurance | 18-Month | 12.8 meters walked | Standard Error 5.8 |
| Fit and Strong! Plus | Physical Endurance | 2-Month | 50.5 meters walked | Standard Error 4.4 |
| Fit and Strong! Plus | Physical Endurance | 12-Month | 23.2 meters walked | Standard Error 5.3 |
| Fit and Strong! Plus | Physical Endurance | 6-Month | 29.3 meters walked | Standard Error 5.1 |