Fit and Strong! Plus Comparative Effectiveness Trial

Not Applicable

Completed

Conditions: Osteoarthritis
Overweight and Obesity

Interventions: Behavioral: Fit and Strong! Plus
Behavioral: Fit and Strong!

Registration Number: NCT03180008

Lead Sponsor: University of Illinois at Chicago

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!.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 413

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fit and Strong! Plus	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!	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).

Primary Outcome Measures

Name	Time	Method
Body Weight	2, 6, 12, and 18 months	A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).
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.

Secondary Outcome Measures

Name	Time	Method
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 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 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.
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.
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 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.