Fit and Strong! Plus Comparative Effectiveness Trial

University of Illinois

Status: Completed

Conditions: Osteoarthritis; Overweight and Obesity

Treatments: Behavioral: Fit and Strong!; Behavioral: Fit and Strong! Plus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03180008

1R01AG039374 (U.S. NIH Grant/Contract)

2012-0277 (Other Identifier)

Details and patient eligibility

About

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!.

Enrollment: 413 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

413 participants in 2 patient groups

Fit and Strong!

Active Comparator group

Description:

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).

Treatment:

Behavioral: Fit and Strong!

Fit and Strong! Plus

Experimental group

Description:

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.

Treatment:

Behavioral: Fit and Strong! Plus