N/A
N=413
Fit and Strong! Plus Comparative Effectiveness Trial
Osteoarthritis · Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03180008 ↗Enrolled (actual)
413
Serious AEs
0.2%
Results posted
Apr 2024
Primary outcome: Primary: Dietary Intake — 2.1; 4.7; 0.8; 2.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fit and Strong! (Behavioral); Fit and Strong! Plus (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dietary Intake |
2.1; 4.7; 0.8; 2.0; 1.3; 0.6 | — |
| PRIMARY Body Weight |
-0.5; -2.0; -0.8; -2.0; -0.9; -1.7 | — |
| SECONDARY Physical Activity Engagement |
14.1; 29.1; 15.4; 17.5; 7.0; 11.6 | — |
| SECONDARY Lower Extremity Pain |
-0.5; -1.4; -0.6; -1.5; -0.7; -0.9 | — |
| SECONDARY Lower Extremity Stiffness |
-0.3; -0.6; -0.5; -0.5; -0.6; -0.5 | — |
| SECONDARY Lower Extremity Physical Function |
-1.9; -5.5; -1.7; -4.9; -2.0; -4.1 | — |
| SECONDARY Lower Extremity Muscle Strength |
1.3; 1.8; 1.1; 1.7; 1.0; 1.6 | — |
| SECONDARY Physical Endurance |
22.9; 50.5; 13.3; 29.3; 10.0; 23.2 | — |
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!.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03180008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.