CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 413 enrolled
Drug / intervention
Fit and Strong! +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • Symptoms of lower extremity osteoarthritis
  • Age 60 years or older
  • BMI between 25 and 50
  • Not currently in a regular physical activity program
Key exclusion· 5
  • Cognitive impairment (Mental Status Questionnaire score ≥3)
  • Recent hip or knee surgery
  • Recent steroid injection into hip or knee
  • Rheumatoid arthritis diagnosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03180008
NCT03180008N/ACompleted

Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!

University of Illinois at Chicago·interventional·Posted Jun 7, 2017·Updated Apr 19, 2024

In Brief

A clinical study evaluating Fit and Strong! and Fit and Strong! Plus for Osteoarthritis and Overweight and Obesity. Completed, enrolled 413 participants across 1 site.

Detailed 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!.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2017
Enrollment StartDec 1, 2012
Primary CompletionJan 31, 2018
Study CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.1 years ago

Interventions

Fit and Strong!behavioral

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! Plusbehavioral

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.