Fit and Strong! Plus Comparative Effectiveness Trial

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180008
• Other study ID #: 2012-0277
• Secondary ID: 1R01AG039374
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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!.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: February 28, 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Fitzgibbon ML, Tussing-Humphreys L, Schiffer L, Smith-Ray R, Demott AD, Martinez M, Berbaum ML, Huber GM, Hughes SL. FIT & STRONG! PLUS: DESCRIPTIVE DEMOGRAPHIC AND RISK CHARACTERISTICS IN A COMPARATIVE EFFECTIVENESS TRIAL FOR OLDER AFRICAN-AMERICAN ADULTS WITH OSTEOARTHRITIS. J Aging Res Clin Pract. 2018;7(1):9-16. doi: 10.14283/jarcp.2018.3. — View Citation

Hughes SL, Tussing-Humphreys L, Schiffer L, Smith-Ray R, Marquez DX, DeMott AD, Berbaum ML, Fitzgibbon ML. Fit & Strong! Plus Trial Outcomes for Obese Older Adults with Osteoarthritis. Gerontologist. 2020 Apr 2;60(3):558-570. doi: 10.1093/geront/gny146. — View Citation

Mears M, Tussing-Humphreys L, Cerwinske L, Tangney C, Hughes SL, Fitzgibbons M, Gomez-Perez S. Associations between Alternate Healthy Eating Index-2010, Body Composition, Osteoarthritis Severity, and Interleukin-6 in Older Overweight and Obese African American Females with Self-Reported Osteoarthritis. Nutrients. 2018 Dec 22;11(1):26. doi: 10.3390/nu11010026. — View Citation

Smith-Ray RL, Fitzgibbon ML, Tussing-Humphreys L, Schiffer L, Shah A, Huber GM, Braunschweig C, Campbell RT, Hughes SL. Fit and Strong! Plus: design of a comparative effectiveness evaluation of a weight management program for older adults with osteoarthritis. Contemp Clin Trials. 2014 Mar;37(2):178-88. doi: 10.1016/j.cct.2013.11.014. Epub 2013 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2, 6, 12, and 18 months
Primary	Body Weight	A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).	2, 6, 12, and 18 months
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.	2, 6, 12, and 18 months
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.	Baseline, 2, 6, 12, and 18 months
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.	Baseline, 2, 6, 12, and 18 months
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.	Baseline, 2, 6, 12, and 18 months
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.	Baseline, 2, 6, 12, and 18 months
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.	Baseline, 2, 6, 12, and 18 months