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Fit and Strong! Plus Comparative Effectiveness Trial

Primary Purpose

Osteoarthritis, Overweight and Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit and Strong!
Fit and Strong! Plus
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fit and Strong!

Fit and Strong! Plus

Arm Description

Outcomes

Primary Outcome Measures

Diet change
As measured by a Food Frequency Questionnaire
5% weight loss
Change in weight

Secondary Outcome Measures

Physical activity participation
Minutes spent engaging in physical activity
Lower extremity pain
Measured by the WOMAC
Lower extremity stiffness
Measured by the WOMAC
Lower extremity physical function
Measured by the WOMAC
Lower extremity muscle strength
Measured by a Sit-Stand test
Physical endurance
Measured by the 6-minute Distance Walk

Full Information

First Posted
May 30, 2017
Last Updated
June 6, 2017
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03180008
Brief Title
Fit and Strong! Plus Comparative Effectiveness Trial
Official Title
Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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!.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fit and Strong!
Arm Type
Active Comparator
Arm Title
Fit and Strong! Plus
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Fit and Strong!
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fit and Strong! Plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diet change
Description
As measured by a Food Frequency Questionnaire
Time Frame
Baseline, 6, 12, and 18 months
Title
5% weight loss
Description
Change in weight
Time Frame
Baseline, 6, 12, and 18 months
Secondary Outcome Measure Information:
Title
Physical activity participation
Description
Minutes spent engaging in physical activity
Time Frame
Baseline, 2, 6, 12, and 18 months
Title
Lower extremity pain
Description
Measured by the WOMAC
Time Frame
Baseline, 2, 6, 12, and 18 months
Title
Lower extremity stiffness
Description
Measured by the WOMAC
Time Frame
Baseline, 2, 6, 12, and 18 months
Title
Lower extremity physical function
Description
Measured by the WOMAC
Time Frame
Baseline, 2, 6, 12, and 18 months
Title
Lower extremity muscle strength
Description
Measured by a Sit-Stand test
Time Frame
Baseline, 2, 6, 12, and 18 months
Title
Physical endurance
Description
Measured by the 6-minute Distance Walk
Time Frame
Baseline, 2, 6, 12, and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24316240
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.
Results Reference
background
PubMed Identifier
33022324
Citation
Fitzgibbon ML, Tussing-Humphreys L, Schiffer L, Smith-Ray R, Marquez DX, DeMott AD, Berbaum ML, Hughes SL. Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis. Prev Med. 2020 Dec;141:106267. doi: 10.1016/j.ypmed.2020.106267. Epub 2020 Oct 3.
Results Reference
derived

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Fit and Strong! Plus Comparative Effectiveness Trial

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