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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00526201
Other study ID # CDC-NCCDPHP-AAMC-0944
Secondary ID AAMC-0944
Status Completed
Phase Phase 3
First received September 6, 2007
Last updated December 22, 2015
Start date May 2009
Est. completion date January 2011

Study information

Verified date December 2015
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this project is to determine if an evidence-based, community-delivered physical activity program, EnhanceFitness, yields benefits for participants with arthritis. The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a randomized, controlled (wait list) design, and 3) disseminate the results to community and public health partners. It is anticipated that participation in the EnhanceFitness program will result in reduced pain, improved physical function and physical activity levels for adults with arthritis.


Recruitment information / eligibility

Status Completed
Enrollment 323
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Age 18 and older

- Any type of self-reported, doctor-diagnosed arthritis

Exclusion Criteria:

- Any co-existing conditions where exercise is a contraindicated

- Impaired cognitive status

- Non-ambulatory

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
12-weeks EnhanceFitness
EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.
Control
Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).

Locations

Country Name City State
United States West Virginia University Morgantown West Virginia

Sponsors (2)

Lead Sponsor Collaborator
Jennifer Hootman West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Severity 8 months No
Primary Physical activity level 8 months No
Primary Physical Function 8 months No
Secondary Health-related quality of life 8 months No
Secondary Arthritis self-efficacy 8 months Yes
Secondary Self-efficacy for exercise 8 months No
Secondary Exercise perceptions 8 months No
Secondary Social support 8 months No
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