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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00252070
Other study ID # CDC-NCCDPHP-ASPH3497
Secondary ID ASPH3497
Status Completed
Phase Phase 2/Phase 3
First received November 10, 2005
Last updated September 6, 2007
Start date November 2005
Est. completion date January 2007

Study information

Verified date September 2007
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 study is to develop and evaluate a progressive, land-based exercise program, that includes muscular and aerobic conditioning, resistance and stabilization exercises and balance training, for persons with arthritis.


Description:

There is evidence that people with arthritis who participate in appropriate types of physical activity can improve physical function and pain management. Most existing programs focus on improving flexibility and balance. Less attention has been paid to conditioning and overall functional fitness. To address some of these concerns, this study will develop, evaluate, and implement a non-aquatic physical activity program to increase health-related functional fitness in community-dwelling adults with arthritis. Specific goals are:

1. To develop a systematic and progressive program (FEPA: Functional Exercise for Persons with Arthritis) that integrates muscular and aerobic conditioning, balance and trunk/pelvic stabilization exercises emphasizing joint-protective, multi-plane movement patterns that mimic those used in everyday activities.

2. Implement the FEPA program in an ethnically diverse, low SES community sample of older adults with arthritis.

3. Conduct process, outcomes and impact evaluations to assess the effectiveness of the FEPA program for increasing short- and immediate-term health and functional fitness outcomes.

4. Evaluate the sustainability of the FEPA program through a program logic model process and identify inputs, activities and outputs that contribute to successful program implementation and the building of community capacity to support long-term program maintenance.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

- Self-reported doctor-diagnosed arthritis

- No physical limitations precluding exercise participation

- Negative screen for CVD (PAR-Q)

- Age 20+

- English or Spanish speaking

Exclusion Criteria:

- Presence of any condition for which exercise is contraindicated

- Physical inability to complete exercise program

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Functional Exercise for People with Arthritis (FEPA)


Locations

Country Name City State
United States San Diego State University San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Six-minute walk
Primary 8-foot up-and-go
Primary Arm curl
Primary Back scratch
Primary AIMS-2
Secondary Arthritis self-efficacy
Secondary Physical activity level
Secondary Pain VAS
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