Evaluation of the Active Living Every Day Exercise Program for People With Arthritis
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Purpose
The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis |
Behavioral: Active Living Every Day |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Health Benefits of the Active Living Every Day Physical Activity Program Among Persons With Arthritis |
- Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks
- Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks
- Functional status measured via HAQ at baseline and 20 weeks
- Arthritis Self-efficacy measured at baseline and 20 weeks
- Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months
- Pain, fatigue and stiffness VAS at baseline and 20 weeks
- Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months
| Estimated Enrollment: | 355 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | October 2005 |
Evidence has shown that regular moderate-intensity physical activity improves symptoms and function in persons with arthritis. A 20-week behavior-based program was developed by the Cooper Institute, Brown University, and Human Kinetics to help people with sedentary lifestyles become and stay physically active. A randomized trial evaluated the effectiveness and efficacy of a similar program on which Active Living Every Day is based (ALED) on cardiovascular disease risk factors, cost-effectiveness, and cardiorespiratory fitness. However, the current research supporting ALED is limited for people with arthritis. The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. The primary goal will be accomplished through a twenty week randomized controlled trial conducted with 400 participants residing in the 17 Area Agencies on Aging housed in the Councils of Government in North Carolina, including both urban and rural counties. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.
Objectives:
- To demonstrate that the ALED program can increase physical activity and fitness levels among people with arthritis.
- To demonstrate that the Active Living Every Day has arthritis-specific benefits.
- To evaluate the feasibility of disseminating the Active Living Every Day program through the NC public health network.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Self-reported arthritis or chronic joint symptoms
- Currently exercising less than 3 times per week
- Plan to be in community for at least 1 year
- Physician release for participation in physical activity
Exclusion Criteria:
- Pregnancy
- Non-English speaking
- Cognitive impairment
- Serious medical condition where exercise is contradindicated
- Severe physical or mental impairment
Contacts and Locations| Study Chair: | Jennifer M Hootman, PhD | Centers for Disease Control and Prevention |
| Principal Investigator: | Leigh F Callahan, PhD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00146367 History of Changes |
| Other Study ID Numbers: | CDC-NCCDPHP-0444, CDC-NCCDPHP-MM-0444 |
| Study First Received: | September 2, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
arthritis osteoarthritis rheumatoid arthritis rheumatic disease |
exercise physical activity physical function disability |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013