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Completed

NCT Number: NCT00146367

Evaluation of the Active Living Every Day Exercise Program 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. 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.

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Key information

Conditions

Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Living Every Day

Behavioral

Primary outcomes

  1. Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks

  2. Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks

Secondary outcomes

  1. Functional status measured via HAQ at baseline and 20 weeks

  2. Arthritis Self-efficacy measured at baseline and 20 weeks

  3. Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months

  4. Pain, fatigue and stiffness VAS at baseline and 20 weeks

  5. Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • University of North Carolina

Registry information

Official study title

Evaluation of the Health Benefits of the Active Living Every Day Physical Activity Program Among Persons With Arthritis

Important dates

Study start
2004
Study completion
2005
First posted
Sep 7, 2005
Registry last updated
Sep 14, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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