search
Back to results

Evaluation of the Active Living Every Day Exercise Program for People With Arthritis

Primary Purpose

Arthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Active Living Every Day
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring arthritis, osteoarthritis, rheumatoid arthritis, rheumatic disease, exercise, physical activity, physical function, disability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 2, 2005
    Last Updated
    September 12, 2005
    Sponsor
    Centers for Disease Control and Prevention
    Collaborators
    University of North Carolina
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00146367
    Brief Title
    Evaluation of the Active Living Every Day Exercise Program for People With Arthritis
    Official Title
    Evaluation of the Health Benefits of the Active Living Every Day Physical Activity Program Among Persons With Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Centers for Disease Control and Prevention
    Collaborators
    University of North Carolina

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis
    Keywords
    arthritis, osteoarthritis, rheumatoid arthritis, rheumatic disease, exercise, physical activity, physical function, disability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    355 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Living Every Day
    Primary Outcome Measure Information:
    Title
    Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks
    Title
    Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks
    Secondary Outcome Measure Information:
    Title
    Functional status measured via HAQ at baseline and 20 weeks
    Title
    Arthritis Self-efficacy measured at baseline and 20 weeks
    Title
    Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months
    Title
    Pain, fatigue and stiffness VAS at baseline and 20 weeks
    Title
    Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer M Hootman, PhD
    Organizational Affiliation
    Centers for Disease Control and Prevention
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Leigh F Callahan, PhD
    Organizational Affiliation
    University of North Carolina, Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Active Living Every Day Exercise Program for People With Arthritis

    We'll reach out to this number within 24 hrs