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
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
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
NCT ID
NCT00146367
First Posted
September 2, 2005
Last Updated
September 12, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of North Carolina
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
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