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

September 12, 2005 updated by: Centers for Disease Control and Prevention

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. To demonstrate that the ALED program can increase physical activity and fitness levels among people with arthritis.
  2. To demonstrate that the Active Living Every Day has arthritis-specific benefits.
  3. To evaluate the feasibility of disseminating the Active Living Every Day program through the NC public health network.

Study Type

Interventional

Enrollment

355

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (ESTIMATE)

September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCCDPHP-0444
  • CDC-NCCDPHP-MM-0444

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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