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

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146367
• Other study ID #: CDC-NCCDPHP-0444
• Secondary ID: CDC-NCCDPHP-MM-0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 2, 2005
• Last updated: September 12, 2005
• Start date: January 2004
• Est. completion date: October 2005

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

Intervention

Behavioral:
• Active Living Every Day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	University of North Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks
Primary	Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks
Secondary	Functional status measured via HAQ at baseline and 20 weeks
Secondary	Arthritis Self-efficacy measured at baseline and 20 weeks
Secondary	Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months
Secondary	Pain, fatigue and stiffness VAS at baseline and 20 weeks
Secondary	Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months