Clinical trial NCT00146367: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthritis
Keywords: arthritis
osteoarthritis
rheumatoid arthritis
rheumatic disease
exercise
physical activity
physical function
disability
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of North Carolina
First posted: 2005-09-07
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Physical Activity Level measured via CHAMPS instrument at baseline and 20 weeks
measure: Physical Fitness Level measued via 2 minute step test at baseline and 20 weeks
Secondary outcomes:
measure: Functional status measured via HAQ at baseline and 20 weeks
measure: Arthritis Self-efficacy measured at baseline and 20 weeks
measure: Health-related Quality of Life measured at baseline, 20 weeks, 6 months and 12 months
measure: Pain, fatigue and stiffness VAS at baseline and 20 weeks
measure: Activities of Daily Living measured at baseline, 20 weeks, 6 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Jennifer M Hootman, PhD
role: STUDY_CHAIR
affiliation: University of North Carolina, Chapel Hill
name: Leigh F Callahan, PhD
role: PRINCIPAL_INVESTIGATOR
References: