Evaluation of the Active Living Every Day Exercise Progra... | NCT00146367

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

NCT00146367

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Sep 14, 2005Estimated

Enrollment

355

Phase

Phase 2Phase 3

Conditions

Arthritis

Interventions

Active Living Every Day

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CDC-NCCDPHP-MM-0444

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Oct 2005

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2005

Last Update Posted Date

Sep 14, 2005Estimated

Name	Class
University of North Carolina	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

355

Name	Type	Description	Arm Group Labels	Other Names
Active Living Every Day	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer M Hootman, PhD	Centers for Disease Control and Prevention	Study Chair
Leigh F Callahan, PhD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid
D012216	Rheumatic Diseases
D009043	Motor Activity

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided