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Help Arthritis With Exercise in West Virginia (HARE)

Primary Purpose

Arthritis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

12-weeks EnhanceFitness

Control

About this trial

This is an interventional treatment trial for Arthritis focused on measuring Arthritis, Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia, Lupus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 and older
Any type of self-reported, doctor-diagnosed arthritis

Exclusion Criteria:

Any co-existing conditions where exercise is a contraindicated
Impaired cognitive status
Non-ambulatory

Sites / Locations

West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercise

Control

Arm Description

Subjects will be randomized to exercise (12 week EnhanceFitness class) or a wait-list control group.

Wait-list control group will receive intervention after 12-weeks.

Outcomes

Primary Outcome Measures

Pain Severity

Physical activity level

Physical Function

Secondary Outcome Measures

Health-related quality of life

Arthritis self-efficacy

Self-efficacy for exercise

Exercise perceptions

Social support

Full Information

NCT ID

NCT00526201

First Posted

September 6, 2007

Last Updated

December 22, 2015

Sponsor

Jennifer Hootman

Collaborators

West Virginia University

1. Study Identification

Unique Protocol Identification Number

NCT00526201

Brief Title

Help Arthritis With Exercise in West Virginia

Acronym

HARE

Official Title

Arthritis Benefits of a Physical Activity Program in West Virginia: Evaluation of EnhanceFitness

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jennifer Hootman

Collaborators

West Virginia University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this project is to determine if an evidence-based, community-delivered physical activity program, EnhanceFitness, yields benefits for participants with arthritis. The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a randomized, controlled (wait list) design, and 3) disseminate the results to community and public health partners. It is anticipated that participation in the EnhanceFitness program will result in reduced pain, improved physical function and physical activity levels for adults with arthritis.

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, Fibromyalgia, Lupus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

323 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Subjects will be randomized to exercise (12 week EnhanceFitness class) or a wait-list control group.

Arm Title

Control

Arm Type

Other

Arm Description

Wait-list control group will receive intervention after 12-weeks.

Intervention Type

Behavioral

Intervention Name(s)

12-weeks EnhanceFitness

Intervention Description

EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).

Primary Outcome Measure Information:

Title

Pain Severity

Time Frame

8 months

Title

Physical activity level

Time Frame

8 months

Title

Physical Function

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Health-related quality of life

Time Frame

8 months

Title

Arthritis self-efficacy

Time Frame

8 months

Title

Self-efficacy for exercise

Time Frame

8 months

Title

Exercise perceptions

Time Frame

8 months

Title

Social support

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 and older Any type of self-reported, doctor-diagnosed arthritis Exclusion Criteria: Any co-existing conditions where exercise is a contraindicated Impaired cognitive status Non-ambulatory

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina L Jones, PT, PHD

Organizational Affiliation

West Virginia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jennifer M Hootman, PhD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Study Director

Facility Information:

Facility Name

West Virginia University

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506-9196

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Help Arthritis With Exercise in West Virginia

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