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Help Arthritis With Exercise in West Virginia (HARE)
This study is not yet open for participant recruitment.
Verified by Centers for Disease Control and Prevention, July 2008
First Received: September 6, 2007   Last Updated: July 31, 2008   History of Changes
Sponsors and Collaborators: Centers for Disease Control and Prevention
West Virginia University
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00526201
  Purpose

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.


Condition Intervention Phase
Arthritis
 Behavioral: 12-weeks EnhanceFitness
Behavioral: Control
 Phase III

MedlinePlus related topics: Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Arthritis Benefits of a Physical Activity Program in West Virginia: Evaluation of EnhanceFitness

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Pain Severity [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Physical activity level [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Physical Function [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Arthritis self-efficacy [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Self-efficacy for exercise [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Exercise perceptions [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: May 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise: Experimental
Subjects will be randomized to exercise (12 week EnhanceFitness class) or a wait-list control group.
Behavioral: 12-weeks EnhanceFitness
EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.
Control: No Intervention
Wait-list control group will receive intervention after 12-weeks.
Behavioral: Control
Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526201

Contacts
Contact: Dina L Jones, PhD, PT 304-293-1078 djones@hsc.wvu.edu
Contact: Jeanne M Goodman, MPA 304-293-9255 jmgoodman@hsc.wvu.edu

Locations
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506-9196
Sponsors and Collaborators
Centers for Disease Control and Prevention
West Virginia University
Investigators
Principal Investigator: Dina L Jones, PT, PHD West Virginia University
Study Director: Jennifer M Hootman, PhD Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: West Virginia University ( Dina L. Jones PT, PHD )
Study ID Numbers: CDC-NCCDPHP-AAMC-0944, AAMC-0944
Study First Received: September 6, 2007
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00526201     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Fibromyalgia
Lupus

Study placed in the following topic categories:
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Osteoarthritis
 Lupus
Joint Diseases
Arthritis
Arthritis, Rheumatoid

Additional relevant MeSH terms:
Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 07, 2009



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