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ArthritisPhase 3HARENCT00526201

Help Arthritis With Exercise in West Virginia

A Phase 3 study testing 12-weeks EnhanceFitness in people with Arthritis, run by Jennifer Hootman at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Arthritis
What is being tested?
12-weeks EnhanceFitness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
323 participants
Where
1 siteUnited States
Study dates
May 2009to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • West Virginia University

    Morgantown, West Virginia, 26506-9196

Other trials in United States

About this study

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

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.

Conditions
Arthritis
Being tested
12-weeks EnhanceFitness, Control
Keywords
Arthritis, Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia, Lupus
Medical subject headings
Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12-weeks EnhanceFitnessBehavioural

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

  • ControlBehavioural

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

Study groups in NCT00526201
Study groupRoleWhat they receive
ExerciseExperimentalSubjects will be randomized to exercise (12 week EnhanceFitness class) or a wait-list control group.
Receives: Behavioral: 12-weeks EnhanceFitness
ControlOtherWait-list control group will receive intervention after 12-weeks.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Severity

    Measured: 8 months

  2. Physical activity level

    Measured: 8 months

  3. Physical Function

    Measured: 8 months

Secondary outcomes (5)

  1. Health-related quality of life

    Measured: 8 months

  2. Arthritis self-efficacy

    Measured: 8 months

  3. Self-efficacy for exercise

    Measured: 8 months

  4. Exercise perceptions

    Measured: 8 months

  5. Social support

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startMay 2009
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00526201
Sponsor's protocol ID
CDC-NCCDPHP-AAMC-0944
Other IDs
AAMC-0944
Acronym
HARE
Status last verified
Dec 2015
First submitted
6 Sep 2007
Last updated
24 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Jones DL, Eicher JL, Fang W, Hootman JM. Effectiveness and Implementation of an EnhanceFitness Physical Activity Intervention Specifically in Adults With Arthritis: A RE-AIM Evaluation. Gerontologist. 2024 Jul 1;64(7):gnad157. doi: 10.1093/geront/gnad157.

    PubMed 38051008

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 12-weeks EnhanceFitness in people with Arthritis, run by Jennifer Hootman at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Severity (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00526201, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.

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