NCT00526201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

September 6, 2007

Last Update Submit

December 22, 2015

Conditions

Arthritis

Keywords

ArthritisOsteoarthritisRheumatoid ArthritisFibromyalgiaLupus

Outcome Measures

Primary Outcomes (3)

  • Pain Severity

    8 months

  • Physical activity level

    8 months

  • Physical Function

    8 months

Secondary Outcomes (5)

  • Health-related quality of life

    8 months

  • Arthritis self-efficacy

    8 months

  • Self-efficacy for exercise

    8 months

  • Exercise perceptions

    8 months

  • Social support

    8 months

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: 12-weeks EnhanceFitness

Control

OTHER

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

Behavioral: Control

Interventions

12-weeks EnhanceFitnessBEHAVIORAL

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

Exercise
ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506-9196, United States

Location

Related Publications (1)

  • 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.

    PMID: 38051008DERIVED

MeSH Terms

Conditions

ArthritisOsteoarthritisArthritis, RheumatoidFibromyalgia

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Dina L Jones, PT, PHD

    West Virginia University

    PRINCIPAL INVESTIGATOR

  • Jennifer M Hootman, PhD

    Centers for Disease Control and Prevention

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Epidemiologist

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

May 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(1)