NCT00421681

Brief Summary

The purpose of this study is to assess the comparative effects of two different ways of enhancing long-term adherence to and benefits associated with participation in the evidence-based, Fit and Strong multi-component exercise intervention for older persons with lower extremity osteoarthritis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 14, 2009

Status Verified

January 1, 2008

Enrollment Period

4.9 years

First QC Date

January 10, 2007

Last Update Submit

December 10, 2009

Conditions

Keywords

Agingexercisehealth behavior

Outcome Measures

Primary Outcomes (1)

  • Maintenance of exercise behavior measured by CHAMPS (Community Healthy Activities Model Program For Seniors)

    Baseline, 2 months, 6 months, 12 months, 18 months

Secondary Outcomes (4)

  • Changes in lower extremity strength (timed sit-stand test)

    Baseline, 2 months, 6 months, 12 months, 18 months

  • Aerobic capacity (6 minute distance walk)

    Baseline, 2 months, 6 months, 12 months, 18 months

  • Pain, stiffness, physical function subscales measured by WOMAC (Western Ontario and McMaster osteoarthritis index)

    Baseline, 2 months, 6 months, 12 months, 18 months

  • Functional ability measured by GeriAIMS (Geriatric Arthritis Impact Measurement Scale)

    Baseline, 2 months, 6 months, 12 months, 18 months

Study Arms (2)

A

EXPERIMENTAL

Treatment Arm A will develop tailored/negotiated contracts with the exercise instructor to maintain post intervention exercise adherence at home or in the community. Half of the participants in this "negotiated maintenance" arm will be randomly assigned to receive telephone calls to reinforce adherence and half will be assigned to a no telephone calls group.

Behavioral: Fit and Strong! Exercise Program

B

EXPERIMENTAL

Treatment Arm B will be mainstreamed into an ongoing facility-based exercise program for post intervention exercise adherence. Persons in this "mainstream follow up" arm will be randomly assigned such that half will receive regular telephone reinforcement follow up and half will not.

Behavioral: Fit and Strong! Exercise Program

Interventions

Fit and Strong! is an 8-week (24 sessions) multi-component exercise and health education intervention, including flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change. Following participation in Fit and Strong!, all study participants are randomly assigned to one of 2 maintenance treatment follow-up groups.

AB

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Presence of osteoarthritis in the lower extremities (including hip, knee, ankle, feet and lower back) with an American College of Rheumatology functional class rating of I, II, or III
  • No other contraindication from a personal physician for participation in fitness walking or low-impact aerobics and strength training
  • Lack of moderate to severe cognitive impairment shown as assessed by the Short Portable Mental Status Questionnaire

You may not qualify if:

  • Under 60 years of age
  • Lack of osteoarthritis in the lower extremities
  • Contraindication from a personal physician for participation in activities described above
  • Presence of moderate to severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
  • Steroid injections in either knee or hip within previous six months
  • Knee or hip surgery within previous six months
  • Plans for total knee or hip replacement within the next year
  • Rheumatoid arthritis or other system inflammatory arthritis
  • Diabetes that is not under good control
  • Current participation in a structured aerobic exercise program
  • Participation in original trial of the Fit and Strong Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research on Health and Aging

Chicago, Illinois, 60608, United States

Location

Related Publications (3)

  • Hughes SL, Seymour RB, Campbell R, Pollak N, Huber G, Sharma L. Impact of the fit and strong intervention on older adults with osteoarthritis. Gerontologist. 2004 Apr;44(2):217-28. doi: 10.1093/geront/44.2.217.

    PMID: 15075418BACKGROUND
  • Hughes SL, Seymour RB, Campbell RT, Huber G, Pollak N, Sharma L, Desai P. Long-term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006 Dec;46(6):801-14. doi: 10.1093/geront/46.6.801.

    PMID: 17169935BACKGROUND
  • Seymour RB, Hughes SL, Campbell RT, Huber GM, Desai P. Comparison of two methods of conducting the Fit and Strong! program. Arthritis Rheum. 2009 Jul 15;61(7):876-84. doi: 10.1002/art.24517.

MeSH Terms

Conditions

OsteoarthritisMotor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Susan Hughes, DSW

    Center for Research on Health and Aging , University of Illinois, Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 12, 2007

Study Start

October 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 14, 2009

Record last verified: 2008-01

Locations