NCT00000434

Brief Summary

Previous studies have found that exercise can reduce pain, improve endurance for physical activities, and improve cardiovascular fitness over time. However, these studies have not looked at the impact of exercise programs for older adults with osteoarthritis or at how long older adults continue exercising after a program is finished. This study will look at the long-term effects of a structured exercise program for people aged 60 or older who have osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older people with osteoarthritis to continue exercising. We will randomly assign study participants to either the exercise program or a control group that does not do the exercise program. We will monitor participants at the start of the study, at 8 weeks, and every 3 months for 2 years after the program is completed. The exercise program lasts for 8 weeks and includes an exercise part and an educational part led by trained physical therapists. We believe that participants in the treatment (exercise) group will show higher rates of continued exercise and higher functional status over time compared to the group of people who do not participate in the exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 1983

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

December 1, 1983

Completed
16.2 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2000

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

August 22, 2019

Status Verified

December 1, 2007

Enrollment Period

19.8 years

First QC Date

January 21, 2000

Last Update Submit

August 20, 2019

Conditions

Osteoarthritis

Keywords

OsteoarthritisHealth educationAerobic exerciseSelf-efficacyMuscle strengthOutcomes researchLongitudinal study

Outcome Measures

Primary Outcomes (1)

  • Adherence to exercise

    12 months

Secondary Outcomes (1)

  • Pain and stiffness

    12 months

Study Arms (1)

1

EXPERIMENTAL

Fit and Strong! is a multi-component exercise and health education program that incorporates flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.

Behavioral: Fit and Strong!

Interventions

Fit and Strong!BEHAVIORAL

Fit and Strong! is a multi-component exercise and health education program that includes flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.

1

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 of the lower extremities with an American College of Rheumatology functional class rating of I, II, or III
  • No other contraindication from a personal physician for participation in the fitness walking
  • Lack of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire

You may not qualify if:

  • Under 60 years of age
  • Lack of osteoarthritis of the lower extremities
  • Contraindication from a personal physician for participation in fitness walking
  • Presence of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
  • Steroid injections in either hip or knee within the previous 6 months
  • Uncomplicated knee or hip surgery within previous year
  • Complicated knee or hip surgery within previous year
  • Plans for total knee or hip replacement within the next year
  • Rheumatoid arthritis or other systemic inflammatory arthritis
  • Diabetes that is not under control
  • Current participation in a structured aerobic exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Park Village

Chicago, Illinois, 60646, United States

Location

Bernard Horwich Jewish Community Center

Chicago, Illinois, 60659, United States

Location

Related Publications (2)

  • 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

MeSH Terms

Conditions

OsteoarthritisHealth Education

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Susan Hughes

    Center for Research on Health and Aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

January 21, 2000

First Posted

January 24, 2000

Study Start

December 1, 1983

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

August 22, 2019

Record last verified: 2007-12

Locations

US(2)