Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA? (BOOST)

This study is currently recruiting participants.
Verified May 2013 by Boston University
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Kristin Baker, PhD, Boston University
ClinicalTrials.gov Identifier:
NCT01394874
First received: June 21, 2011
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

The purpose of this intervention is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis.


Condition Intervention
Osteoarthritis of the Knee
Behavioral: TLC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA?

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Exercise Adherence [ Time Frame: Average adherence over the 24 month follow-up period. ] [ Designated as safety issue: No ]
    In the literature, adherence is assessed on a continuum as the number of sessions of exercises reported divided by prescribed. This does not provide information on how consistent a participant was in doing exercise and consistency of strength training is critical to its effectiveness. We developed a measure of adherence that reflects consistency, choosing a threshold of a minimum of 1 time per week for 80% of the weeks. An 80% threshold permits vacations/illness/life events that may limit exercise opportunities. We will also measure adherence by exercise sessions performed/sessions prescribed.


Secondary Outcome Measures:
  • Instruments [ Time Frame: Change in self-report pain and function from baseline to the 24 month interval. ] [ Designated as safety issue: No ]
    The Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC), National Institutes of Health, Patient Reported Outcomes Measurement Information System (NIH PROMIS) for physical function, and the Osteoarthritis computer adaptive test methodology (OA-CAT) instrument will be assessed at baseline, post the 1-month exercise class, at the 12 and 24 month follow-up clinic visits and by telephone at 6 and 18 months. We will examine the association of adherence, as a dichotomous and continuous variable, to change in pain and function on these instruments.

  • Quadriceps strength [ Time Frame: Change in quadriceps strength from baseline to 24 months. ] [ Designated as safety issue: No ]
    Isokinetic quadriceps strength will be assessed with a Biodex at baseline, post the 1-month exercise class and at the 12 and 24 month follow-up clinic visits. The association of adherence as a dichotomous and continuous variable to change in quadriceps strength will be assessed.

  • Timed Physical Function tasks [ Time Frame: Change in timed physical function task over 24 months ] [ Designated as safety issue: No ]
    Timed physical function tasks will include a timed get up and go, timed stair ascent and descent, and a 5 and 10 chair stand time. We will examine the association of adherence, as a dichotomous and continuous variable, to change in timed physical function using logistic and linear regression, respectively.

  • Exercise quality [ Time Frame: Average measure of exercise quality over 24 months ] [ Designated as safety issue: No ]
    The outcome will be assessed at the end of the 24 month follow-up period as the number of calendar periods (1 month per calendar period) that the participant exercises at least half the number of prescribed sessions (a minimum of 6 out of 12 over a 4 week period) with the agreed upon level of intensity.


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone-linked Communication (TLC)
This group will receive the computer-based telephone counseling.
Behavioral: TLC
Computer-based telephone linked communication will be used to counsel subjects to adhere to their exercise program over time.
No Intervention: Control
This is the control group. They will receive the exercise class, however, they will not receive the telephone counseling.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis of the knee (ICD-9 Code of 715.16, 715.09 or 715.9)
  • lives within interstate 95
  • age 55 or older
  • English speaking

Exclusion Criteria:

  • Stroke or MI in last 3 months
  • Treatment for cancer
  • Severe systemic disease
  • Medical condition that limits p.a.
  • Inflammatory arthritis
  • Plans for knee replacement
  • Dementia or inability to follow exercise instructions and TLC system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394874

Contacts
Contact: Kristin R Baker, PhD 617-358-1637 krbaker@bu.edu

Locations
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kristin Baker, PhD    617-358-1637    krbaker@bu.edu   
Sponsors and Collaborators
Boston University
U.S. Department of Education
Investigators
Principal Investigator: Kristin Baker, PhD Boston University
  More Information

Additional Information:
No publications provided

Responsible Party: Kristin Baker, PhD, Research Assistant Professor, Boston University
ClinicalTrials.gov Identifier: NCT01394874     History of Changes
Other Study ID Numbers: H133B100003-2
Study First Received: June 21, 2011
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
osteoarthritis
exercise

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014