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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014