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

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ClinicalTrials.gov Identifier: NCT01394874
Recruitment Status : Unknown
Verified May 2013 by Kristin Baker, PhD, Boston University.
Recruitment status was:  Recruiting
First Posted : July 15, 2011
Last Update Posted : May 3, 2013
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Kristin Baker, PhD, Boston University

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis of the Knee Behavioral: TLC Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA?
Study Start Date : July 2011
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Exercise Adherence [ Time Frame: Average adherence over the 24 month follow-up period. ]
    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 :
  1. Instruments [ Time Frame: Change in self-report pain and function from baseline to the 24 month interval. ]
    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.

  2. Quadriceps strength [ Time Frame: Change in quadriceps strength from baseline to 24 months. ]
    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.

  3. Timed Physical Function tasks [ Time Frame: Change in timed physical function task over 24 months ]
    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.

  4. Exercise quality [ Time Frame: Average measure of exercise quality over 24 months ]
    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.



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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristin Baker, PhD, Research Assistant Professor, Boston University
ClinicalTrials.gov Identifier: NCT01394874     History of Changes
Other Study ID Numbers: H133B100003-2
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Kristin Baker, PhD, Boston University:
osteoarthritis
exercise

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