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Trial record 1 of 1 for:    NCT01394874
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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 : Completed
First Posted : July 15, 2011
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Boston University Charles River Campus

Brief Summary:
The purpose of this research 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

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Study Type : Interventional  (Clinical Trial)
Actual 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 Osteoarthritis (OA)?
Actual Study Start Date : July 2011
Actual Primary Completion Date : January 15, 2016
Actual Study Completion Date : January 15, 2016

Resource links provided by the National Library of Medicine


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. Self-report measure of exercise adherence over the last 3-months on a numeric rating scale [ Time Frame: 24 month ]
    Exercise adherence was assessed by the single self-report item "How would you rate your level of adherence to the prescribed BOOST exercise program, over the last 3 MONTHS?" Participants selected a number from 0 (not at all) to 10 (completely as instructed). Higher scores reflect better adherence.


Secondary Outcome Measures :
  1. 24 -month change in self-report of pain and function using the WOMAC index [ Time Frame: post the 1-month exercise class, 24 months ]

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales:

    Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of bath, sitting, getting on/off toilet, heavy domestic duties, light domestic duties Responses to individual questions [between 0 (extreme) and 4 (None)] are summed to a raw score ranging from 0 (worst) to 96 (best) and then normalized to a WOMAC Score of between 0 (worst) to 100 (best). The difference in pain and function subscale values between the measures following the exercise class and the 24-month follow-up were used for secondary outcomes.


  2. Quadriceps strength [ Time Frame: Change in quadriceps strength from baseline to 24 months. ]
    Isokinetic quadriceps strength will be assessed with a Biodex

  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, Older Adult)
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 heart attack in last 3 months
  • Treatment for cancer
  • Severe systemic disease
  • Medical condition that limits physical activity
  • 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


Locations
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United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus
U.S. Department of Education
Investigators
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Principal Investigator: Kristin Baker, PhD Boston University Charles River Campus

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT01394874     History of Changes
Other Study ID Numbers: H133B100003-2
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston University Charles River Campus:
osteoarthritis
exercise

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