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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knee||Behavioral: TLC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Telephone-linked Communication (TLC)
This group will receive the computer-based telephone counseling.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Kristin R Baker, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Contact: Kristin Baker, PhD 617-358-1637 email@example.com|
|Principal Investigator:||Kristin Baker, PhD||Boston University|