Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA? (BOOST)
|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|
|Osteoarthritis of the Knee||Behavioral: TLC|
|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.
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|