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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knee||Behavioral: TLC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual 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 Osteoarthritis (OA)?|
|Actual Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 15, 2016|
|Actual Study Completion Date :||January 15, 2016|
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.
- 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.
- 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.
- Quadriceps strength [ Time Frame: Change in quadriceps strength from baseline to 24 months. ]Isokinetic quadriceps strength will be assessed with a Biodex
- 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
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Kristin Baker, PhD||Boston University Charles River Campus|