Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA? (BOOST)
This study is currently recruiting participants.
Verified May 2013 by Boston University
Sponsor:
Boston University
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Kristin Baker, PhD, Boston University
ClinicalTrials.gov Identifier:
NCT01394874
First received: June 21, 2011
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
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 | Intervention |
|---|---|
|
Osteoarthritis of the Knee |
Behavioral: TLC |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA? |
Resource links provided by NLM:
Further study details as provided by Boston University:
Primary Outcome Measures:
- Exercise Adherence [ Time Frame: Average adherence over the 24 month follow-up period. ] [ Designated as safety issue: No ]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:
- Instruments [ Time Frame: Change in self-report pain and function from baseline to the 24 month interval. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kristin Baker, PhD, Research Assistant Professor, Boston University |
| ClinicalTrials.gov Identifier: | NCT01394874 History of Changes |
| Other Study ID Numbers: | H133B100003-2 |
| Study First Received: | June 21, 2011 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston University:
|
osteoarthritis exercise |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013