Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA?

Study Overview
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Brief Summary
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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.

Official Title
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Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee Osteoarthritis (OA)?

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Behavioral: TLC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-linked Communication (TLC)<br>This group will receive the computer-based telephone counseling. | Behavioral: TLC<br>* Computer-based telephone linked communication will be used to counsel subjects to adhere to their exercise program over time.<br>|
| No Intervention: Control<br>This is the control group. They will receive the exercise class, however, they will not receive the telephone counseling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report measure of exercise adherence over the last 3-months on a numeric rating scale | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 -month change in self-report of pain and function using the WOMAC index | 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. | post the 1-month exercise class, 24 months | 
| Quadriceps strength | Isokinetic quadriceps strength will be assessed with a Biodex | Change in quadriceps strength from baseline to 24 months. | 
| Timed Physical Function tasks | 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. | Change in timed physical function task over 24 months | 
| Exercise quality | 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. | Average measure of exercise quality over 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, exercise