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

Osteoarthritis of the Knee Clinical Trial

— BOOST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394874
• Other study ID #: H133B100003-2
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: January 15, 2016

Study information

• Verified date: January 2019
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 15, 2016
• Est. primary completion date: January 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Behavioral:
• TLC
Computer-based telephone linked communication will be used to counsel subjects to adhere to their exercise program over time.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quadriceps strength	Isokinetic quadriceps strength will be assessed with a Biodex	Change in quadriceps strength from baseline to 24 months.
Secondary	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
Secondary	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

External Links

•   The ENACT Center at Boston University's Sargent College of Health and Rehabilitation Sciences.