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Completed

NCT Number: NCT01394874

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLC

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Quadriceps strength

    Time frame: Change in quadriceps strength from baseline to 24 months.

    Isokinetic quadriceps strength will be assessed with a Biodex

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

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

Acronym: BOOST

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2011
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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