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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TLC
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, exercise

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone-linked Communication (TLC)

Control

Arm Description

This group will receive the computer-based telephone counseling.

This is the control group. They will receive the exercise class, however, they will not receive the telephone counseling.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Quadriceps strength
Isokinetic quadriceps strength will be assessed with a Biodex
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.
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.

Full Information

First Posted
June 21, 2011
Last Updated
January 15, 2019
Sponsor
Boston University Charles River Campus
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT01394874
Brief Title
Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA?
Acronym
BOOST
Official Title
Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee Osteoarthritis (OA)?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
January 15, 2016 (Actual)
Study Completion Date
January 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone-linked Communication (TLC)
Arm Type
Experimental
Arm Description
This group will receive the computer-based telephone counseling.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This is the control group. They will receive the exercise class, however, they will not receive the telephone counseling.
Intervention Type
Behavioral
Intervention Name(s)
TLC
Intervention Description
Computer-based telephone linked communication will be used to counsel subjects to adhere to their exercise program over time.
Primary Outcome Measure Information:
Title
Self-report measure of exercise adherence over the last 3-months on a numeric rating scale
Description
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.
Time Frame
24 month
Secondary Outcome Measure Information:
Title
24 -month change in self-report of pain and function using the WOMAC index
Description
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.
Time Frame
post the 1-month exercise class, 24 months
Title
Quadriceps strength
Description
Isokinetic quadriceps strength will be assessed with a Biodex
Time Frame
Change in quadriceps strength from baseline to 24 months.
Title
Timed Physical Function tasks
Description
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.
Time Frame
Change in timed physical function task over 24 months
Title
Exercise quality
Description
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.
Time Frame
Average measure of exercise quality over 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Baker, PhD
Organizational Affiliation
Boston University Charles River Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31074576
Citation
Baker K, LaValley MP, Brown C, Felson DT, Ledingham A, Keysor JJ. Efficacy of Computer-Based Telephone Counseling on Long-Term Adherence to Strength Training in Elderly Patients With Knee Osteoarthritis: A Randomized Trial. Arthritis Care Res (Hoboken). 2020 Jul;72(7):982-990. doi: 10.1002/acr.23921.
Results Reference
derived
PubMed Identifier
29361920
Citation
Chang FH, Jette AM, Slavin MD, Baker K, Ni P, Keysor JJ. Detecting functional change in response to exercise in knee osteoarthritis: a comparison of two computerized adaptive tests. BMC Musculoskelet Disord. 2018 Jan 23;19(1):29. doi: 10.1186/s12891-018-1942-9.
Results Reference
derived
Links:
URL
http://www.bu.edu/enact/
Description
The ENACT Center at Boston University's Sargent College of Health and Rehabilitation Sciences.

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

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