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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Behavioral: TLC

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: Kristin Baker, PhD, Boston University Charles River Campus

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): January 15, 2016
• Study Completion (Actual): January 15, 2016

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: July 13, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; exercise
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: H133B100003-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO