NCT01394874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2016

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

4.5 years

First QC Date

June 21, 2011

Last Update Submit

January 15, 2019

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritisexercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 24 -month change in self-report of pain and function using the WOMAC index

    post the 1-month exercise class, 24 months

  • Quadriceps strength

    Change in quadriceps strength from baseline to 24 months.

  • Timed Physical Function tasks

    Change in timed physical function task over 24 months

  • Exercise quality

    Average measure of exercise quality over 24 months

Study Arms (2)

Telephone-linked Communication (TLC)

EXPERIMENTAL

This group will receive the computer-based telephone counseling.

Behavioral: TLC

Control

NO INTERVENTION

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

Interventions

TLCBEHAVIORAL

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

Telephone-linked Communication (TLC)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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.

    PMID: 31074576DERIVED

  • 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.

    PMID: 29361920DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Kristin Baker, PhD

    Boston University Charles River Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

July 15, 2011

Study Start

July 1, 2011

Primary Completion

January 15, 2016

Study Completion

January 15, 2016

Last Updated

January 17, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)