Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, hip
Treatment functional movement retraining
Sponsor VA Office of Research and Development
Collaborator Duke University
Start date May 2014
End date September 2015
Trial size 15 participants
Trial identifier NCT01878175, O1033-P

Summary

Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often used to treat hip osteoarthritis, which is more common among Veterans than the general population. Some patients continue to experience functional limitations after THA, and studies have shown that these patients still tend to put greater loads on the opposite leg, which can increase the risk of developing osteoarthritis in that leg. One likely reason for these post-surgical limitations is that rehabilitation is very minimal following this procedure. This project will involve development and preliminary testing of a functional movement retraining program, designed to help Veterans improve their function and biomechanics after THA. The project will also develop processes for delivering this program in Veterans' homes, to increase accessibility.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
functional movement retraining
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).

Primary Outcomes

Measure
Change in Hip disability and osteoarthritis outcomes score (HOOS)
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

Secondary Outcomes

Measure
Change in Satisfaction with physical function questionnaire
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Global assessment of hip symptom change
time frame: 15 weeks (post-intervention)
Change in Objective functional test: Timed get up-and-go
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective functional test: Sit to stand
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective functional test: Walking speed
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective functional test: Stair climbing
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in University of California Los Angeles (UCLA) activity questionnaire
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Harris hip score (HHS)
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Lower quarter Y-balance test (YBT-LQ)
time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: - Veteran, Scheduled for hip arthroplasty at Durham, NC VA Medical Center Exclusion Criteria: - Dementia or other significant cognitive impairment; - movement or motor neuron disorders (e.g., Parkinson's Disease, post-stroke neurological deficiencies); - rheumatoid arthritis, - fibromyalgia, - or other systemic rheumatic disease; - hospitalization for a stroke, - myocardial infarction, - heart failure, - or coronary artery revascularization in the past 3 months; - psychosis or current, uncontrolled substance abuse disorder; - any other health conditions determined by the study team to be contraindications to performing the exercise program (e.g., mild home exercises); - transportation or other limitations that would prevent visits to the Durham VAMC for the retraining program.

Additional Information

Official title Functional Movement Retraining After Hip Arthroplasty in Veterans: Pilot Study
Principal investigator Kelli Dominick Allen, PhD
Description Rehabilitation following total hip arthroplasty (THA) is limited in scope, and some patients continue to exhibit functional limitations, as well as loading asymmetries that place them at risk for developing osteoarthritis in contralateral joints. The purpose of this study is to collect preliminary data to support a larger project that will examine the effectiveness of a 12-session functional movement retraining (FMR) program for Veterans following THA. A novel aspect of the FMR program is that it focuses not only on improving overall function but also normalizing side-to-side asymmetries in balance and strength via patient-specific tailoring of exercises. The program also involves telerehabilitation processes to improve access. Participants will be n=15 patients scheduled for THA at the Durham VAMC, identified from electronic medical records. Participants will complete assessments pre-operatively, then approximately 6-weeks post-THA, at which time FMR program will begin. The 12 FMR sessions will optimally be delivered twice weekly for 6 weeks. However, to account for missed visits, the investigators will allow for 9 total weeks to complete the 12 sessions. Therefore follow-up assessments will be scheduled at 15-weeks post-THA for all participants. FMR sessions will be a combination of: 1.) in-person, on-site visits and telephone contacts with a licensed physical therapist and 2.) in-home telehealth visits by a telehealth technologist or physical therapy assistant. The FMR program will focus on improving lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform a series of stretching exercises daily and strengthening exercises three times weekly. Exercises for each patient will be tailored according to results of the Lower Quarter Y-Balance Test (conducted at baseline and mid-way through the program), which assesses asymmetries between limbs and between anterior vs. posterior reach. Outcomes will include objective functional measures (timed up-and-go, sit-to-stand, walking speed, stair climb, Lower Quarter Y-Balance Test), self-reported pain and activity limitations (Hip disability and Osteoarthritis Outcome Score), and therapist-assessed function (Harris Hip Score). Basic descriptive statistics will be used to compare changes in each outcome (pre-operative to 15-week post-THA and 6-week post THA to 15-week post-THA) and inform sample size estimates for a larger trial. The investigators will also assess various aspects of program feasibility (recruitment success, adherence, telerehabilitation processes) and collect in-depth qualitative information from both patients and therapists to assess aspects of the intervention that may need to be modified prior to a larger study.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.