Functional Movement Retraining After Hip Replacement

NCT ID: NCT01878175

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-12-31

Brief 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.

Detailed 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.

Conditions

Arthroplasty, Replacement, Hip

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Functional Movement Retraining

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelli Dominick Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Duke University Medical Center

Durham, North Carolina, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

Other Identifiers

O1033-P

Identifier Type: -

Identifier Source: org_study_id