Functional Movement Retraining After Hip Replacement

NCT01878175 | Completed Results

• 1 other identifier: O1033-P
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Arthroplasty, Replacement, Hip; Veterans; Exercise

Outcome Measures

Primary Outcomes (5)

• Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale

  The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

• Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale

  The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

• Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale

  The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

• Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale

  The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

• Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale

  The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

Secondary Outcomes (9)

• Change in Satisfaction With Physical Function Questionnaire

  Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)

• Global Assessment of Hip Symptom Change

  15 weeks (post-intervention)

• Change in Objective Functional Test: Timed Get Up-and-go

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

• Change in Objective Functional Test: Sit to Stand

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

• Change in Objective Functional Test: Walking Speed

  Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)

Study Arms (1)

Functional Movement Retraining

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).

Behavioral: Functional Movement Retraining

Interventions

Functional Movement Retraining 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).

Functional Movement Retraining

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Veteran, Scheduled for hip arthroplasty at Durham, NC VA Medical Center

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Duke University: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Kelli Allen
• Organization: Durham VA Medical Center

kelli.allen@va.gov

919-286-0411

Study Officials

• Kelli Dominick Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 14, 2013
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 28, 2017
• Results First Posted: February 28, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)