Strength and Function Following Total Hip Arthroplasty

To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation program (CMC) have better strength and functional performance compared to a control group (CON).

The investigators hypothesize that functional performance and strength in the muscles surrounding the hip and the knee will be greater in the multi-component rehabilitation group compared to the control group.

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Behavioral: Control (CON); Behavioral: Multi-Component Rehabilitation (CMC)

Detailed Description

The participants will be enrolled and following surgery, randomized into one of two treatment groups (CMC or CON). Prior to randomization, both groups will participate in two weeks of home rehabilitation consisting mobility training and activities of daily living. After randomization, the CMC group will receive physical therapy 2x/ week for 8 weeks from a licensed physical therapist and member of the investigative team starting 2 weeks after Total Hip Arthroplasty (THA). The CON group will continue activities provided by their home rehabilitation therapist for 8 weeks. The CON group will then participate in the CMC intervention beginning 10 weeks after THA. These patients will complete pre-operative and post-operative testing as described above.

The CMC group will receive a multi-component program focused on rehabilitation of the abdominal and core musculature, neuromuscular re-education through therapeutic exercise as well as hip and knee muscle strengthening beginning 2 weeks after THA. The CON group will participate in physical therapist recommended activities based on their home rehabilitation and then will complete the same multi-component rehabilitation intervention beginning 10 weeks after THA.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver, Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• receiving a total hip replacement secondary to MD diagnosed end-state osteoarthritis only
• cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study.

Exclusion Criteria:

• HbA1c levels greater than 7% based on medical records
• neurological, vascular or cardiac problems that limit function
• moderate or severe osteoarthritis or other orthopaedic conditions in the non-operated lower extremity
• lower back pain which interferes with activities of daily living
• diagnosed disease which affects muscle function (Parkinson's, Fibromyalgia, Multiple Sclerosis)
• history of vestibular dysfunction
• body mass index greater than 40
• alcoholism or drug abuse

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: Multi-Component Rehabilitation (CMC); The CMC group will receive a multi-component program focused on rehabilitation of the abdominal and core musculature, neuromuscular re-education through therapeutic exercise as well as hip and knee muscle strengthening beginning 2 weeks after THA.	Behavioral: Multi-Component Rehabilitation (CMC)
Active Comparator: Control (CON); The CON group will participate in physical therapist recommended activities based on their home rehabilitation and then will complete the same CMC rehabilitation intervention beginning 10 weeks after THA.	Behavioral: Control (CON)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stair Climbing Time	Time to ascend and descend 12 stairs.	preoperatively and post operatively at 6, 10, 18 and 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Performance Tests	Health status and activity questionnaires (SF-36, WOMAC, UCLA score), timed up and go test, sit to stand performance, 6 minute walk test, timed Single Leg balance on variable surfaces, Fullerton Assessment of Balance and the modified Trendelenburg test	preoperatively and post operatively at 6, 10, 18 and 28 weeks
Isometric Muscle Strength	Isometric strength of the hip flexors, extensors, abductors and knee extensors and flexors.	preoperatively and post operatively at 6, 10, 18 and 28 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jennifer Stevens-Lapsley, PT,PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 22, 2013

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Hip Osteoarthritis; Muscle Strength; Total Hip Arthroplasty
• Other Study ID Numbers: 09-1121