Strength and Function Following Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Total Hip Arthroplasty
• Interventions: Behavioral: Multi-Component Rehabilitation (CMC); Behavioral: Control (CON)

• Registration Number: NCT01817010
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-22
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-08
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-Component Rehabilitation (CMC)	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.
Control (CON)	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.

Primary Outcome Measures

Name	Time	Method
Stair Climbing Time	preoperatively and post operatively at 6, 10, 18 and 28 weeks	Time to ascend and descend 12 stairs.

Secondary Outcome Measures

Name	Time	Method
Functional Performance Tests	preoperatively and post operatively at 6, 10, 18 and 28 weeks	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
Isometric Muscle Strength	preoperatively and post operatively at 6, 10, 18 and 28 weeks	Isometric strength of the hip flexors, extensors, abductors and knee extensors and flexors.

Trial Locations

Locations (1)

University of Colorado Denver, Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States