Strength and Function Following Total Hip Arthroplasty

NCT ID: NCT01817010

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Multi-Component Rehabilitation (CMC)

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Control (CON)

Intervention Type BEHAVIORAL

Interventions

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Multi-Component Rehabilitation (CMC)

Intervention Type BEHAVIORAL

Control (CON)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Stevens-Lapsley, PT,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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09-1121

Identifier Type: -

Identifier Source: org_study_id

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