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OpenTrials
Completed

NCT Number: NCT01817010

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-Component Rehabilitation (CMC)

Behavioral

Control (CON)

Behavioral

Primary outcomes

  1. Stair Climbing Time

    Time frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks

    Time to ascend and descend 12 stairs.

Secondary outcomes

  1. Functional Performance Tests

    Time frame: 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

  2. Isometric Muscle Strength

    Time frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks

    Isometric strength of the hip flexors, extensors, abductors and knee extensors and flexors.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2013
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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