Strength and Function Following Total Hip Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01817010
First received: March 20, 2013
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Total Hip Arthroplasty
Behavioral: Multi-Component Rehabilitation (CMC)
Behavioral: Control (CON)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strength and Function Following Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Stair Climbing Time [ Time Frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks ] [ Designated as safety issue: No ]
    Time to ascend and descend 12 stairs.


Secondary Outcome Measures:
  • Functional Performance Tests [ Time Frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: preoperatively and post operatively at 6, 10, 18 and 28 weeks ] [ Designated as safety issue: No ]
    Isometric strength of the hip flexors, extensors, abductors and knee extensors and flexors.


Estimated Enrollment: 36
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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 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 Total Hip Arthroplasty (THA).

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817010

Locations
United States, Colorado
University of Colorado Denver, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer Stevens-Lapsley, PT, PhD    303-724-9590    jennifer.stevens-lapsley@ucdenver.edu   
Principal Investigator: Jennifer E Stevens-Lapsley, PT, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jennifer Stevens-Lapsley, PT,PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01817010     History of Changes
Other Study ID Numbers: 09-1121
Study First Received: March 20, 2013
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Total Hip Arthroplasty
Muscle Strength
Hip Osteoarthritis

ClinicalTrials.gov processed this record on September 30, 2014