Strength and Function Following Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:

Strength and Function Following Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817010
• Other study ID #: 09-1121
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: July 8, 2016
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Behavioral:
• Multi-Component Rehabilitation (CMC)

• Control (CON)

Locations

Country	Name	City	State
United States	University of Colorado Denver, Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stair Climbing Time	Time to ascend and descend 12 stairs.	preoperatively and post operatively at 6, 10, 18 and 28 weeks	No
Secondary	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	No
Secondary	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	No