Clinical trial NCT01817010: Strength and Function Following Total Hip Arthroplasty
Official title: Strength and Function Following Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Total Hip Arthroplasty
Muscle Strength
Hip Osteoarthritis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Stair Climbing Time
timeFrame: preoperatively and post operatively at 6, 10, 18 and 28 weeks
Secondary outcomes:
measure: Functional Performance Tests
timeFrame: preoperatively and post operatively at 6, 10, 18 and 28 weeks
measure: Isometric Muscle Strength
timeFrame: preoperatively and post operatively at 6, 10, 18 and 28 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Stevens-Lapsley, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References: