Strength and Function Following Total Hip Arthroplasty
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 11, 2016
July 1, 2016
3.2 years
March 20, 2013
July 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stair Climbing Time
Time to ascend and descend 12 stairs.
preoperatively and post operatively at 6, 10, 18 and 28 weeks
Secondary Outcomes (2)
Functional Performance Tests
preoperatively and post operatively at 6, 10, 18 and 28 weeks
Isometric Muscle Strength
preoperatively and post operatively at 6, 10, 18 and 28 weeks
Study Arms (2)
Multi-Component Rehabilitation (CMC)
EXPERIMENTALThe 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.
Control (CON)
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Stevens-Lapsley, PT,PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 22, 2013
Study Start
September 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 11, 2016
Record last verified: 2016-07