Completed

Strength and Function Following Total Hip Arthroplasty

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What is being tested

Multi-Component Rehabilitation (CMC)

+ Control (CON)

Behavioral
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

From 50 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: July 11, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Colorado, Denver
Last updated: July 11, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Hip

Criteria

2 inclusion criteria required to participate
cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

receiving a total hip replacement secondary to MD diagnosed end-state osteoarthritis only

8 exclusion criteria prevent from participating
HbA1c levels greater than 7% based on medical records

alcoholism or drug abuse

body mass index greater than 40

diagnosed disease which affects muscle function (Parkinson's, Fibromyalgia, Multiple Sclerosis)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Colorado Denver, Anschutz Medical Campus

Aurora, United StatesOpen University of Colorado Denver, Anschutz Medical Campus in Google Maps
CompletedOne Study Center