Early Rehabilitation After Total Hip Replacement

November 21, 2013 updated by: University of Aarhus

Early Rehabilitation After Toal Hip Replacement. -Effect of Supervised Progressive Resistance Training

The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After total hip replacement (THR) surgery there is a documented deficit in muscle strength and functional performance. There is a lack of evidence concerning the effectiveness of postoperative physiotherapy and training, however a few small studies have shown promising effect of resistance training.

The present study will provide new and important knowledge concerning the effect of different rehabilitation strategies after THR. This might lead to a change in the rehabilitation regimes and faster and better recovery after THR surgery.

Study Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Silkeborg, Denmark, 8600
        • Silkeborg Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Total hip replacement for osteoarthrosis
  • Living within 30 km from the hospital
  • Motivated to attend training 2 times/week in 10 weeks
  • Reduced functional ability measured as: HOOS score < 67
  • written informed consent

Exclusion Criteria:

  • Comorbidities such as cancer, neuromuscular diseases, heart diseases etc.
  • Cognitive impairment
  • Body mass index > 35
  • Resurfacing prosthesis
  • Scheduled additional prosthetic surgery in lower extremity within 6 months

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control group
Standard rehabilitation
Other: Control group
Standard rehabilitation consisting of home-based exercises with 2 postoperative instructions by a physiotherapist.
EXPERIMENTAL: Resistance training
10 weeks of supervised progressive resistance training initiated within the first week after total hip replacement.
Other: Supervised progressive resistance training
Resistance training 2 times/week initiated within the first week after total hip replacement. The training is supervised by physiotherapists and individually progressed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg extension power
Time Frame: 10 weeks postoperative
The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)
10 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: 4 weeks postoperative
Maximal walking speed measured over 20 m.
4 weeks postoperative
Sit-to-stand
Time Frame: 10 weeks postoperative
The maximal number of rises from a chair within 30 seconds
10 weeks postoperative
Stair test
Time Frame: 10 weeks postoperative
The time taken to ascend 18 steps as fast as possible
10 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time Frame: 6 months postoperative
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
6 months postoperative
Walking speed
Time Frame: 10 weeks
Maximal walking speed measured over 20 m.
10 weeks
Walking speed
Time Frame: 6 months postoperative
Maximal walking speed measured over 20 m.
6 months postoperative
Leg extension power
Time Frame: 6 months postoperative
The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)
6 months postoperative
Sit-to-stand
Time Frame: 6 months postoperative
The maximal number of rises from a chair within 30 seconds
6 months postoperative
Stair test
Time Frame: 6 months postoperative
The time taken to ascend 18 steps as fast as possible
6 months postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time Frame: 2 weeks postoperative
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
2 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time Frame: 4 weeks postoperative
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
4 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time Frame: 6 weeks postoperative
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
6 weeks postoperative
Isometric muscle strength
Time Frame: 4 weeks postoperative
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
4 weeks postoperative
Isometric muscle strength
Time Frame: 10 weeks postoperative
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
10 weeks postoperative
Isometric muscle strength
Time Frame: 6 months postoperative
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
6 months postoperative
Gait quality
Time Frame: 10 weeks postoperative
Instrumented gait analysis using a combined accelerometer and gyro-sensor in 20 meter walk test and stair climb test. The purpose is to measure asymmetry between limps during walking and stair climbing and compare the two groups according to these variables. This outcome measure is performed on a subgroup of participants (n=26, 13 in each group)
10 weeks postoperative
Gait quality
Time Frame: 6 months postoperative
Instrumented gait analysis using a combined accelerometer and gyro-sensor in 20 meter walk test and stair climb test. The purpose is to measure asymmetry between limps during walking and stair climbing and compare the two groups according to these variables. This outcome measure is performed on a subgroup of participants (n=26, 13 in each group)
6 months postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time Frame: 10 weeks postoperative
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
10 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time Frame: 1 year postoperative
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
1 year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Regionshospitalet Silkeborg

Investigators

  • Principal Investigator: Lone R Mikkelsen, MSc., University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

October 4, 2010

First Posted (ESTIMATE)

October 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20090231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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