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Early Rehabilitation After Total Hip Replacement

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Supervised progressive resistance training
Control group
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Total Hip Replacement, Rehabilitation, Resistance training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Silkeborg Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Resistance training

Arm Description

Standard rehabilitation

10 weeks of supervised progressive resistance training initiated within the first week after total hip replacement.

Outcomes

Primary Outcome Measures

Leg extension power
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)

Secondary Outcome Measures

Walking speed
Maximal walking speed measured over 20 m.
Sit-to-stand
The maximal number of rises from a chair within 30 seconds
Stair test
The time taken to ascend 18 steps as fast as possible
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Walking speed
Maximal walking speed measured over 20 m.
Walking speed
Maximal walking speed measured over 20 m.
Leg extension power
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)
Sit-to-stand
The maximal number of rises from a chair within 30 seconds
Stair test
The time taken to ascend 18 steps as fast as possible
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Isometric muscle strength
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Isometric muscle strength
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Isometric muscle strength
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Gait quality
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)
Gait quality
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)
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.

Full Information

First Posted
September 17, 2010
Last Updated
November 21, 2013
Sponsor
University of Aarhus
Collaborators
Regionshospitalet Silkeborg
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1. Study Identification

Unique Protocol Identification Number
NCT01214954
Brief Title
Early Rehabilitation After Total Hip Replacement
Official Title
Early Rehabilitation After Toal Hip Replacement. -Effect of Supervised Progressive Resistance Training
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Regionshospitalet Silkeborg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Total Hip Replacement, Rehabilitation, Resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard rehabilitation
Arm Title
Resistance training
Arm Type
Experimental
Arm Description
10 weeks of supervised progressive resistance training initiated within the first week after total hip replacement.
Intervention Type
Other
Intervention Name(s)
Supervised progressive resistance training
Intervention Description
Resistance training 2 times/week initiated within the first week after total hip replacement. The training is supervised by physiotherapists and individually progressed.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Standard rehabilitation consisting of home-based exercises with 2 postoperative instructions by a physiotherapist.
Primary Outcome Measure Information:
Title
Leg extension power
Description
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)
Time Frame
10 weeks postoperative
Secondary Outcome Measure Information:
Title
Walking speed
Description
Maximal walking speed measured over 20 m.
Time Frame
4 weeks postoperative
Title
Sit-to-stand
Description
The maximal number of rises from a chair within 30 seconds
Time Frame
10 weeks postoperative
Title
Stair test
Description
The time taken to ascend 18 steps as fast as possible
Time Frame
10 weeks postoperative
Title
Hip Osteoarthritis Outcome Score (HOOS)
Description
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Time Frame
6 months postoperative
Title
Walking speed
Description
Maximal walking speed measured over 20 m.
Time Frame
10 weeks
Title
Walking speed
Description
Maximal walking speed measured over 20 m.
Time Frame
6 months postoperative
Title
Leg extension power
Description
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)
Time Frame
6 months postoperative
Title
Sit-to-stand
Description
The maximal number of rises from a chair within 30 seconds
Time Frame
6 months postoperative
Title
Stair test
Description
The time taken to ascend 18 steps as fast as possible
Time Frame
6 months postoperative
Title
Hip Osteoarthritis Outcome Score (HOOS)
Description
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Time Frame
2 weeks postoperative
Title
Hip Osteoarthritis Outcome Score (HOOS)
Description
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Time Frame
4 weeks postoperative
Title
Hip Osteoarthritis Outcome Score (HOOS)
Description
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Time Frame
6 weeks postoperative
Title
Isometric muscle strength
Description
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Time Frame
4 weeks postoperative
Title
Isometric muscle strength
Description
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Time Frame
10 weeks postoperative
Title
Isometric muscle strength
Description
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Time Frame
6 months postoperative
Title
Gait quality
Description
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)
Time Frame
10 weeks postoperative
Title
Gait quality
Description
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)
Time Frame
6 months postoperative
Title
Hip Osteoarthritis Outcome Score (HOOS)
Description
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Time Frame
10 weeks postoperative
Title
Hip Osteoarthritis Outcome Score (HOOS)
Description
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Time Frame
1 year postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lone R Mikkelsen, MSc.
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silkeborg Regional Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26851251
Citation
Mikkelsen LR, Petersen AK, Mechlenburg I, Mikkelsen S, Soballe K, Bandholm T. Description of load progression and pain response during progressive resistance training early after total hip arthroplasty: secondary analyses from a randomized controlled trial. Clin Rehabil. 2017 Jan;31(1):11-22. doi: 10.1177/0269215516628305. Epub 2016 Jul 10.
Results Reference
derived
PubMed Identifier
25305374
Citation
Mikkelsen LR, Mechlenburg I, Soballe K, Jorgensen LB, Mikkelsen S, Bandholm T, Petersen AK. Effect of early supervised progressive resistance training compared to unsupervised home-based exercise after fast-track total hip replacement applied to patients with preoperative functional limitations. A single-blinded randomised controlled trial. Osteoarthritis Cartilage. 2014 Dec;22(12):2051-8. doi: 10.1016/j.joca.2014.09.025. Epub 2014 Oct 22.
Results Reference
derived

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Early Rehabilitation After Total Hip Replacement

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