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Early Rehabilitation After Total Hip Replacement

This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
Collaborator:
Regionshospitalet Silkeborg
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01214954
First received: September 17, 2010
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis, Hip
 Other: Supervised progressive resistance training
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Rehabilitation After Toal Hip Replacement. -Effect of Supervised Progressive Resistance Training

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Leg extension power [ Time Frame: 10 weeks postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks postoperative ] [ Designated as safety issue: No ]
    Maximal walking speed measured over 20 m.

  • Sit-to-stand [ Time Frame: 10 weeks postoperative ] [ Designated as safety issue: No ]
    The maximal number of rises from a chair within 30 seconds

  • Stair test [ Time Frame: 10 weeks postoperative ] [ Designated as safety issue: No ]
    The time taken to ascend 18 steps as fast as possible

  • Hip Osteoarthritis Outcome Score (HOOS) [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.

  • Walking speed [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Maximal walking speed measured over 20 m.

  • Walking speed [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    Maximal walking speed measured over 20 m.

  • Leg extension power [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    The maximal number of rises from a chair within 30 seconds

  • Stair test [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    The time taken to ascend 18 steps as fast as possible

  • Hip Osteoarthritis Outcome Score (HOOS) [ Time Frame: 2 weeks postoperative ] [ Designated as safety issue: No ]
    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) [ Time Frame: 4 weeks postoperative ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks postoperative ] [ Designated as safety issue: No ]
    Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.

  • Isometric muscle strength [ Time Frame: 4 weeks postoperative ] [ Designated as safety issue: No ]
    Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry

  • Isometric muscle strength [ Time Frame: 10 weeks postoperative ] [ Designated as safety issue: No ]
    Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry

  • Isometric muscle strength [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry

  • Gait quality [ Time Frame: 10 weeks postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    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) [ Time Frame: 10 weeks postoperative ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 year postoperative ] [ Designated as safety issue: No ]
    Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.


Estimated Enrollment: 73
Study Start Date: September 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214954

Contacts
Contact: Lone R Mikkelsen, MSc. +45 78 41 76 13 lonemike@rm.dk

Locations
Denmark
Silkeborg Regional Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Lone R Mikkelsen, MSc.     +45 8722 2851     lonemike@rm.dk    
Principal Investigator: Lone R Mikkelsen, MSc.            
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Silkeborg
Investigators
Principal Investigator: Lone R Mikkelsen, MSc. University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01214954     History of Changes
Other Study ID Numbers: M-20090231
Study First Received: September 17, 2010
Last Updated: September 10, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Total Hip Replacement
Rehabilitation
Resistance training

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013