Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Rehabilitation After Total Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01214954
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Regionshospitalet Silkeborg
Information provided by (Responsible Party):
University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Other: Supervised progressive resistance training Other: Control group Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Rehabilitation After Toal Hip Replacement. -Effect of Supervised Progressive Resistance Training
Study Start Date : September 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Walking speed [ Time Frame: 4 weeks postoperative ]
    Maximal walking speed measured over 20 m.

  2. Sit-to-stand [ Time Frame: 10 weeks postoperative ]
    The maximal number of rises from a chair within 30 seconds

  3. Stair test [ Time Frame: 10 weeks postoperative ]
    The time taken to ascend 18 steps as fast as possible

  4. 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.

  5. Walking speed [ Time Frame: 10 weeks ]
    Maximal walking speed measured over 20 m.

  6. Walking speed [ Time Frame: 6 months postoperative ]
    Maximal walking speed measured over 20 m.

  7. 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)

  8. Sit-to-stand [ Time Frame: 6 months postoperative ]
    The maximal number of rises from a chair within 30 seconds

  9. Stair test [ Time Frame: 6 months postoperative ]
    The time taken to ascend 18 steps as fast as possible

  10. 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.

  11. 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.

  12. 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.

  13. Isometric muscle strength [ Time Frame: 4 weeks postoperative ]
    Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry

  14. Isometric muscle strength [ Time Frame: 10 weeks postoperative ]
    Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry

  15. Isometric muscle strength [ Time Frame: 6 months postoperative ]
    Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry

  16. 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)

  17. 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)

  18. 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.

  19. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214954


Locations
Layout table for location information
Denmark
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Silkeborg
Investigators
Layout table for investigator information
Principal Investigator: Lone R Mikkelsen, MSc. University of Aarhus
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01214954    
Other Study ID Numbers: M-20090231
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by University of Aarhus:
Total Hip Replacement
Rehabilitation
Resistance training
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Hip
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases