Preoperative Resistance Training in Patients Scheduled for Total Hip Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Andreas Ebbe Bording Hermann, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01164111
First received: July 12, 2010
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

Purpose:

The purpose of this study is to determine the effect of pre operative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis.

Background:

Decreasing performance with age due to age related muscle loss is well known. Resistance training in elderly has shown significant effect in regaining both muscle force and function.

It has been shown that a chronic condition with limitations in function as seen in osteoarthritis of the hip decreases both muscle performance and size.

Studies of resistance training of the hip related muscle groups in the early postoperative period after total hip arthroplasty have shown significant effect on muscle force and function.

Few studies have investigated preoperative intervention, all with lighter types of training such as water pool training.

The effect of preoperative resistance training on subjects with primal osteoarthritis of the hip is yet to be described.

Study hypothesis:

Preoperative resistance training will significant improve outcomes on both primal and secondary effect parameters pre surgery and at 1 year followup.


Condition Intervention
Osteoarthritis
Hip Arthroplasty
Other: Preoperative resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Resistance Training in Patients Scheduled for Total Hip Arthroplasty - a Prospective Randomized Study in Patients With Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 0 weeks (entrypoint =T0) ] [ Designated as safety issue: No ]

    Questionnaire on Hip Dysfunktion.

    Rated questions on:

    • symptoms
    • stiffness
    • pain
    • function - daily living
    • function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 8 weeks (T1 pre surgery) ] [ Designated as safety issue: No ]

    Questionnaire on Hip Dysfunktion.

    Rated questions on:

    • symptoms
    • stiffness
    • pain
    • function - daily living
    • function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 3 months (T3 -post surgery) ] [ Designated as safety issue: No ]

    Questionnaire on Hip Dysfunktion.

    Rated questions on:

    • symptoms
    • stiffness
    • pain
    • function - daily living
    • function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 6 months (T4 - postsurgery) ] [ Designated as safety issue: No ]

    Questionnaire on Hip Dysfunktion.

    Rated questions on:

    • symptoms
    • stiffness
    • pain
    • function - daily living
    • function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 9 months (T5 -post surgery) ] [ Designated as safety issue: No ]

    Questionnaire on Hip Dysfunktion.

    Rated questions on:

    • symptoms
    • stiffness
    • pain
    • function - daily living
    • function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative

  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 12 months (endpoint - post surgery) ] [ Designated as safety issue: No ]

    Questionnaire on Hip Dysfunktion.

    Rated questions on:

    • symptoms
    • stiffness
    • pain
    • function - daily living
    • function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative


Secondary Outcome Measures:
  • Muscle Power [ Time Frame: 0 weeks (pre surgery) ] [ Designated as safety issue: No ]
    Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.

  • Muscle Power [ Time Frame: 0 weeks (pre surgery) ] [ Designated as safety issue: No ]
    Monoarticular measurement of muscle power. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.

  • Functional scores [ Time Frame: 0 weeks (pre surgery) ] [ Designated as safety issue: No ]

    Functional scores:

    Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand


  • Body composition: Dual Energy X-ray Absorptiometry scan(DEXA scan) [ Time Frame: 0 weeks (pre surgery ] [ Designated as safety issue: No ]

    DEXA:

    Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).


  • Activity score: Metabolic equivalent score (MET- score) [ Time Frame: 0 weeks (pre surgery) ] [ Designated as safety issue: No ]
    The MET score estimates the metabolic equivalent from an activity questionnaire.

  • Activity [ Time Frame: 0 weeks (pre surgery) ] [ Designated as safety issue: No ]

    Activity estmated by the sense wear pro3 armband. The armband is a validated device to estimate activity (energy expenditure)in adults.

    The armband will be worn i a period of 7 days at each time of control.


  • Muscle Power [ Time Frame: 8 weeks (pre surgery) ] [ Designated as safety issue: No ]
    Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.

  • Muscle Power [ Time Frame: 3 months (post surgery) ] [ Designated as safety issue: No ]
    Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.

  • Muscle Power [ Time Frame: 12 months (post surgery) ] [ Designated as safety issue: No ]
    Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.

  • Muscle Power [ Time Frame: 8 weeks (pre surgery) ] [ Designated as safety issue: No ]
    Monoarticular measurement of muscle power. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.

  • Muscle Power [ Time Frame: 3 months (post surgery) ] [ Designated as safety issue: No ]
    Monoarticular measurement of muscle power. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.

  • Muscle Power) [ Time Frame: 12 months (post surgery) ] [ Designated as safety issue: No ]
    Monoarticular measurement of muscle power. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.

  • Functional scores [ Time Frame: 8 weeks (pre surgery) ] [ Designated as safety issue: No ]
    Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand

  • Functional scores [ Time Frame: 3 months (post surgery) ] [ Designated as safety issue: No ]
    Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand

  • Functional scores [ Time Frame: 12 months (post surgery) ] [ Designated as safety issue: No ]
    Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand

  • Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan) [ Time Frame: 8 weeks (pre surgery) ] [ Designated as safety issue: No ]
    Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).

  • Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan) [ Time Frame: 3 months (post surgery) ] [ Designated as safety issue: No ]
    Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).

  • Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan) [ Time Frame: 12 months (post surgery) ] [ Designated as safety issue: No ]
    Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).

  • Activity score: Metabolic equivalent score (MET score) [ Time Frame: 8 weeks (pre surgery) ] [ Designated as safety issue: No ]
    The MET score estimates the metabolic equivalent from an activity questionnaire

  • Activity score: Metabolic equivalent score (MET score) [ Time Frame: 3 months (post surgery) ] [ Designated as safety issue: No ]
    The MET score estimates the metabolic equivalent from an activity questionnaire

  • Activity score: Metabolic equivalent score (MET score) [ Time Frame: 6 months (post surgery) ] [ Designated as safety issue: No ]
    The MET score estimates the metabolic equivalent from an activity questionnaire

  • Activity score: Metabolic equivalent score (MET score) [ Time Frame: 9 months (post surgery) ] [ Designated as safety issue: No ]
    The MET score estimates the metabolic equivalent from an activity questionnaire

  • Activity score: Metabolic equivalent score (MET score) [ Time Frame: 12 months (post surgery) ] [ Designated as safety issue: No ]
    The MET score estimates the metabolic equivalent from an activity questionnaire

  • Activity [ Time Frame: 8 weeks (pre surgery) ] [ Designated as safety issue: No ]

    Activity estmated by the sense wear pro3 armband. The armband is a validated device to estimate activity (energy expenditure)in adults.

    The armband will be worn i a period of 7 days at each time of control


  • Activity [ Time Frame: 3 months (post surgery) ] [ Designated as safety issue: No ]

    Activity estmated by the sense wear pro3 armband. The armband is a validated device to estimate activity (energy expenditure)in adults.

    The armband will be worn i a period of 7 days at each time of control


  • Activity [ Time Frame: 12 months (post surgery) ] [ Designated as safety issue: No ]

    Activity estmated by the sense wear pro3 armband. The armband is a validated device to estimate activity (energy expenditure)in adults.

    The armband will be worn i a period of 7 days at each time of control



Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preoperative resistance training
preoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise. Frequency: 2 times/week
Other: Preoperative resistance training
preoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise (stated as 8-10 repetitions of the exercise). Frequency: 2 times/week. The patient follows a special training program consisting of exercises with knee and hip extension. Training intensity is followed in a personalized log-book for each patient. Sessions are conducted in small teams closely supervised by specially trained physiotherapists.
No Intervention: Control
Standard preoperative track.: No training intervention. Standard preoperative information.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients scheduled for total hip arthroplasty due to primary osteoarthritis with an age of 50 years or older.
  • Patients in the intervention group must participate in 80% of the training as a minimum and more than 2 skipped sessions in a row is not allowed.

Exclusion Criteria:

  • Rheumatoid arthritis (RA) or other types of arthritis other than primary osteoarthritis.
  • Uremia
  • Cancer
  • Systemic treatment with glucocorticoid more than 3 months the last 5 years with a daily dose > 5 mg.
  • Fracture of the hip (ipsi or contralateral)
  • Other fracture of the lower extremities the last year
  • Other condition with reduced function (ex polio seq.)
  • Weight above 135 kg
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164111

Locations
Denmark
Ortopædkirurgisk Afdeling T Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
University of Southern Denmark
University of Copenhagen
Investigators
Principal Investigator: Andreas EB Hermann, MD University of Southern Denmark
  More Information

Publications:
Volpi E, Nazemi R, Fujita S. Muscle tissue changes with aging. Curr Opin Clin Nutr Metab Care; 2007; 7:405-410
Short KR, Nair KS. The effect of age on protein metabolism. Curr Opin Clin Nutr Metab Care. 2000 Jan;3(1):39-44

Responsible Party: Andreas Ebbe Bording Hermann, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01164111     History of Changes
Other Study ID Numbers: H-4-2010-034
Study First Received: July 12, 2010
Last Updated: March 27, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
osteoarthritis
hip arthroplasty
resistance training
preoperative training

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

ClinicalTrials.gov processed this record on August 28, 2014