Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

This study has been completed.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Allan Villadsen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01003756
First received: October 28, 2009
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in collaboration with University of Southern Denmark and Odense University Hospital.

The overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical function, pain and Quality of Life in patients undergoing total hip or knee replacement. Secondary area of interest is physical performance, muscle function, and level of physical activity.

The project will be conducted in two phases:

  • A pilot project focusing on the logistics of the upcoming randomized controlled trial (RCT) and determination of test-retest reliability of specific muscle strength variables for the patients of interest
  • A randomized and controlled trial where the intervention is preoperative neuromuscular exercise and the controls receive standard instructions.

Condition Intervention
Osteoarthritis
Other: Preoperative neuromuscular exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function [ Time Frame: 3 month postoperative (primary endpoint) ] [ Designated as safety issue: No ]
    Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up


Secondary Outcome Measures:
  • Self reported pain. Assessed with KOOS and HOOS subscale on pain. [ Time Frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up ] [ Designated as safety issue: No ]
  • Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life [ Time Frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up ] [ Designated as safety issue: No ]
  • Self reported quality of life. Assessed with EQ5D questionnaire [ Time Frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up ] [ Designated as safety issue: No ]
  • Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec [ Time Frame: baseline, one week preop. and 3 month postop. ] [ Designated as safety issue: No ]
  • Muscle strength estimated as average muscle power for muscles of the hip and knee [ Time Frame: baseline, 1 week preop. and 3 month postop ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Knee Intervention
Patients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively
Other: Preoperative neuromuscular exercise
A neuromuscular exercise programme delivered 8-10 weeks preoperatively. The programme is developed in Lund, Sweden. A journal of this study is under peer-review
No Intervention: Knee Control
Patients undergoing Total Knee Replacement. Receives standard instructions
Experimental: Hip Intervention
Patient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively
Other: Preoperative neuromuscular exercise
A neuromuscular exercise programme delivered 8-10 weeks preoperatively. The programme is developed in Lund, Sweden. A journal of this study is under peer-review
No Intervention: Hip Control
Patients undergoing Total Hip Replacement. Receives standard instructions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective primary, unilateral total hip or knee replacement in Svendborg Community Hospital, Odense University Hospital, Denmark.
  • Patients with osteoarthritis
  • Age over 18

Exclusion Criteria:

  • Not being able to read and understand Danish.
  • Patients with co-morbidity diseases where a moderate level of physical exercise is contraindicated, e.g. severe heart disease and neurological deficits.
  • Patients unable to attend intervention.
  • Rheumatoid arthritis (RA). A history of or ongoing use of medication for RA or other inflammatory arthritis such as gold, methotrexate, plaquenil etc.
  • Lack of wish to participate or unwillingness to sign an informed consent.
  • Specific for hip patients: a history of severe sequelae due to congenital hip-dysplasia requiring specialized postoperative training. A history of femoral neck and trochanteric fracture.
  • Patients planned to have bilateral joint replacement within same procedure.
  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: NCT01003756

Locations
Denmark
Dept. of Orthopedics Svendborg Community Hospital
Svendborg, Denmark, 5700
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
Study Chair: Ewa Roos, Professor, PT, PhD University of Southern Denmark
Principal Investigator: Allan Villadsen, MD University of Southern Denmark
  More Information

No publications provided

Responsible Party: Allan Villadsen, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01003756     History of Changes
Other Study ID Numbers: s-20090099
Study First Received: October 28, 2009
Last Updated: February 6, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University of Southern Denmark:
Preoperative
Exercise
Joint Replacement
Hip
Knee

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

ClinicalTrials.gov processed this record on July 23, 2014