Skip to main content
OpenTrials
Completed

NCT Number: NCT01003756

Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Orthopedics Svendborg Community Hospital

Svendborg, 5700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative neuromuscular exercise

Other

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

Primary outcomes

  1. Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function

    Time frame: 3 month postoperative (primary endpoint)

    Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. Muscle strength estimated as average muscle power for muscles of the hip and knee

    Time frame: baseline, 1 week preop. and 3 month postop

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2009
Registry last updated
Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.