NCT01003756

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

October 28, 2009

Last Update Submit

February 6, 2012

Conditions

Osteoarthritis

Keywords

PreoperativeExerciseJoint ReplacementHipKnee

Outcome Measures

Primary Outcomes (1)

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

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

    3 month postoperative (primary endpoint)

Secondary Outcomes (5)

  • Self reported pain. Assessed with KOOS and HOOS subscale on pain.

    baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up

  • Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life

    baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up

  • Self reported quality of life. Assessed with EQ5D questionnaire

    baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up

  • Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec

    baseline, one week preop. and 3 month postop.

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

    baseline, 1 week preop. and 3 month postop

Study Arms (4)

Knee Intervention

EXPERIMENTAL

Patients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively

Other: Preoperative neuromuscular exercise

Knee Control

NO INTERVENTION

Patients undergoing Total Knee Replacement. Receives standard instructions

Hip Intervention

EXPERIMENTAL

Patient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively

Other: Preoperative neuromuscular exercise

Hip Control

NO INTERVENTION

Patients undergoing Total Hip Replacement. Receives standard instructions

Interventions

Preoperative neuromuscular exerciseOTHER

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

Hip InterventionKnee Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Orthopedics Svendborg Community Hospital

Svendborg, 5700, Denmark

Location

Related Publications (3)

  • Fernandes L, Roos EM, Overgaard S, Villadsen A, Sogaard R. Supervised neuromuscular exercise prior to hip and knee replacement: 12-month clinical effect and cost-utility analysis alongside a randomised controlled trial. BMC Musculoskelet Disord. 2017 Jan 6;18(1):5. doi: 10.1186/s12891-016-1369-0.

    PMID: 28061841DERIVED

  • Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15.

    PMID: 24931956DERIVED

  • Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014 Jun;73(6):1130-7. doi: 10.1136/annrheumdis-2012-203135. Epub 2013 May 9.

    PMID: 23661494DERIVED

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Ewa Roos, Professor, PT, PhD

    University of Southern Denmark

    STUDY CHAIR

  • Allan Villadsen, MD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

DK(1)