Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

NCT ID: NCT01003756

Last Updated: 2012-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Knee Intervention

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

Group Type EXPERIMENTAL

Preoperative neuromuscular exercise

Intervention Type 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

Knee Control

Patients undergoing Total Knee Replacement. Receives standard instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Hip Intervention

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

Group Type EXPERIMENTAL

Preoperative neuromuscular exercise

Intervention Type 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

Hip Control

Patients undergoing Total Hip Replacement. Receives standard instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Allan Villadsen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ewa Roos, Professor, PT, PhD

Role: STUDY_CHAIR

University of Southern Denmark

Allan Villadsen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Dept. of Orthopedics Svendborg Community Hospital

Svendborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 28061841 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24931956 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23661494 (View on PubMed)

Other Identifiers

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s-20090099

Identifier Type: -

Identifier Source: org_study_id

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