Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT01877733

Collaborator

St. Olavs Hospital (Other), Helse Nord-Trøndelag HF (Other)

Enrollment

Location

Arms

29.9

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant.

Furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase.

The study is a randomized controlled trial. The investigators hypothesize that MST will increase muscle strength and physical function more than standard rehabilitation.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Other: Maximal strength training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maximal strenght training Training maximal strength training 3 times a week/1 physiotherapy session for 8 weeks	Other: Maximal strength training
No Intervention: Standard rehabilitation 2-3 physiotherapy sessions a week for 8 weeks/telephone contact by project leader once a week/writing training diary

Arm

Intervention/Treatment

Experimental: Maximal strenght training

Training maximal strength training 3 times a week/1 physiotherapy session for 8 weeks

Other: Maximal strength training

No Intervention: Standard rehabilitation

2-3 physiotherapy sessions a week for 8 weeks/telephone contact by project leader once a week/writing training diary

Outcome Measures

Primary Outcome Measures

Muscle strength in leg extension and leg press [Measured preoperatively, after 7 days, 10 wks and 1 year]
Measured preoperatively implies measuring the outcome within the last month prior to surgery

Secondary Outcome Measures

6 minute walk test [preopertively, 7 days postoperatively and after 1 year]
Measuring the outcome preoperatively implies testing within the last month prior to surgery
KOOS; Knee injury and osteosarthritis outcome score [Preoperatively (within 1 month prior to surgery), 7 days postoperatively and 10 wks and 1 year postoperatively]
EQ-5D (measure of health outcome) [Preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively]
VAS scale recording pain [preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

unilateral osteoarthritis,
< 75 years

Exclusion Criteria:

disease(s) that compromise testing/training,
unable to understand written and verbal instructions and information,
osteoarthritis in the contralateral leg that needs treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Olavs hospital	Trondheim		Norway	7006

Sponsors and Collaborators

Norwegian University of Science and Technology
St. Olavs Hospital
Helse Nord-Trøndelag HF

Investigators

Principal Investigator: Vigdis S Husby, PhD, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01877733

Other Study ID Numbers:

2012/1678

First Posted:

Jun 14, 2013

Last Update Posted:

Apr 22, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Norwegian University of Science and Technology

Resistance training

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of Apr 22, 2020