Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Maximal strength training

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • St. Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength in leg extension and leg press	Measured preoperatively implies measuring the outcome within the last month prior to surgery	Measured preoperatively, after 7 days, 10 wks and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	Measuring the outcome preoperatively implies testing within the last month prior to surgery	preopertively, 7 days postoperatively and after 1 year
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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Helse Nord-Trøndelag HF
• Investigators: Principal Investigator: Vigdis S Husby, PhD, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
• Husby VS, Foss OA, Husby OS, Winther SB. Randomized controlled trial of maximal strength training vs. standard rehabilitation following total knee arthroplasty. Eur J Phys Rehabil Med. 2018 Jun;54(3):371-379. doi: 10.23736/S1973-9087.17.04712-8. Epub 2017 Sep 13.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Resistance training
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2012/1678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No