NCT01877733

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

April 16, 2013

Last Update Submit

April 20, 2020

Conditions

Keywords

Resistance training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 6 minute walk test

    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

Study Arms (2)

Maximal strenght training

EXPERIMENTAL

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

Other: Maximal strength training

Standard rehabilitation

NO INTERVENTION

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

Interventions

Maximal strenght training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral osteoarthritis,
  • \< 75 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs hospital

Trondheim, 7006, Norway

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Vigdis S Husby, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2013

First Posted

June 14, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations