NCT01647243

Brief Summary

The purpose of this study is to investigate if preoperative strength training will result in faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

July 13, 2012

Last Update Submit

July 20, 2012

Conditions

Osteoarthritis, Knee

Keywords

Knee osteoarthritisTotal knee arthroplastyPreoperative trainingStrength training

Outcome Measures

Primary Outcomes (1)

  • Primary outcome: Sit-to-stand test

    Ability of function test

    Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative

Secondary Outcomes (15)

  • Isokinetic: Quadriceps 60 gr./sek

    6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation

  • Isokinetic: Hamstrings 60 gr./sek

    6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation

  • Isometric: Quadriceps (70 gr. flexion)

    6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation

  • Isometric: Hamstrings (20 gr. flexion)

    6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation

  • Rate of force development (flexion and extension)

    6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation

  • +10 more secondary outcomes

Study Arms (2)

Preoperative strength training

EXPERIMENTAL

Progressive strength training on group basis four weeks before the operation and progressive strength training on group basis four weeks after the operation

Other: Preoperative strength training

Living as usual

NO INTERVENTION

The patients are living as usual the last 4 weeks before operation

Interventions

Preoperative strength trainingOTHER

Progressive strength training on group basis (not more than 3 subjects) 3 sessions weekly starting 4 weeks before the operation, in total 12 sessions Strength training 3 sessions weekly 4 weeks postsurgery

Also known as: Strength training, Preoperative training
Preoperative strength training

Eligibility Criteria

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

You may qualify if:

  • Planned TKA at the Aarhus University Hospital or Region Hospital Silkeborg,
  • Living in Aarhus Municipality,
  • Primary knee osteoarthritis or secondary osteoarthritis after meniscectomy or ligament injury

You may not qualify if:

  • Unstable blood pressure,
  • Neuromuscular or neurodegenerative disease,
  • Comprehension or dementia problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University hospital

Aarhus, 8000, Denmark

RECRUITING

Related Publications (2)

  • Skoffer B, Dalgas U, Maribo T, Soballe K, Mechlenburg I. No Exacerbation of Knee Joint Pain and Effusion Following Preoperative Progressive Resistance Training in Patients Scheduled for Total Knee Arthroplasty: Secondary Analyses From a Randomized Controlled Trial. PM R. 2018 Jul;10(7):687-692. doi: 10.1016/j.pmrj.2017.11.002. Epub 2017 Nov 9.

    PMID: 29129608DERIVED

  • Skoffer B, Maribo T, Mechlenburg I, Hansen PM, Soballe K, Dalgas U. Efficacy of Preoperative Progressive Resistance Training on Postoperative Outcomes in Patients Undergoing Total Knee Arthroplasty. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1239-51. doi: 10.1002/acr.22825. Epub 2016 Jul 28.

    PMID: 26713665DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kjeld Soeballe, Professor

    Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C

    STUDY CHAIR

Central Study Contacts

Birgit Sørensen Skoffer, MPH

CONTACT

+45 50 42 28 30BSkoffer@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 23, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

DK(1)