NCT03160534

Brief Summary

This study evaluates the effect of preoperative exercise in patients undergoing a total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

May 18, 2017

Last Update Submit

October 19, 2017

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Stair climbing test

    The stair climbing test (SCT) measures the time used to ascend and descend a flight of twelve steps. Patients are asked to complete the test as quickly as they felt safe and comfortable.

    5 minutes

Secondary Outcomes (4)

  • Knee - Range of Motion

    2 minutes

  • Tegner Activity Scale and Lysholm Score

    10 minutes

  • Patient Global Impression of Change

    2 minutes

  • Risk of Discharge to a Rehabilitation Facility

    20 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

Preoperative exercise intervention

Other: preoperative exercise

Control

NO INTERVENTION

Only measurements

Interventions

preoperative exerciseOTHER

Each intervention session contains a stretching part and aerobic training

Intervention

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing a Total Knee Arthroplasty
  • Signed informed consent after being informed

You may not qualify if:

  • Acute pain
  • Weakness due to neurological problems
  • Known or suspected non-compliance
  • High BMI \> 28
  • Patellar residual subluxation
  • High patellar height

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Granicher P, Stoggl T, Fucentese SF, Adelsberger R, Swanenburg J. Preoperative exercise in patients undergoing total knee arthroplasty: a pilot randomized controlled trial. Arch Physiother. 2020 Aug 5;10:13. doi: 10.1186/s40945-020-00085-9. eCollection 2020.

    PMID: 32774889DERIVED

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jaap Swanenburg, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Controlled Pilot Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 19, 2017

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

October 23, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

no there is not

Locations

CH(1)