- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160534
Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty
October 19, 2017 updated by: Balgrist University Hospital
Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Pilot Trial
This study evaluates the effect of preoperative exercise in patients undergoing a total knee arthroplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objectives of this study were to investigate the effects of a single (9 sessions) prescription community based preoperative physical therapy in patients awaiting a Total Knee Arthroplasty, taking prognostic factors into account.
The investigators will use different outcome measures to evaluate any possible effects.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8008
- Balgrist University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing a Total Knee Arthroplasty
- Signed informed consent after being informed
Exclusion Criteria:
- Acute pain
- Weakness due to neurological problems
- Known or suspected non-compliance
- High BMI > 28
- Patellar residual subluxation
- High patellar height
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Preoperative exercise intervention
|
Each intervention session contains a stretching part and aerobic training
|
No Intervention: Control
Only measurements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stair climbing test
Time Frame: 5 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee - Range of Motion
Time Frame: 2 minutes
|
The range of motion of the knee will be assessed.
|
2 minutes
|
Tegner Activity Scale and Lysholm Score
Time Frame: 10 minutes
|
The Lysholm score and the Tegner activity scale are widely used for assessing knee function and activity level after knee ligament injuries
|
10 minutes
|
Patient Global Impression of Change
Time Frame: 2 minutes
|
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.
|
2 minutes
|
Risk of Discharge to a Rehabilitation Facility
Time Frame: 20 minutes
|
Costs and duration of postoperative rehabilitation will be measured with help of a personal calendar.
All participants will report on this calendar any post-acute care services after surgery, Costs of skilled nursing facilities, home health agencies, and inpatient rehabilitation.
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jaap Swanenburg, PhD, Balgrist University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
May 18, 2017
First Submitted That Met QC Criteria
May 18, 2017
First Posted (Actual)
May 19, 2017
Study Record Updates
Last Update Posted (Actual)
October 23, 2017
Last Update Submitted That Met QC Criteria
October 19, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2015-0472
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
no there is not
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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