The Effects of Prehabilitative Exercise on Functional Recovery Following Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03227120|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty Osteoarthritis, Knee||Other: Prehabilitation exercise||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized controlled trial with repeated measures pre and post-surgery. Consecutive patients which meet inclusion and exclusion criteria and consent to participate will be evaluated two months or more pre-operatively. After completion of office testing at the pre-surgery/pre-exercise time point, randomization will be completed using a gender stratified randomized sequence generated prior to subject recruitment.|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Prehabilitative Exercise on Functional Recovery Following Total Knee Arthroplasty|
|Actual Study Start Date :||July 5, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: Prehabilitation Exercise
Receives Prehabilitation exercise program for three times a week for eight weeks of direct outpatient exercise instruction.
Other: Prehabilitation exercise
Three times weekly exercise program of strengthening, balance and functional activities.
Weekly evaluation and progression with daily use of the Borg Rating of Perceived Exertion (RPE) supplemented with Heart Rate (HR) and Blood Pressure as needed to target the moderate intensity training level (40-60% HR Max) or above as appropriate to each individual.
No Intervention: Control
Receives the usual standard of care which is a one time Strength and Flexibility written home exercise program provided during total joint education pre-surgery class.
- Change of Six-minute walk test over time [ Time Frame: Six months: from baseline through completion of the study at approximately three months after surgery ]Assesses distance walked over six minutes at a preferred walking speed
- Change of Manual muscle tests of hip flexion, extension, abduction; knee flexion, extension and ankle dorsiflexion over time [ Time Frame: Average of six months: from baseline through completion of the study at approximately three months after surgery ]Standard muscle testing positions quantified using the MicroFET2
- Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) over time [ Time Frame: Average of six months: from baseline through completion of the study at approximately three months after surgery ]Self-reported outcome questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227120
|Contact: William H Kolb, DPT||(540) firstname.lastname@example.org|
|Contact: Kathy Chalflinch , DNP||(540) email@example.com|
|United States, Virginia|
|Institute for Orthopaedics and Neurosciences||Recruiting|
|Roanoke, Virginia, United States, 24014|
|Contact: Deborah F Joyce 540-588-0604 firstname.lastname@example.org|
|Contact: April H Nichols, PTA 540-512-1005 AHNichols@carilionclinic.org|
|Principal Investigator:||William H Kolb, DPT||Radford University|