Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Prehabilitative Exercise on Functional Recovery Following Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03227120
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Radford University
Information provided by (Responsible Party):
Carilion Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary aim of this study is to determine the effects of pre-surgery exercise known as Prehabilitation, on functional outcomes for patients following Total Knee Arthroplasty (TKA) surgery. The hypothesis is patients that receive effective pre-surgery prehabilitation will demonstrate improved recovery as measured by the 6-minute walk (6MW) test at one month post surgery.

Condition or disease Intervention/treatment Phase
Arthroplasty Osteoarthritis, Knee Other: Prehabilitation exercise Not Applicable

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • waiting on primary unilateral Total Knee Arthroplasty for knee osteoarthritis
  • agree to participate including completion of a guided exercise program three times per week for eight weeks

Exclusion Criteria:

  • current tobacco use,
  • body mass index (BMI) greater than 40 kg/m2,
  • pain present in the contralateral limb of 5/10 or more during stair climbing,
  • knee or hip replacement surgery in the previous year.
  • any medical conditions for which moderate or vigorous exercise is contraindicated. For example uncontrolled stage 2 or 3 hypertension risk group B or C (Pescatello 2004)
  • any disease that severely effects functional performance. For example Stroke or Parkinson's disease.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: William H Kolb, DPT (540) 577-0024 wkolb@radford.edu
Contact: Kathy Chalflinch, DNP (540) 853-0461 kfchalflinch@carilionclinic.org

Locations
Layout table for location information
United States, Virginia
Institute for Orthopaedics and Neurosciences Recruiting
Roanoke, Virginia, United States, 24014
Contact: Deborah F Joyce    540-588-0604    dfjoyce@carilionclinic.org   
Contact: April H Nichols, PTA    540-512-1005    AHNichols@carilionclinic.org   
Sponsors and Collaborators
Carilion Clinic
Radford University
Investigators
Layout table for investigator information
Principal Investigator: William H Kolb, DPT Radford University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Center for Disease Control numbers of joint replacements per year  This link exits the ClinicalTrials.gov site Center for Disease Control arthritis and comorbidity statistics  This link exits the ClinicalTrials.gov site

Publications:

Layout table for additonal information
Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT03227120    
Other Study ID Numbers: IRB#2242
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) will be de-identified. All IPD will only be available to members of the research team and stored on a Carilion password protected computer and protected drive. Any data for analysis will be de-identified and only the minimum required for analysis will be provided.
Supporting Materials: Study Protocol
Time Frame: December 2019 or 6 months after the final subject data has been recorded
Access Criteria: Data which have been de-identified will be shared only within the research team.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carilion Clinic:
Exercise Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Knee
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases