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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03227120 |
Recruitment Status :
Completed
First Posted : July 24, 2017
Last Update Posted : August 7, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthroplasty Osteoarthritis, Knee | Other: Prehabilitation exercise | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | December 31, 2019 |
Actual Study Completion Date : | July 31, 2020 |

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.
|
- 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

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.
Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, Virginia | |
Institute for Orthopaedics and Neurosciences | |
Roanoke, Virginia, United States, 24014 |
Principal Investigator: | William H Kolb, DPT | Radford University |
Publications:
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 7, 2020 |
Last Verified: | August 2020 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Exercise Therapy |
Osteoarthritis, Knee Osteoarthritis Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |