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

NCT03227120 | Completed DMC

• 1 other identifier: IRB#2242
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty; Osteoarthritis, Knee

Keywords

Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• Change of Six-minute walk test over time

  Assesses distance walked over six minutes at a preferred walking speed

  Six months: from baseline through completion of the study at approximately three months after surgery

Secondary Outcomes (2)

• Change of Manual muscle tests of hip flexion, extension, abduction; knee flexion, extension and ankle dorsiflexion over time

  Average of six months: from baseline through completion of the study at approximately three months after surgery

• Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) over time

  Average of six months: from baseline through completion of the study at approximately three months after surgery

Study Arms (2)

Prehabilitation Exercise

EXPERIMENTAL

Receives Prehabilitation exercise program for three times a week for eight weeks of direct outpatient exercise instruction.

Other: Prehabilitation exercise

Control

NO INTERVENTION

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.

Interventions

Prehabilitation exercise OTHER

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.

Prehabilitation Exercise

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead
• Radford University: collaborator

Study Sites (1)

Institute for Orthopaedics and Neurosciences

Roanoke, Virginia, 24014, United States

Location

Related Publications (35)

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Related Links

• Center for Disease Control numbers of joint replacements per year

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William H Kolb, DPT

  Radford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: July 24, 2017
• Study Start: July 5, 2017
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)