The Effect of Home-based Velocity Training in Individuals With Total Knee Replacement (TKR)

October 11, 2017 updated by: Emerenciana Hines, Texas Woman's University

The Effect of Home-Based High-Velocity Training on Muscle Strength and Power, Functional Performance, and Physical Activity Behavior in Individuals With Total Knee Arthroplasty.

The purpose of this study will be to find out the effect of two different interventions on muscle strength, ability to produce muscle force quickly (power), daily function, and number of steps and physical activity an individual with total knee replacement do daily.

The research hypotheses for this study will be as follows:

  • For individuals who are at least 6 months post-total knee replacement, home-based high-velocity training exercises will result in significantly greater improvements in muscle strength and power compared to those who receive a walking program only.
  • For individuals who are at least 6 months post-total knee replacement, home based high-velocity training exercises will result in significantly greater improvements of daily function(eg. sit to stand, climb a set of stairs)than those who receive a walking program only.
  • For individuals who are at least 6 months post-total knee replacement, home based high-velocity training exercises will result in significantly greater improvements in physical activity behavior (eg. number of steps per day)compared to those who receive a walking program only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

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

  • United States
    • Texas
      • Dallas, Texas, United States, 75235-7299
        • Texas Woman's University

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women who are at least 40 years of age will qualify if they had a primary unilateral total knee replacement (TKR) 6 to 18 months.

Exclusion Criteria:

  • other lower extremity prosthetic implants other than the current TKR
  • revision TKR or plan for revision
  • diagnosis of severe osteoarthritis in the uninvolved knee or either hip joints
  • recent low extremity injury or significant pain that increases during weight bearing or other functional performance
  • diagnosis of neurologic deficits
  • decreased cognitive status that might affect the ability to follow instructions
  • significant cardiovascular and/or pulmonary disease that limits function

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Home exercise program plus walking program during 8-week period
Other: Exercises plus walking program
Exercise group Consist of functional exercises such as mini-squats, sit to stand, and exercises with use of thera-bands. For each exercise, participants will be taught to perform the concentric phase forcefully and as fast as they can and return to the initial position slowly and with control. Participants will be asked to perform the exercises 3 times per week as a home exercise program daily throughout the 8-week intervention period. Additionally, they will be asked to wear a pedometer daily throughout the 8-week intervention to monitor steps. A step goal will be provided to gradually increase daily to become "somewhat active" or "active" by the end of the 8-week intervention.
Active Comparator: Comparison group
Walking only program throughout the 8-week period.
Other: Walking only program
Participants will be asked to wear a pedometer and instructions for use just as the exercise group. They will also will given a step goal just as the participants in the exercise group and will similarly be asked to record number of steps form their pedometer in a daily log along with the minutes of moderate and vigorous physical activity throughout the 8-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Power
Time Frame: Baseline and 8 weeks
Change in quadriceps muscle power (force versus velocity)
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strength
Time Frame: Baseline and 8 weeks
Change in quadriceps muscle strength.
Baseline and 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Performance
Time Frame: Baseline and 8 weeks
Change the ability to perform the stair climb test faster and walking a further distance during the 6 minute walking test.
Baseline and 8 weeks
Physical activity behavior
Time Frame: Baseline and 8 weeks
increase the number of steps per day and the minutes of moderate and/or vigorous physical activities.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Collaborators

Texas Physical Therapy Association

Investigators

  • Principal Investigator: Emerenciana S Hines, PhD, Texas Woman's University

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.

General Publications

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)

March 1, 2013

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are planing to publish the results and sharing all the data with a journal interested in this study.

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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