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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01808781
First Posted: March 11, 2013
Last Update Posted: October 12, 2017
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.
Collaborator:
Texas Physical Therapy Association
Information provided by (Responsible Party):
Emerenciana Hines, Texas Woman's University
  Purpose

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.

Condition Intervention
Total Knee Arthroplasty Other: Exercises plus walking program Other: Walking only program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Emerenciana Hines, Texas Woman's University:

Primary Outcome Measures:
  • Muscle Power [ Time Frame: Baseline and 8 weeks ]
    Change in quadriceps muscle power (force versus velocity)


Secondary Outcome Measures:
  • muscle strength [ Time Frame: Baseline and 8 weeks ]
    Change in quadriceps muscle strength.


Other Outcome Measures:
  • 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.

  • 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.


Enrollment: 13
Actual Study Start Date: March 2013
Study Completion Date: January 31, 2017
Primary Completion Date: January 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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): NCT01808781


Locations
United States, Texas
Texas Woman's University
Dallas, Texas, United States, 75235-7299
Sponsors and Collaborators
Texas Woman's University
Texas Physical Therapy Association
Investigators
Principal Investigator: Emerenciana S Hines, PhD Texas Woman's University
  More Information

Responsible Party: Emerenciana Hines, PhD Student, Texas Woman's University
ClinicalTrials.gov Identifier: NCT01808781     History of Changes
Other Study ID Numbers: 17263
First Submitted: March 6, 2013
First Posted: March 11, 2013
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are planing to publish the results and sharing all the data with a journal interested in this study.

Keywords provided by Emerenciana Hines, Texas Woman's University:
Power
muscle strength
total knee replacement
physical activity behavior