NCT01808781

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

March 6, 2013

Last Update Submit

October 11, 2017

Conditions

Keywords

Powermuscle strengthtotal knee replacementphysical activity behavior

Outcome Measures

Primary Outcomes (1)

  • Muscle Power

    Change in quadriceps muscle power (force versus velocity)

    Baseline and 8 weeks

Secondary Outcomes (1)

  • muscle strength

    Baseline and 8 weeks

Other Outcomes (2)

  • Functional Performance

    Baseline and 8 weeks

  • Physical activity behavior

    Baseline and 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Home exercise program plus walking program during 8-week period

Other: Exercises plus walking program

Comparison group

ACTIVE COMPARATOR

Walking only program throughout the 8-week period.

Other: Walking only program

Interventions

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.

Intervention group

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.

Comparison group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235-7299, United States

Location

Related Publications (1)

  • Trudelle-Jackson E, Hines E, Medley A, Thompson M. Exploration of Habitual Walking Behavior and Home-Based Muscle Power Training in Individuals With Total Knee Arthroplasty. J Phys Act Health. 2020 Mar 1;17(3):331-338. doi: 10.1123/jpah.2019-0233.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emerenciana S Hines, PhD

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 11, 2013

Study Start

March 1, 2013

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

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

Locations