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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01808781
Other study ID # 17263
Secondary ID
Status Completed
Phase N/A
First received March 6, 2013
Last updated October 11, 2017
Start date March 2013
Est. completion date January 31, 2017

Study information

Verified date October 2017
Source Texas Woman's University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Texas Woman's University Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
Texas Woman's University Texas Physical Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Functional Performance 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
Other Physical activity behavior increase the number of steps per day and the minutes of moderate and/or vigorous physical activities. Baseline and 8 weeks
Primary Muscle Power Change in quadriceps muscle power (force versus velocity) Baseline and 8 weeks
Secondary muscle strength Change in quadriceps muscle strength. Baseline and 8 weeks
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