Total Knee ArthroplastyTKRNCT01808781
The Effect of Home-based Velocity Training in Individuals With Total Knee Replacement
A study testing Exercises plus walking program and Walking only program in people with Total Knee Arthroplasty, run by Texas Woman's University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Exercises plus walking program and Walking only program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Exercises plus walking program, Walking only program
- Keywords
- Power, muscle strength, total knee replacement, physical activity behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises plus walking programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Home exercise program plus walking program during 8-week period Receives: Other: Exercises plus walking program |
| Comparison group | Active comparator | Walking only program throughout the 8-week period. Receives: Other: Walking only program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Power
Change in quadriceps muscle power (force versus velocity)
Measured: Baseline and 8 weeks
Secondary outcomes (1)
muscle strength
Change in quadriceps muscle strength.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startMar 2013
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Physical Therapy Association
- Responsible party
- Principal investigator, Emerenciana Hines, Texas Woman's University
- Investigators
- Emerenciana S Hines, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808781
- Sponsor's protocol ID
- 17263
- Acronym
- TKR
- Status last verified
- Oct 2017
- First submitted
- 6 Mar 2013
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We are planing to publish the results and sharing all the data with a journal interested in this study.
Publications
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.
PubMed 32023537
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01808781
- Acronym / sponsor ID
- TKR / 17263
- Conditions
- Total Knee Arthroplasty
- Keywords
- Power, muscle strength, total knee replacement, physical activity behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Texas Physical Therapy Association
- Study start
- Mar 2013 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Exercises plus walking programHome exercise program plus walking program during 8-week period |
| Comparison group | Active comparator | Other: Walking only programWalking only program throughout the 8-week period. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercises plus walking programExercise 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. | Other | Intervention group |
| Walking only programParticipants 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. | Other | Comparison group |
Primary outcome
Muscle Power
Time frame: Baseline and 8 weeks
Change in quadriceps muscle power (force versus velocity)
1 secondary outcome
muscle strength
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Derived from this study: PubMed 32023537Trudelle-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.
- Individual participant dataSharing planned: Yes. We are planing to publish the results and sharing all the data with a journal interested in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emerenciana S Hines, PhD principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises plus walking program and Walking only program in people with Total Knee Arthroplasty, run by Texas Woman's University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Power (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01808781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.