Total Knee ArthroplastyNCT01844934
Impact of Prehabilitation in Total Knee Replacement
A study testing Prehabilitation in people with Total Knee Arthroplasty, run by Allina Health System at 1 site in United States.
Trial summary
A study comparing the benefits of pre-habilitation exercise to standard care prior to total knee arthroplasy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2014to 1 Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo unilateral TKA surgery
- Ambulatory
- Community dwelling (living at home)
- Able to participate in moderate intensity exercise
- American Society of Anesthesiologists Physical Status Classification(ASA) 1 - 3
- Speaks English
Who cannot join
- Patients who are planning a second surgery of the lower limbs during the six months post-surgery
- Have the effect of peripheral vascular disease or stroke on walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Prehabilitation in Total Knee Arthroplasty: Outcomes and Healthcare Service Utilization
A study comparing the benefits of pre-habilitation exercise to standard care prior to total knee arthroplasy
Read the detailed description
Recovery post Total Knee Replacement Surgery ((TKA) has been a subject of interest. In a study of 379 patients who had hip or knee replacement surgery, it was reported that at 6 months post-surgery patients with better baseline function had superior functional ability and less pain than patients with lower function at baseline. Another study of 276 patients undergoing TKA reported that pre-operative joint function was a predictor of joint function and overall function at 6 months post-surgery. These findings suggest that prehabilitation to increase functional ability prior to TKA may have a positive effect in recovering post-surgery. In a randomized control trial of patients receiving TKA, the group receiving an Exercise Program (prehabilitation) made significant improvements in performance from baseline to before surgery, and at 1 and 3 months post surgery. For the group that did not receive the Exercise Program pre-surgery, significant improvement did not occur until 3 months post surgery. The overall objective of the proposed single-blinded randomized controlled trial is to demonstrate that a well designed prehabilitation program for patients receiving TKA surgery will significantly improve outcomes related to pain and function and may reduce utilization of health care services post surgery.
In this randomized control trial we hypothesize that the group of participants who receive a prehabilitation Exercise Program will recover quicker than patients who do not receive the Exercise Program based on several measures of performance including pain, quadriceps strength, range of motion and quality of life.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Prehabilitation
- Keywords
- Knee Arthroplasty, Knee Replacement, Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
The three week, 3 days / week prehabilitation exercise program will consist of resistance training, step training and stretching(flexibility) as well as cardiovascular endurance training. Intensity of training will increase over the three weeks. Classes will be delivered over a four week period with a gap during the third week allowing additional time for participants to practice their exercises. The home exercise program will be designed to account for the additional week.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | The no intervention group will receive standard treatment that includes a four hour class pre-surgery consisting of a description of the surgery, what to expect in the hospital and during recovery and some exercises to be done in preparation for surgery. |
| Prehabilitation | Experimental | Prehabilitation:The experimental group will receive a three week prehabilitation program prior to surgery in addition to standard treatment. Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC, a self-assessment tool, is a valid and reliable instrument developed specifically to measure outcomes related to interventions for treatment of the hip and knee. Consisting of three domains: physical, pain and stiffness; a total score is derived by aggregating the domain scores.
Measured: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Secondary outcomes (6)
Six Minute Walk
A valid and reliable measure of total distance walked in six minutes.
Measured: Change from baseline to pre-surgery, 4, 14, 26 weeks post-surgery
Gait Speed
Gait speed will be measured with the 10 meter walk. It will be assessed under two conditions: 1) instructed to walk at normal speed, 2) instructed to walk as fast as possible.
Measured: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Knee Range of Motion (ROM)
Knee ROM (extension and flexion) will be measured with a goniometer at the surgical joint.
Measured: Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgery
Medical Outcomes Study Short Form-36 (SF-36)
The SF-36 measures 8 dimensions of outcome: physical functioning, social functioning, role-physical, bodily pain, mental health, role-emotional, vitality and general health.
Measured: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Sit-to-stand repetitions in 30 seconds
Number of complete stand up to sit down cycles is counted.
Measured: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Pain
Pain will be measured upon completion of each of the functional tasks (gait speed, six-minute walk and sit to stand) using a Visual Analog Scale from 0 to 10 where 0 is no pain and 10 is severe pain.
Measured: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start1 Jan 2014
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- 2 arms, one intervention, one control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Franco, Allina Health System
- Investigators
- Robin Crandall, M.D., Principal investigator, Unity Hospital, Allina HealthLaura Franco, PT, OCS, Principal investigator, Courage Kenny Rehabilitation Institute, Allina Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844934
- Sponsor's protocol ID
- Study 3963-2 IRB
- Status last verified
- Feb 2017
- First submitted
- 30 Apr 2013
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prehabilitation in Total Knee Arthroplasty: Outcomes and Healthcare Service Utilization
- ClinicalTrials.gov ID
- NCT01844934
- Acronym / sponsor ID
- Study 3963-2 IRB
- Conditions
- Total Knee Arthroplasty
- Keywords
- Knee Arthroplasty, Knee Replacement, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 3 May 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.
A study comparing the benefits of pre-habilitation exercise to standard care prior to total knee arthroplasy
Detailed description
Recovery post Total Knee Replacement Surgery ((TKA) has been a subject of interest. In a study of 379 patients who had hip or knee replacement surgery, it was reported that at 6 months post-surgery patients with better baseline function had superior functional ability and less pain than patients with lower function at baseline. Another study of 276 patients undergoing TKA reported that pre-operative joint function was a predictor of joint function and overall function at 6 months post-surgery. These findings suggest that prehabilitation to increase functional ability prior to TKA may have a positive effect in recovering post-surgery. In a randomized control trial of patients receiving TKA, the group receiving an Exercise Program (prehabilitation) made significant improvements in performance from baseline to before surgery, and at 1 and 3 months post surgery. For the group that did not receive the Exercise Program pre-surgery, significant improvement did not occur until 3 months post surgery. The overall objective of the proposed single-blinded randomized controlled trial is to demonstrate that a well designed prehabilitation program for patients receiving TKA surgery will significantly improve outcomes related to pain and function and may reduce utilization of health care services post surgery.
In this randomized control trial we hypothesize that the group of participants who receive a prehabilitation Exercise Program will recover quicker than patients who do not receive the Exercise Program based on several measures of performance including pain, quadriceps strength, range of motion and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arms, one intervention, one control
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –The no intervention group will receive standard treatment that includes a four hour class pre-surgery consisting of a description of the surgery, what to expect in the hospital and during recovery and some exercises to be done in preparation for surgery. |
| Prehabilitation | Experimental | Other: PrehabilitationPrehabilitation:The experimental group will receive a three week prehabilitation program prior to surgery in addition to standard treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled to undergo unilateral TKA surgery
- Ambulatory
- Community dwelling (living at home)
- Able to participate in moderate intensity exercise
- American Society of Anesthesiologists Physical Status Classification(ASA) 1 - 3
Key exclusion criteria (2 listed)
- Patients who are planning a second surgery of the lower limbs during the six months post-surgery
- Have the effect of peripheral vascular disease or stroke on walking
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 |
|---|---|---|
| PrehabilitationThe three week, 3 days / week prehabilitation exercise program will consist of resistance training, step training and stretching(flexibility) as well as cardiovascular endurance training. Intensity of training will increase over the three weeks. Classes will be delivered over a four week period with a gap during the third week allowing additional time for participants to practice their exercises. The home exercise program will be designed to account for the additional week. | Other | Prehabilitation |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
WOMAC, a self-assessment tool, is a valid and reliable instrument developed specifically to measure outcomes related to interventions for treatment of the hip and knee. Consisting of three domains: physical, pain and stiffness; a total score is derived by aggregating the domain scores.
6 secondary outcomes
Six Minute Walk
Time frame: Change from baseline to pre-surgery, 4, 14, 26 weeks post-surgery
Gait Speed
Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Knee Range of Motion (ROM)
Time frame: Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgery
Medical Outcomes Study Short Form-36 (SF-36)
Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Sit-to-stand repetitions in 30 seconds
Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Pain
Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
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 10 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Robin Crandall, M.D. principal investigator
Unity Hospital, Allina Health
Laura Franco, PT, OCS principal investigator
Courage Kenny Rehabilitation Institute, Allina Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Total Knee Arthroplasty, run by Allina Health System 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 6 inclusion and 2 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 10 Feb 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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.