OsteoarthritisNCT02636751
Effects of Tele- or In-person Prehabilitation in Candidates Awaiting Total Hip or Knee Arthroplasty
A study testing 12-week prehabilitation program and Walking aid adjustment in people with Osteoarthritis, run by Université de Montréal at 1 site in Canada.
Trial summary
This pilot single blind randomized controlled trial aims therefore to evaluate the feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person prehabilitation or to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- 12-week prehabilitation program and Walking aid adjustment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years;
- Waiting for a TKA or a THA
- Suffering from severe OA of hip or knee
- Quebec resident covered by the Régie de l'assurance maladie du Québec (Quebec public healthcare insurance)
- Speaks French
- Has a high-speed internet connection.
Who cannot join
- Suffering from inflammatory arthritis
- Scheduled for a bilateral surgery
- Has had a lower limb surgery in the past 6 months
- Scheduled for a revision of a previous TKA or THA
- Planned for a wide acetabular head hip prosthesis or a hip articular resurfacing
- Receiving a compensation from Quebec Commission de la santé et de la sécurité du travail (government insurer for workers and employers)
- Suffering from a severe psychiatric neurologic or cardiac disorder, or other types of disorders that could interfere with the rehabilitation program.
Trial locations and contacts
1 site in 1 country.
Patrick Doiron-Cadrin, B.Sc. contact
Véronique Lowry, M.Sc. contact
Canada1 site, 1 recruiting
- Recruiting
CIUSSS Centre-est-de-l'île-de-Montréal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
About this study
Official title: Effects of a Tele-prehabilitation Program or an In-person Prehabilitation Program Compared to a Usual Care Control Group in Participants Awaiting Total Hip or Knee Arthroplasty: A Pilot Single Blind Randomized Controlled Trial
This pilot single blind randomized controlled trial aims therefore to evaluate the feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person prehabilitation or to usual care.
Read the detailed description
BACKGROUND
Osteoarthritis (OA) is a very common disorder that affects almost every Canadian over 65 years of age. Future estimations indicate the incidence of OA will increase by at least 26% over the next 30 years in Canada. Hip and knee are the most affected joints by OA and these conditions incur important disability. Lower limb OA is initially treated conservatively with therapeutic interventions such as physical activity modification, exercise, weight control, and medication. Surgical interventions such as total joint arthroplasty (TJA) have been proven a treatment of choice for the most severe cases. However, the accessibility to such surgery often comes up against long wait lists, and prolonged wait time may lead to deleterious effects on the health status and quality of life of the awaiting patients.
Prehabilitation refers to education and exercising before a surgery. Attention to prehabilitation has increased in the last decade and a growing body of evidence suggests that it could have a positive effect on postoperative outcomes and may reduce disabilities before and after surgery for a number of conditions. In the context of prehabilitation for TJA, trials have already shown that a rehabilitation exercise program before a TJA could lead to a shorter hospitalisation length of stay, in addition to increased muscle strength and range of motion following a total hip or knee arthroplasty. However, results concerning the longer-term effects of prehabilitation after a TJA tend to be inconsistent and further research is actually needed to better understand the effects of prehabilitation over the post-surgical course.
As the aging population and the constant increase in chronic diseases keep pressuring the healthcare systems worldwide, lack of resources tends to lengthen wait time for surgery like TJA. Long wait times for such medical interventions have a negative impact on pain, function and quality of life. Policymakers have therefore been searching for a care optimisation strategy to improve healthcare accessibility to prehabilitation.
Among the solutions stands the use of technology to help deliver more efficiently rehabilitation services or to improve access to these types of care. Telerehabilitation has gained increased recognition and it is defined as the provision of rehabilitation services at a distance, using information and communication technologies. Previous studies have already shown that telerehabilitation programs are feasible in a home-care setting.
Tousignant et al. demonstrated that a telerehabilitation program was as efficient and less expensive than conventional physiotherapy after a total knee arthroplasty (TKA). Bedra et al. qualified as viable a home-based telerehabilitation program after a hip fracture, while Anton et al. demonstrated that a Kinect™-based system can be an adjuvant to physiotherapy after a total hip replacement.
Those programs present good opportunities for optimising the delivery of care in community rehabilitation, especially by increasing the number of patients seen in a single day, by reducing medical costs and travel time, and by providing access to medical care otherwise unavailable in rural areas. However, no study, to our knowledge, analysed the outcome of telerehabilitation before proceeding to a total joint replacement.
This pilot single blind randomized controlled trial aims therefore to evaluate the feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person prehabilitation or to usual care. Our hypothesis is that a 12-week prehabilitation program will significantly increase functional mobility and quality of life for the subjects in the experimental groups, but not in the control group.
EXAMINATION PROCEDURE AND RANDOMIZATION
During the baseline evaluation at the Maisonneuve-Rosemont Research Center, eligible participants will complete a questionnaire covering sociodemographic status, comorbidities, and medication usage. Patients will be asked to fill in four French validated self-reported questionnaires: the Lower Extremity Functional Scale (LEFS-CF), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-CF), the Short Form Health Survey (SF-36-CF) and a Global Rating of Change Scale (GRC-CF). Three physical functional performance measures will also be collected: the self-paced walk (SPW), the timed up-and-go (TUG) and timed stair tests (ST). These tests are oriented toward activities of daily living and have been validated with a geriatric population. They are reliable, reproducible, and responsive to change. They also have widely been used for measuring the outcomes of patients undergoing a TJA. An online version of the questionnaires using the Survey Monkey® platform or a paper version will be provided to the participants. Finally, a logbook will be given to the participants. They will be asked to record the exercises executed at home, including the number of series and repetitions, in addition to the medication intake. This logbook will allow a monitoring of the compliance rate to the programs and also the advent of any adverse effects.
Patients will then be randomly assigned to the control group or to one of the two experimental groups. An independent research assistant, blind to the baseline evaluation results, will open the randomization envelope indicating the participant's assignment to a group. A random number generator will be used to establish randomization lists prior to the initiation of the study. A member of the research team, not involved with data collection, will generate the randomization list. Blocked randomization of 6 will be used to make sure that three equal groups of 12 subjects participants are obtained.
Participants will be reassessed at 12 weeks by a blind research assistant, after the completion of the interventions. The same evaluation tools as at baseline will be used, according to a standardized procedure. A satisfaction questionnaire about the telecommunication software experience will be filled by participants and therapists who used a telecommunication software.
- Conditions
- Osteoarthritis
- Being tested
- 12-week prehabilitation program, Walking aid adjustment, Information about pain control
- Keywords
- Prehabilitation, Telemedicine, Osteoarthritis, Arthroplasty, Hip, Knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week prehabilitation programBehavioural
stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities
Walking aid adjustmentDevice
Walking aid adjustment
Information about pain controlBehavioural
General information about pain control, such as ice application and medication usage
| Study group | Role | What they receive |
|---|---|---|
| In-person prehabilitation group | Experimental | The participants in this group will receive a 12-week rehabilitation program (2x/week) including, education, stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities, in addition to walking aid adjustment. General information about pain control, such as ice application and medication usage will also be provided Receives: Behavioral: 12-week prehabilitation program; Device: Walking aid adjustment; Behavioral: Information about pain control |
| Tele-prehabilitation group | Experimental | The participants in this group will receive a 12-week rehabilitation program (2x/week) including, education, stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities, in addition to walking aid adjustment using a telecommunication software (Reacts®, Facetime® or Skype®). General information about pain control, such as ice application and medication usage will also be provided. Receives: Behavioral: 12-week prehabilitation program; Device: Walking aid adjustment; Behavioral: Information about pain control |
| Usual care group | Active comparator | The participants in this group will be provided with the hospital's usual documentation before total joint arthroplasties, consisting of information regarding the pre- and post-surgery course and medication. Receives: Device: Walking aid adjustment; Behavioral: Information about pain control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Functional Scale (LEFS)
20-item questionnaire. Each item is rated on a five-point scale (0= extreme difficulty or unable to perform activity, 4= no difficulty); total scores range from 0 to 80, and lower scores represent greater difficulty.
Measured: At Baseline and 12 weeks after baseline
Secondary outcomes (7)
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Self-administered questionnaire. 24 items divided into 3 subscales: pain (5 items), stiffness (2 items) and physical function (17 items). Each item is scored on a five-point scale according to difficulty experienced (0 = none and 4 = extremely difficult(40).
Measured: At Baseline and 12 weeks after baseline
Change in Short Form (36) Health Survey
self-administered generic health status measure questionnaire. It calculates 8 multi-item scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 summary scales, the physical component summary (PCS) and the mental component summary (MCS).
Measured: At Baseline and 12 weeks after baseline
Change in Global Rating of Change scale (GRC)
designed to quantify a patient's perceived improvement or deterioration over time. Using an 11-point GRC scale, ranging from -5 (a great deal worse) to 0 (about the same) to +5 (a great deal better), participants will be asked to answer the following question: "Overall, has there been any change in your condition since the initial evaluation done at the beginning of your rehabilitation program? Please indicate if there has been any change in your condition by choosing one of the following options".
Measured: At Baseline and 12 weeks after baseline
Change in Timed Up and Go (TUG)
test that assesses mobility, balance, walking ability, and fall risk in older adults. The patient sits in a chair with his/her back against the chair back. On the command "go", the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated. Time in seconds is the outcome of the test.
Measured: At Baseline and 12 weeks after baseline
Change in StairTest (ST)
Patients are asked to ascend and descend 8 stairs (step height 18.5 cm) in their usual manner, at a safe and comfortable pace. Use of a gait aide and/or of the handrail is allowed as needed(30). Time in seconds is the outcome of the test.
Measured: At Baseline and 12 weeks after baseline
Change in Self-Paced Walk test
Patients are required to walk two lengths of a 20 m indoor course in response to the instructions ''walk as quickly as you can without overexerting yourself.'' Usual gait aides are allowed as needed.
Measured: At Baseline and 12 weeks after baseline
Satisfaction questionnaire
Satisfaction questionnaire about the use of a telemedicine software
Measured: At 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Maisonneuve-Rosemont Hospital
- Responsible party
- Principal investigator, François Desmeules, Université de Montréal
- Investigators
- François Desmeules, Ph.D., Principal investigator, CIUSSS Centre-Est-de-l"île-de-Montréal, Installation Maisonneuve-Rosemont Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636751
- Sponsor's protocol ID
- DOIP2015
- Status last verified
- Jun 2016
- First submitted
- 14 Dec 2015
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Feasibility and preliminary effects of a tele-prehabilitation program and an in-person prehablitation program compared to usual care for total hip or knee arthroplasty candidates: a pilot randomized controlled trial. Disabil Rehabil. 2020 Apr;42(7):989-998. doi: 10.1080/09638288.2018.1515992. Epub 2019 Jan 13.
PubMed 30638076Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial. Contemp Clin Trials Commun. 2016 Oct 5;4:192-198. doi: 10.1016/j.conctc.2016.10.001. eCollection 2016 Dec 15.
PubMed 29736482
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Tele-prehabilitation Program or an In-person Prehabilitation Program Compared to a Usual Care Control Group in Participants Awaiting Total Hip or Knee Arthroplasty: A Pilot Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02636751
- Acronym / sponsor ID
- DOIP2015
- Conditions
- Osteoarthritis
- Keywords
- Prehabilitation, Telemedicine, Osteoarthritis, Arthroplasty, Hip, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Maisonneuve-Rosemont Hospital
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Dec 2015 (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.
This pilot single blind randomized controlled trial aims therefore to evaluate the feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person prehabilitation or to usual care.
Detailed description
BACKGROUND
Osteoarthritis (OA) is a very common disorder that affects almost every Canadian over 65 years of age. Future estimations indicate the incidence of OA will increase by at least 26% over the next 30 years in Canada. Hip and knee are the most affected joints by OA and these conditions incur important disability. Lower limb OA is initially treated conservatively with therapeutic interventions such as physical activity modification, exercise, weight control, and medication. Surgical interventions such as total joint arthroplasty (TJA) have been proven a treatment of choice for the most severe cases. However, the accessibility to such surgery often comes up against long wait lists, and prolonged wait time may lead to deleterious effects on the health status and quality of life of the awaiting patients.
Prehabilitation refers to education and exercising before a surgery. Attention to prehabilitation has increased in the last decade and a growing body of evidence suggests that it could have a positive effect on postoperative outcomes and may reduce disabilities before and after surgery for a number of conditions. In the context of prehabilitation for TJA, trials have already shown that a rehabilitation exercise program before a TJA could lead to a shorter hospitalisation length of stay, in addition to increased muscle strength and range of motion following a total hip or knee arthroplasty. However, results concerning the longer-term effects of prehabilitation after a TJA tend to be inconsistent and further research is actually needed to better understand the effects of prehabilitation over the post-surgical course.
As the aging population and the constant increase in chronic diseases keep pressuring the healthcare systems worldwide, lack of resources tends to lengthen wait time for surgery like TJA. Long wait times for such medical interventions have a negative impact on pain, function and quality of life. Policymakers have therefore been searching for a care optimisation strategy to improve healthcare accessibility to prehabilitation.
Among the solutions stands the use of technology to help deliver more efficiently rehabilitation services or to improve access to these types of care. Telerehabilitation has gained increased recognition and it is defined as the provision of rehabilitation services at a distance, using information and communication technologies. Previous studies have already shown that telerehabilitation programs are feasible in a home-care setting.
Tousignant et al. demonstrated that a telerehabilitation program was as efficient and less expensive than conventional physiotherapy after a total knee arthroplasty (TKA). Bedra et al. qualified as viable a home-based telerehabilitation program after a hip fracture, while Anton et al. demonstrated that a Kinect™-based system can be an adjuvant to physiotherapy after a total hip replacement.
Those programs present good opportunities for optimising the delivery of care in community rehabilitation, especially by increasing the number of patients seen in a single day, by reducing medical costs and travel time, and by providing access to medical care otherwise unavailable in rural areas. However, no study, to our knowledge, analysed the outcome of telerehabilitation before proceeding to a total joint replacement.
This pilot single blind randomized controlled trial aims therefore to evaluate the feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person prehabilitation or to usual care. Our hypothesis is that a 12-week prehabilitation program will significantly increase functional mobility and quality of life for the subjects in the experimental groups, but not in the control group.
EXAMINATION PROCEDURE AND RANDOMIZATION
During the baseline evaluation at the Maisonneuve-Rosemont Research Center, eligible participants will complete a questionnaire covering sociodemographic status, comorbidities, and medication usage. Patients will be asked to fill in four French validated self-reported questionnaires: the Lower Extremity Functional Scale (LEFS-CF), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-CF), the Short Form Health Survey (SF-36-CF) and a Global Rating of Change Scale (GRC-CF). Three physical functional performance measures will also be collected: the self-paced walk (SPW), the timed up-and-go (TUG) and timed stair tests (ST). These tests are oriented toward activities of daily living and have been validated with a geriatric population. They are reliable, reproducible, and responsive to change. They also have widely been used for measuring the outcomes of patients undergoing a TJA. An online version of the questionnaires using the Survey Monkey® platform or a paper version will be provided to the participants. Finally, a logbook will be given to the participants. They will be asked to record the exercises executed at home, including the number of series and repetitions, in addition to the medication intake. This logbook will allow a monitoring of the compliance rate to the programs and also the advent of any adverse effects.
Patients will then be randomly assigned to the control group or to one of the two experimental groups. An independent research assistant, blind to the baseline evaluation results, will open the randomization envelope indicating the participant's assignment to a group. A random number generator will be used to establish randomization lists prior to the initiation of the study. A member of the research team, not involved with data collection, will generate the randomization list. Blocked randomization of 6 will be used to make sure that three equal groups of 12 subjects participants are obtained.
Participants will be reassessed at 12 weeks by a blind research assistant, after the completion of the interventions. The same evaluation tools as at baseline will be used, according to a standardized procedure. A satisfaction questionnaire about the telecommunication software experience will be filled by participants and therapists who used a telecommunication software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person prehabilitation group | Experimental | Behavioral: 12-week prehabilitation program, Device: Walking aid adjustment, Behavioral: Information about pain controlThe participants in this group will receive a 12-week rehabilitation program (2x/week) including, education, stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities, in addition to walking aid adjustment. General information about pain control, such as ice application and medication usage will also be provided |
| Tele-prehabilitation group | Experimental | Behavioral: 12-week prehabilitation program, Device: Walking aid adjustment, Behavioral: Information about pain controlThe participants in this group will receive a 12-week rehabilitation program (2x/week) including, education, stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities, in addition to walking aid adjustment using a telecommunication software (Reacts®, Facetime® or Skype®). General information about pain control, such as ice application and medication usage will also be provided. |
| Usual care group | Active comparator | Device: Walking aid adjustment, Behavioral: Information about pain controlThe participants in this group will be provided with the hospital's usual documentation before total joint arthroplasties, consisting of information regarding the pre- and post-surgery course and medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18 years;
- Waiting for a TKA or a THA
- Suffering from severe OA of hip or knee
- Quebec resident covered by the Régie de l'assurance maladie du Québec (Quebec public healthcare insurance)
- Speaks French
Key exclusion criteria (7 listed)
- Suffering from inflammatory arthritis
- Scheduled for a bilateral surgery
- Has had a lower limb surgery in the past 6 months
- Scheduled for a revision of a previous TKA or THA
- Planned for a wide acetabular head hip prosthesis or a hip articular resurfacing
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 |
|---|---|---|
| 12-week prehabilitation programstretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities | Behavioural | In-person prehabilitation group, Tele-prehabilitation group |
| Walking aid adjustmentWalking aid adjustment | Device | In-person prehabilitation group, Tele-prehabilitation group, Usual care group |
| Information about pain controlGeneral information about pain control, such as ice application and medication usage | Behavioural | In-person prehabilitation group, Tele-prehabilitation group, Usual care group |
Primary outcome
Change in Lower Extremity Functional Scale (LEFS)
Time frame: At Baseline and 12 weeks after baseline
20-item questionnaire. Each item is rated on a five-point scale (0= extreme difficulty or unable to perform activity, 4= no difficulty); total scores range from 0 to 80, and lower scores represent greater difficulty.
7 secondary outcomes
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: At Baseline and 12 weeks after baseline
Change in Short Form (36) Health Survey
Time frame: At Baseline and 12 weeks after baseline
Change in Global Rating of Change scale (GRC)
Time frame: At Baseline and 12 weeks after baseline
Change in Timed Up and Go (TUG)
Time frame: At Baseline and 12 weeks after baseline
Change in StairTest (ST)
Time frame: At Baseline and 12 weeks after baseline
Change in Self-Paced Walk test
Time frame: At Baseline and 12 weeks after baseline
Satisfaction questionnaire
Time frame: At 12 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
- Derived from this study: PubMed 30638076Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Feasibility and preliminary effects of a tele-prehabilitation program and an in-person prehablitation program compared to usual care for total hip or knee arthroplasty candidates: a pilot randomized controlled trial. Disabil Rehabil. 2020 Apr;42(7):989-998. doi: 10.1080/09638288.2018.1515992. Epub 2019 Jan 13.
- Derived from this study: PubMed 29736482Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial. Contemp Clin Trials Commun. 2016 Oct 5;4:192-198. doi: 10.1016/j.conctc.2016.10.001. eCollection 2016 Dec 15.
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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.
Patrick Doiron-Cadrin, B.Sc. contact
Véronique Lowry, M.Sc. contact
François Desmeules, Ph.D. principal investigator
CIUSSS Centre-Est-de-l"île-de-Montréal, Installation Maisonneuve-Rosemont Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week prehabilitation program and Walking aid adjustment in people with Osteoarthritis, run by Université de Montréal at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 4 Jul 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Doiron-Cadrin, B.Sc. (514-252-3400 ext. 6249), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Extremity Functional Scale (LEFS) (time frame: At Baseline and 12 weeks after baseline). 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 NCT02636751, which also lists 2 linked publications.
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 4 Jul 2016.