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Effects of Tele- or In-person Prehabilitation in Candidates Awaiting Total Hip or Knee Arthroplasty

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
12-week prehabilitation program
Walking aid adjustment
Information about pain control
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Prehabilitation, Telemedicine, Osteoarthritis, Arthroplasty, Hip, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age greater than 18 years;
  2. Waiting for a TKA or a THA
  3. Suffering from severe OA of hip or knee
  4. Quebec resident covered by the Régie de l'assurance maladie du Québec (Quebec public healthcare insurance)
  5. Speaks French
  6. Has a high-speed internet connection.

Exclusion Criteria:

  1. Suffering from inflammatory arthritis
  2. Scheduled for a bilateral surgery
  3. Has had a lower limb surgery in the past 6 months
  4. Scheduled for a revision of a previous TKA or THA
  5. Planned for a wide acetabular head hip prosthesis or a hip articular resurfacing
  6. Receiving a compensation from Quebec Commission de la santé et de la sécurité du travail (government insurer for workers and employers)
  7. Suffering from a severe psychiatric neurologic or cardiac disorder, or other types of disorders that could interfere with the rehabilitation program.

Sites / Locations

  • CIUSSS Centre-est-de-l'île-de-Montréal - Hopital Maisonneuve-RosemontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

In-person prehabilitation group

Tele-prehabilitation group

Usual care group

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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".
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.
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.
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.
Satisfaction questionnaire
Satisfaction questionnaire about the use of a telemedicine software

Full Information

First Posted
December 14, 2015
Last Updated
July 1, 2016
Sponsor
Université de Montréal
Collaborators
Maisonneuve-Rosemont Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02636751
Brief Title
Effects of Tele- or In-person Prehabilitation in Candidates Awaiting Total Hip or Knee Arthroplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Prehabilitation, Telemedicine, Osteoarthritis, Arthroplasty, Hip, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-person prehabilitation group
Arm Type
Experimental
Arm Description
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
Arm Title
Tele-prehabilitation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
12-week prehabilitation program
Intervention Description
stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities
Intervention Type
Device
Intervention Name(s)
Walking aid adjustment
Intervention Description
Walking aid adjustment
Intervention Type
Behavioral
Intervention Name(s)
Information about pain control
Intervention Description
General information about pain control, such as ice application and medication usage
Primary Outcome Measure Information:
Title
Change in Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
At Baseline and 12 weeks after baseline
Secondary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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).
Time Frame
At Baseline and 12 weeks after baseline
Title
Change in Short Form (36) Health Survey
Description
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).
Time Frame
At Baseline and 12 weeks after baseline
Title
Change in Global Rating of Change scale (GRC)
Description
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".
Time Frame
At Baseline and 12 weeks after baseline
Title
Change in Timed Up and Go (TUG)
Description
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.
Time Frame
At Baseline and 12 weeks after baseline
Title
Change in StairTest (ST)
Description
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.
Time Frame
At Baseline and 12 weeks after baseline
Title
Change in Self-Paced Walk test
Description
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.
Time Frame
At Baseline and 12 weeks after baseline
Title
Satisfaction questionnaire
Description
Satisfaction questionnaire about the use of a telemedicine software
Time Frame
At 12 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Doiron-Cadrin, B.Sc.
Phone
514-252-3400
Ext
6249
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique Lowry, M.Sc.
Phone
514-252-3400
Ext
6249
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Desmeules, Ph.D.
Organizational Affiliation
CIUSSS Centre-Est-de-l"île-de-Montréal, Installation Maisonneuve-Rosemont Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIUSSS Centre-est-de-l'île-de-Montréal - Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
30638076
Citation
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.
Results Reference
derived
PubMed Identifier
29736482
Citation
Doiron-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.
Results Reference
derived

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Effects of Tele- or In-person Prehabilitation in Candidates Awaiting Total Hip or Knee Arthroplasty

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