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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02636751
• Other study ID #: DOIP2015
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2015
• Last updated: July 1, 2016
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Université de Montréal
• Contact: Patrick Doiron-Cadrin, B.Sc.
• Phone: 514-252-3400
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• 12-week prehabilitation program
stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities

Device:
• Walking aid adjustment
Walking aid adjustment

Behavioral:
• Information about pain control
General information about pain control, such as ice application and medication usage

Locations

Country	Name	City	State
Canada	CIUSSS Centre-est-de-l'île-de-Montréal - Hopital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Baseline and 12 weeks after baseline	No
Secondary	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).	At Baseline and 12 weeks after baseline	No
Secondary	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).	At Baseline and 12 weeks after baseline	No
Secondary	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".	At Baseline and 12 weeks after baseline	No
Secondary	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.	At Baseline and 12 weeks after baseline	No
Secondary	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.	At Baseline and 12 weeks after baseline	No
Secondary	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.	At Baseline and 12 weeks after baseline	No
Secondary	Satisfaction questionnaire	Satisfaction questionnaire about the use of a telemedicine software	At 12 weeks after baseline	No