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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Université de Montréal
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Change in Lower Extremity Functional Scale (LEFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)(At Baseline and 12 weeks after baseline)
- Change in Global Rating of Change scale (GRC)(At Baseline and 12 weeks after baseline)
- Change in Self-Paced Walk test(At Baseline and 12 weeks after baseline)
- Change in Short Form (36) Health Survey(At Baseline and 12 weeks after baseline)
- Change in StairTest (ST)(At Baseline and 12 weeks after baseline)
- Satisfaction questionnaire(At 12 weeks after baseline)
- Change in Timed Up and Go (TUG)(At Baseline and 12 weeks after baseline)
Investigators
François Desmeules
Professor, School of Rehabilitation, University of Montreal
Université de Montréal