Clinical trial NCT06363643: Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.
Official title: Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation. Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee and Hip
Lower Limb Arthroplasty
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity.

Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations.


Eligibility criteria: Inclusion Criteria:

* Elective Knee or Total Hip arthroplasty

Exclusion Criteria:

* concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroplasty has been indicated) that modify the ability to walk;
* pathologies that modify the balance (neurological and/or vestibular);
* contraindications to the use of medical equipment used in the study;
* inability to understand and sign informed consent.

Primary outcomes:
measure: Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4.
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: "Città di Pavia Healthcare Institute"
Study officials:
affiliation: University of Pavia (Italy)
name: Luca Marin, PhD
role: PRINCIPAL_INVESTIGATOR
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