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Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.

Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation. Randomized Controlled Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06363643
Enrollment
44
Registered
2024-04-12
Start date
2024-04-22
Completion date
2024-07-26
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Arthroplasty, Osteo Arthritis Knee and Hip

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.

Interventions

DEVICEELECTROSTIMULATION (ES)

ES will receive the electrostimulator directly at home and will do three weekly Tele supervised sessions of 30 minutes of indirect electrostimulation. The treatment will last 4 weeks.

OTHEREXERCISE (C)

C will perform three weekly Tele supervised sessions of exercise. The treatment will last 4 weeks.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4Baseline and week 430CST is a validated tool to assess strength and endurance of Lower limbs. The patient is seated in a 17 high chair. Count the number of times the patient comes to a full standing position in 30 seconds.

Secondary

MeasureTime frameDescription
Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4.Baseline and week 4TUG is a validated tool to assess dynamic balance and functional mobility. The patient getting up from a chair from the sitting to the bipedal position, walking three meters, turning, returning, and sitting on the chair again. The variable measured is the total time, in seconds, taken by the test.

Countries

Italy

Contacts

Primary ContactLuca Marin
luca.marin@unipv.it347 2204734

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 27, 2026