Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Osteoporosis (DHEAL-COM-OP)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Not yet enrolling

Conditions: Osteoporosis; Older People

Treatments: Other: Telerehabilitation; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06984380

INRCA_006_2024

Details and patient eligibility

About

The DHEAL-COM-OP study is characterized as a feasibility study. The general objective is to evaluate the improvement in the physical performance of patients with osteoporosis detected through the Performance-Oriented Mobility Assessment (POMA) scale, following a rehabilitation intervention integrated with the BTS TELEREHAB technology.

Full description

The DHEAL COM project aims to evaluate the improvement in physical performance of patients with osteoporosis following a rehabilitation intervention integrated with technology in telerehabilitation. Specifically, the project aims to develop a telerehabilitation platform that enables people to perform physical activity at home.

The first objective of the project is to evaluate the improvement of physical performance, in terms of gait and balance capability, of patients with osteoporosis detected through the Tinetti Performance Oriented Mobility Assessment (POMA) scale following an integrated rehabilitation intervention with BTS TELEREHAB technology.

Forty elderly people with osteoporosis aged at least 65 years who wish to participate in the study and who meet the inclusion and exclusion criteria. Participants will be randomized into experimental group (GS) and control group (GC). Patients in the experimental group will receive a personalized program of home tele-rehabilitation exercises divided into 3 workouts per week, for a duration of 12 weeks. The training sessions will be organized as follows: one session will be carried out in telerehabilitation with the support of the physiotherapist in small groups of maximum 5 patients; in the remaining two the patient will perform the exercises independently at home. Before starting the rehabilitation program, the patient will receive training with the technology in the hospital, in the presence of the physiotherapist.

Patients in the control group will be offered activities to perform at home, with the same frequency, in line with the usual care activities already proposed by the Rehabilitation Unit.

Patients will be contacted periodically by the physiotherapist to evaluate the improvement of the main and secondary outcomes detailed in the following protocol.

Enrollment: 40 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a positive MOC for osteoporosis without a history of major fractures (femur and vertebrae);
• Functional Ambulation Category (FAC) score ≥ 3;
• Stability of drug treatment for at least 1 month;
• Maintaining an upright position independently > 30";
• Mini-Mental State Examination (MMSE) ≥ 24;
• Geriatric depression scale (GDS) < 2;

Exclusion criteria

• Myocardial infarction or stroke within 6 months;
• Painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility;
• Uncontrolled hypertension
• Metastatic cancer or immunosuppressive therapy;
• Significant visual or hearing impairment

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Older patients with osteoporosis

Treatment:

Other: Telerehabilitation

Usual care

Sham Comparator group

Description:

Older patients with osteoporosis

Treatment:

Other: Usual care