Clinical trial NCT06984380: Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Osteoporosis (DHEAL-COM-OP)
Official title: Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Osteoporosis (DHEAL-COM-OP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoporosis
Older People
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2025-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in physical performance
timeFrame: At baseline and 12 weeks later
Secondary outcomes:
measure: Improvement in physical function
timeFrame: At baseline and 12 weeks later
measure: Improvement in quality of life
timeFrame: At baseline and 12 weeks later
measure: Improvement in mobility
timeFrame: At baseline and 12 weeks later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Giovanni Renato Riccardi, MD
role: STUDY_DIRECTOR
References: