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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorIstituto Nazionale di Ricovero e Cura per Anziani

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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";

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telerehabilitation

    Other intervention

    Patients will receive a personalised home tele-rehabilitation exercise program consisting of 3 sessions per week for a duration of 12 weeks. BTS TELEREHAB is a platform that allows the delivery of remote rehabilitation services. The patient is given the system to take home, where they will connect the small Brain PC, that is the computer unit of the BTS TELEREHAB solution, to their television. During motor rehabilitation sessions, the patient wears a special inertial sensor, the G-Sensor device, that measures movements in real-time, allowing the clinician to remotely monitor the correct execution of the exercises. In addition to the proposed therapeutic exercises, functional assessment tests are also included for patient follow-up. The presence of the inertial sensor supports the clinician in verifying the correct execution of the motor task and in the precise quantification of joint mobility.

  • Usual care

    Other intervention

    Participants will receive a booklet containing information and activities on well- being. They will be invited to do whatever they wish with the information booklet and the proposed exercises.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Usual careSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in physical performance

The physical performance, in terms of balance and gait ability, will be detected through the Tinetti Performance Oriented Mobility Assessment (POMA) scale. The maximum possible score is 28 points. The total POMA score provides an indication of an individual's fall risk: * 25-28 points: Indicates a low risk of falls * 19-24 points: Indicates a medium or moderate risk of falls * Less than 19 points (\< 19): Indicates a high risk of falls The improvement is assessed in an increase in the POMA score of at least 3 points.

Time frame
At baseline and 12 weeks later

Secondary outcomes

1

Improvement in physical function

Physical performance will be assessed using the Short Physical Performance Battery (SPPB). The total SPPB score ranges from 0 to 12, with 12 indicating the best performance.

Time frame
At baseline and 12 weeks later
2

Improvement in quality of life

The quality of life will be evaluated by the SF-12 Health Survey (SF-12). It consists of 12 items that produce two measures related to two different aspects of health: physical health (PCS) and mental health (MCS). Both typically ranging from 0 to 100, where 0 represents the worst health status and 100 represents the best health status.

Time frame
At baseline and 12 weeks later
3

Improvement in mobility

The mobility will be measured by the Time Up and Go (TUG) test. It measures the time it takes a person to get up from a chair, walk three meters, turn around, return to the chair, and sit down again. During the test, the person should wear regularly used shoes and use any normally used Mobility Aids. A score of ten seconds or less indicates normal mobility; times between 11 and 20 seconds are within normal limits for frail elderly and disabled patients; times greater than 20 seconds indicate that the person needs outside assistance and the need for further examination and intervention. A score above 30 seconds suggests that the person may be prone to falls

Time frame
At baseline and 12 weeks later

Other outcomes

Sponsors and contacts

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