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

NCT06984380 | Not Yet Recruiting

• 1 other identifier: INRCA_006_2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Older People

Outcome Measures

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.

  At baseline and 12 weeks later

Secondary Outcomes (3)

• Improvement in physical function

  At baseline and 12 weeks later

• Improvement in quality of life

  At baseline and 12 weeks later

• Improvement in mobility

  At baseline and 12 weeks later

Study Arms (2)

Intervention arm

EXPERIMENTAL

Older patients with osteoporosis

Other: Telerehabilitation

Usual care

SHAM COMPARATOR

Older patients with osteoporosis

Other: Usual care

Interventions

Telerehabilitation OTHER

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.

Intervention arm

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS INRCA Hospital

Ancona, 60127, Italy

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Giovanni Renato Riccardi, MD

  IRCCS INRCA, Ancona, Italy

  STUDY DIRECTOR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

0718003719; a.bonfigli@inrca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)