OsteoporosisDHEAL-COM-OPNCT06984380
Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Osteoporosis (DHEAL-COM-OP)
A study testing Telerehabilitation in people with Osteoporosis and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoporosis, Older People
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS INRCA Hospital
Ancona, 60127
Elvira Maranesi, PhD, e.maranesi@inrca.it
Giovanni Renato Riccardi, MD
About this study
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.
Read the 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.
- Conditions
- Osteoporosis, Older People
- Being tested
- Telerehabilitation, Usual care
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Older patients with osteoporosis Receives: Other: Telerehabilitation |
| Usual care | Sham comparator | Older patients with osteoporosis Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 12 weeks later
Secondary outcomes (3)
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.
Measured: At baseline and 12 weeks later
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.
Measured: At baseline and 12 weeks later
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
Measured: At baseline and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Giovanni Renato Riccardi, MD, Study director, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984380
- Sponsor's protocol ID
- INRCA_006_2024
- Acronym
- DHEAL-COM-OP
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Osteoporosis (DHEAL-COM-OP)
- ClinicalTrials.gov ID
- NCT06984380
- Acronym / sponsor ID
- DHEAL-COM-OP / INRCA_006_2024
- Conditions
- Osteoporosis, Older People
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: TelerehabilitationOlder patients with osteoporosis |
| Usual care | Sham comparator | Other: Usual careOlder patients with osteoporosis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationPatients 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. | Other | Intervention arm |
| Usual careParticipants 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. | Other | Usual care |
Primary outcome
Improvement in physical performance
Time frame: At baseline and 12 weeks later
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.
3 secondary outcomes
Improvement in physical function
Time frame: At baseline and 12 weeks later
Improvement in quality of life
Time frame: At baseline and 12 weeks later
Improvement in mobility
Time frame: At baseline and 12 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Renato Riccardi, MD study director
IRCCS INRCA, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Osteoporosis and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in physical performance (time frame: At baseline and 12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.