Heart FailureHereRehab-HFNCT07539493
Tele-rehabilitation Versus Center-based Rehabilitation in Heart Failure Patients
A study testing Home-Based Cardiac Rehabilitation and Hospital-Based Cardiac Rehabilitation in people with Heart Failure and Cardiac Rehabilitation, run by Azienda Ospedaliero Universitaria di Sassari at 1 site in Italy.
Trial summary
This study is a single-center pilot randomized controlled trial designed to compare home-based cardiac rehabilitation delivered through the HERE solution with standard hospital-based cardiac rehabilitation in patients with clinically stable heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Rehabilitation
- What is being tested?
- Home-Based Cardiac Rehabilitation and Hospital-Based Cardiac Rehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2025to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years Diagnosis of clinically stable heart failure New York Heart Association (NYHA) class I-II Enrollment in a cardiac rehabilitation program Availability of a stable Wi-Fi connection and a smartphone at home Presence of a caregiver trained in the use of the study technology Ability and willingness to provide written informed consent
Who cannot join
- Conditions precluding physical exercise (e.g., bone fractures) Conditions preventing the use of the study technology (e.g., blindness or deafness) Severe cognitive impairment (Six-Item Screener score 0-4) End-stage renal disease requiring dialysis Advanced pulmonary disease Active malignancy Rheumatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-rehabilitation Versus Center-based Rehabilitation in Patients With Heart Failure: a Pilot RCT
This study is a single-center pilot randomized controlled trial designed to compare home-based cardiac rehabilitation delivered through the HERE solution with standard hospital-based cardiac rehabilitation in patients with clinically stable heart failure. Cardiac rehabilitation is recommended to improve functional capacity and clinical outcomes in this population; however, adherence to conventional center-based programs remains suboptimal.
The intervention consists of a structured rehabilitation program delivered over eight sessions, including aerobic and calisthenic exercises, supported by a tablet-based application with real-time monitoring and feedback. Participants in the control group receive the same rehabilitation program in a hospital setting under direct supervision.
Read more
The primary objective of the study is to evaluate the effectiveness of the intervention on functional capacity, measured using the 6-minute walk test. Secondary outcomes include adherence to the rehabilitation program, quality of life, exercise capacity parameters, vital signs, perceived exertion, and patient satisfaction.
This pilot study aims to assess the feasibility and preliminary effectiveness of a technology-supported home-based rehabilitation model to inform the design of future larger trials.
- Conditions
- Heart Failure, Cardiac Rehabilitation
- Being tested
- Home-Based Cardiac Rehabilitation, Hospital-Based Cardiac Rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Cardiac RehabilitationOther
A home-based cardiac rehabilitation program delivered through the HERE solution, consisting of eight sessions performed twice weekly. The intervention includes aerobic exercise using a chair cycle ergometer and anaerobic/calisthenic exercises. The program is supported by a tablet-based application providing guided exercises, real-time monitoring of physiological parameters (heart rate, oxygen saturation, and blood pressure), and feedback. Participants receive prior training on the use of the technology and exercise execution.
Hospital-Based Cardiac RehabilitationOther
A standard hospital-based cardiac rehabilitation program consisting of eight sessions performed twice weekly. The program includes aerobic exercise and anaerobic/calisthenic exercises delivered in the hospital setting under direct supervision by healthcare professionals.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-Based Cardiac Rehabilitation | Active comparator | Participants receive standard hospital-based cardiac rehabilitation. The program consists of eight sessions performed twice weekly and includes the same aerobic and anaerobic/calisthenic exercises as the intervention group. All sessions are delivered in the hospital setting under direct supervision by healthcare professionals. The assessment schedule and outcome measurements are identical to those of the intervention group. Receives: Other: Home-Based Cardiac Rehabilitation; Other: Hospital-Based Cardiac Rehabilitation |
| Home-Based Cardiac Rehabilitation (HERE) | Experimental | A home-based cardiac rehabilitation program delivered through the HERE solution, consisting of eight sessions performed twice weekly. The intervention includes aerobic exercise using a chair cycle ergometer and anaerobic/calisthenic exercises. The program is supported by a tablet-based application providing guided exercises, real-time monitoring of physiological parameters (heart rate, oxygen saturation, and blood pressure), and feedback. Participants receive prior training on the use of the technology and exercise execution. Receives: Other: Home-Based Cardiac Rehabilitation; Other: Hospital-Based Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity (6-Minute Walk Test)
Functional capacity assessed using the 6-minute walk test (6MWT), defined as the distance walked in meters on a flat surface in 6 minutes. Higher values indicate better functional capacity.
Measured: Baseline and Week 4 (within 7 days after the last session)
Secondary outcomes (2)
Adherence to Cardiac Rehabilitation
Adherence defined as the proportion of completed rehabilitation sessions relative to those scheduled, expressed as a percentage.
Measured: At the end of the rehabilitation program
Quality of Life (KCCQ)
Quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item validated instrument with scores ranging from 0 to 100, with higher scores indicating better health status.
Measured: Baseline and Week 4 (within 7 days after the last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start31 Jul 2025
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Micheluzzi, Azienda Ospedaliero Universitaria di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539493
- Sponsor's protocol ID
- AOSassari_HF_2026
- Acronym
- HereRehab-HF
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-rehabilitation Versus Center-based Rehabilitation in Patients With Heart Failure: a Pilot RCT
- ClinicalTrials.gov ID
- NCT07539493
- Acronym / sponsor ID
- HereRehab-HF / AOSassari_HF_2026
- Conditions
- Heart Failure, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria di SassariUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 20 Apr 2026 (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.
This study is a single-center pilot randomized controlled trial designed to compare home-based cardiac rehabilitation delivered through the HERE solution with standard hospital-based cardiac rehabilitation in patients with clinically stable heart failure. Cardiac rehabilitation is recommended to improve functional capacity and clinical outcomes in this population; however, adherence to conventional center-based programs remains suboptimal.
The intervention consists of a structured rehabilitation program delivered over eight sessions, including aerobic and calisthenic exercises, supported by a tablet-based application with real-time monitoring and feedback. Participants in the control group receive the same rehabilitation program in a hospital setting under direct supervision.
The primary objective of the study is to evaluate the effectiveness of the intervention on functional capacity, measured using the 6-minute walk test. Secondary outcomes include adherence to the rehabilitation program, quality of life, exercise capacity parameters, vital signs, perceived exertion, and patient satisfaction.
This pilot study aims to assess the feasibility and preliminary effectiveness of a technology-supported home-based rehabilitation model to inform the design of future larger trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-Based Cardiac Rehabilitation | Active comparator | Other: Home-Based Cardiac Rehabilitation, Other: Hospital-Based Cardiac RehabilitationParticipants receive standard hospital-based cardiac rehabilitation. The program consists of eight sessions performed twice weekly and includes the same aerobic and anaerobic/calisthenic exercises as the intervention group. All sessions are delivered in the hospital setting under direct supervision by healthcare professionals. The assessment schedule and outcome measurements are identical to those of the intervention group. |
| Home-Based Cardiac Rehabilitation (HERE) | Experimental | Other: Home-Based Cardiac Rehabilitation, Other: Hospital-Based Cardiac RehabilitationA home-based cardiac rehabilitation program delivered through the HERE solution, consisting of eight sessions performed twice weekly. The intervention includes aerobic exercise using a chair cycle ergometer and anaerobic/calisthenic exercises. The program is supported by a tablet-based application providing guided exercises, real-time monitoring of physiological parameters (heart rate, oxygen saturation, and blood pressure), and feedback. Participants receive prior training on the use of the technology and exercise execution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years Diagnosis of clinically stable heart failure New York Heart Association (NYHA) class I-II Enrollment in a cardiac rehabilitation program Availability of a stable Wi-Fi connection and a smartphone at home Presence of a caregiver trained in the use of the study technology Ability and willingness to provide written informed consent
Key exclusion criteria (1 listed)
- Conditions precluding physical exercise (e.g., bone fractures) Conditions preventing the use of the study technology (e.g., blindness or deafness) Severe cognitive impairment (Six-Item Screener score 0-4) End-stage renal disease requiring dialysis Advanced pulmonary disease Active malignancy Rheumatic disease
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 |
|---|---|---|
| Home-Based Cardiac RehabilitationA home-based cardiac rehabilitation program delivered through the HERE solution, consisting of eight sessions performed twice weekly. The intervention includes aerobic exercise using a chair cycle ergometer and anaerobic/calisthenic exercises. The program is supported by a tablet-based application providing guided exercises, real-time monitoring of physiological parameters (heart rate, oxygen saturation, and blood pressure), and feedback. Participants receive prior training on the use of the technology and exercise execution. | Other | Home-Based Cardiac Rehabilitation (HERE), Hospital-Based Cardiac Rehabilitation |
| Hospital-Based Cardiac RehabilitationA standard hospital-based cardiac rehabilitation program consisting of eight sessions performed twice weekly. The program includes aerobic exercise and anaerobic/calisthenic exercises delivered in the hospital setting under direct supervision by healthcare professionals. | Other | Home-Based Cardiac Rehabilitation (HERE), Hospital-Based Cardiac Rehabilitation |
Primary outcome
Functional Capacity (6-Minute Walk Test)
Time frame: Baseline and Week 4 (within 7 days after the last session)
Functional capacity assessed using the 6-minute walk test (6MWT), defined as the distance walked in meters on a flat surface in 6 minutes. Higher values indicate better functional capacity.
2 secondary outcomes
Adherence to Cardiac Rehabilitation
Time frame: At the end of the rehabilitation program
Quality of Life (KCCQ)
Time frame: Baseline and Week 4 (within 7 days after the last session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Cardiac Rehabilitation and Hospital-Based Cardiac Rehabilitation in people with Heart Failure and Cardiac Rehabilitation, run by Azienda Ospedaliero Universitaria di Sassari 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Apr 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (6-Minute Walk Test) (time frame: Baseline and Week 4 (within 7 days after the last session)). 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 20 Apr 2026.