Heart Transplant PatientsTAONCT07870811
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
A study testing Acupuncture, Telerehabilitation-Based Physical Rehabilitation and Psychological Support Program in people with Heart Transplant Patients and Kidney Transplant Patients, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 1 site in Italy.
Trial summary
This is a single-center interventional study aimed at evaluating the feasibility of a multidisciplinary non-pharmacological approach based on acupuncture, telerehabilitation-based physical rehabilitation, and brain health programs to improve health-related quality of life (HRQoL) and psychophysical well-being in… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Heart Transplant Patients, Kidney Transplant Patients, Lung Transplant
- What is being tested?
- Acupuncture, Telerehabilitation-Based Physical Rehabilitation and Psychological Support Program
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2026to 21 Oct 2027
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 25 years and ≤ 65 years;
- Solid organ transplantation (liver, kidney, heart, or lung) performed at least 1 year prior to enrollment, with good graft functional recovery according to organ-specific criteria;
- Ability to understand and independently complete questionnaires;
- Ability to provide written informed consent;
- Absence of clinical contraindications to therapeutic exercise;
- Adequate cognitive status;
- SF-36 score < 50 or Distress Thermometer (DT) score ≥ 4 and Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.
Who cannot join
- Diagnosis of severe cognitive impairment, acute psychiatric illness, or significant hearing or visual disability;
- Severe ongoing complications or comorbidities that would prevent participation in the physiotherapy program;
- Unstable immunosuppressive therapy and/or evidence of ongoing graft rejection;
- Diagnosis of active malignancy;
- Pregnancy.
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, 1 recruiting
- Recruiting
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
Palermo, Palermo, 90127
Giada Pietrosi, +39 0912192111, gpietrosi@ismett.edu
About this study
Official title: Integrated Multidisciplinary Non-Pharmacological Treatment for Improving Health-Related Quality of Life in Solid Organ Transplant Recipients: A Randomized Single-Center Pilot Study
This is a single-center interventional study aimed at evaluating the feasibility of a multidisciplinary non-pharmacological approach based on acupuncture, telerehabilitation-based physical rehabilitation, and brain health programs to improve health-related quality of life (HRQoL) and psychophysical well-being in patients who have undergone solid organ transplantation (SOT) at least one year earlier, as well as to provide a preliminary estimate of its effects.
Solid organ transplantation (SOT) is currently the most effective treatment, and often the only available option, for end-stage organ failure. Although transplantation can lead to a restitutio ad integrum from a clinical perspective, the quality of life of transplant recipients, regardless of the transplanted organ, frequently remains lower than that of the general population.
This project stems from the clinical, social, and scientific need to provide a concrete response to this challenge through the implementation of functional, reproducible, and economically sustainable rehabilitation pathways aimed at improving HRQoL in solid organ transplant recipients. The proposed approach is based on an innovative multidisciplinary model integrating telerehabilitation, acupuncture, and cognitive stimulation. Such a structured model of care may not only improve patients' quality of life and subjective well-being, but also represent an effective strategy for comprehensive post-transplant management by helping reduce complications, prevent cognitive decline, and promote a more person-centered, sustainable, and humane approach to care.
- Conditions
- Heart Transplant Patients, Kidney Transplant Patients, Lung Transplant, Liver Transplanted Patients
- Being tested
- Acupuncture, Telerehabilitation-Based Physical Rehabilitation, Psychological Support Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
A multidisciplinary non-pharmacological intervention including acupuncture, telerehabilitation-based physical rehabilitation, and psychological support aimed at improving health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients.
Telerehabilitation-Based Physical RehabilitationBehavioural
A multidisciplinary non-pharmacological intervention including acupuncture, telerehabilitation-based physical rehabilitation, and psychological support aimed at improving health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients.
Psychological Support ProgramBehavioural
A multidisciplinary non-pharmacological intervention including acupuncture, telerehabilitation-based physical rehabilitation, and psychological support aimed at improving health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary program (acupuncture + telerehabilitation + brain health) | Experimental | Participants will receive a multidisciplinary non-pharmacological intervention consisting of acupuncture, telerehabilitation-based physical rehabilitation, and psychological support. The intervention is designed to improve health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients at least one year after transplantation. Receives: Procedure: Acupuncture; Behavioral: Telerehabilitation-Based Physical Rehabilitation; Behavioral: Psychological Support Program |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 6 Months in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure is the change in score from baseline to 6 months after randomization.
Measured: Baseline to 6 months
Change From Baseline to 6 Months in Psychological Distress Assessed by the Distress Thermometer
Psychological distress will be assessed using the Distress Thermometer. Scores range from 0 to 10, with higher scores indicating greater psychological distress. The outcome measure is the change in score from baseline to 6 months after randomization.
Measured: Baseline to 6 months
Change From Baseline to 6 Months in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating worse sleep quality. The outcome measure is the change in score from baseline to 6 months after randomization.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start27 Apr 2026
- Primary completion21 Oct 2026
- Study completion21 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870811
- Sponsor's protocol ID
- IRRB/05/26
- Acronym
- TAO
- Status last verified
- Nov 2026
- First submitted
- 1 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Multidisciplinary Non-Pharmacological Treatment for Improving Health-Related Quality of Life in Solid Organ Transplant Recipients: A Randomized Single-Center Pilot Study
- ClinicalTrials.gov ID
- NCT07870811
- Acronym / sponsor ID
- TAO / IRRB/05/26
- Conditions
- Heart Transplant Patients, Kidney Transplant Patients, Lung Transplant, Liver Transplanted Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 21 Oct 2026 (actual)
- Study completion
- 21 Oct 2027 (estimated)
- First posted
- 13 Oct 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 is a single-center interventional study aimed at evaluating the feasibility of a multidisciplinary non-pharmacological approach based on acupuncture, telerehabilitation-based physical rehabilitation, and brain health programs to improve health-related quality of life (HRQoL) and psychophysical well-being in patients who have undergone solid organ transplantation (SOT) at least one year earlier, as well as to provide a preliminary estimate of its effects.
Solid organ transplantation (SOT) is currently the most effective treatment, and often the only available option, for end-stage organ failure. Although transplantation can lead to a restitutio ad integrum from a clinical perspective, the quality of life of transplant recipients, regardless of the transplanted organ, frequently remains lower than that of the general population.
This project stems from the clinical, social, and scientific need to provide a concrete response to this challenge through the implementation of functional, reproducible, and economically sustainable rehabilitation pathways aimed at improving HRQoL in solid organ transplant recipients. The proposed approach is based on an innovative multidisciplinary model integrating telerehabilitation, acupuncture, and cognitive stimulation. Such a structured model of care may not only improve patients' quality of life and subjective well-being, but also represent an effective strategy for comprehensive post-transplant management by helping reduce complications, prevent cognitive decline, and promote a more person-centered, sustainable, and humane approach to care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary program (acupuncture + telerehabilitation + brain health) | Experimental | Procedure: Acupuncture, Behavioral: Telerehabilitation-Based Physical Rehabilitation, Behavioral: Psychological Support ProgramParticipants will receive a multidisciplinary non-pharmacological intervention consisting of acupuncture, telerehabilitation-based physical rehabilitation, and psychological support. The intervention is designed to improve health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients at least one year after transplantation. |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 25 years and ≤ 65 years;
- Solid organ transplantation (liver, kidney, heart, or lung) performed at least 1 year prior to enrollment, with good graft functional recovery according to organ-specific criteria;
- Ability to understand and independently complete questionnaires;
- Ability to provide written informed consent;
- Absence of clinical contraindications to therapeutic exercise;
Key exclusion criteria (5 listed)
- Diagnosis of severe cognitive impairment, acute psychiatric illness, or significant hearing or visual disability;
- Severe ongoing complications or comorbidities that would prevent participation in the physiotherapy program;
- Unstable immunosuppressive therapy and/or evidence of ongoing graft rejection;
- Diagnosis of active malignancy;
- Pregnancy.
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 |
|---|---|---|
| AcupunctureA multidisciplinary non-pharmacological intervention including acupuncture, telerehabilitation-based physical rehabilitation, and psychological support aimed at improving health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients. | Procedure or surgery | Multidisciplinary program (acupuncture + telerehabilitation + brain health) |
| Telerehabilitation-Based Physical RehabilitationA multidisciplinary non-pharmacological intervention including acupuncture, telerehabilitation-based physical rehabilitation, and psychological support aimed at improving health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients. | Behavioural | Multidisciplinary program (acupuncture + telerehabilitation + brain health) |
| Psychological Support ProgramA multidisciplinary non-pharmacological intervention including acupuncture, telerehabilitation-based physical rehabilitation, and psychological support aimed at improving health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients. | Behavioural | Multidisciplinary program (acupuncture + telerehabilitation + brain health) |
Primary outcome
Change From Baseline to 6 Months in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline to 6 months
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure is the change in score from baseline to 6 months after randomization.
Change From Baseline to 6 Months in Psychological Distress Assessed by the Distress Thermometer
Time frame: Baseline to 6 months
Psychological distress will be assessed using the Distress Thermometer. Scores range from 0 to 10, with higher scores indicating greater psychological distress. The outcome measure is the change in score from baseline to 6 months after randomization.
Change From Baseline to 6 Months in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline to 6 months
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating worse sleep quality. The outcome measure is the change in score from baseline to 6 months after randomization.
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 5 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Telerehabilitation-Based Physical Rehabilitation and Psychological Support Program in people with Heart Transplant Patients and Kidney Transplant Patients, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies 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 7 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: looking for participants now, as of the sponsor's last update on 5 Nov 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?
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 Giada Pietrosi (+39 0912192111, gpietrosi@ismett.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 6 Months in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36) (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. 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 5 Nov 2026.