NCT07870811 Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
| NCT ID | NCT07870811 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Mediterranean Institute for Transplantation and Advanced Specialized Therapies |
| Condition | Heart Transplant Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2026-10-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2026-04-27 with a primary completion date of 2026-10-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07870811 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Heart Transplant Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07870811 currently recruiting?
Yes, NCT07870811 is actively recruiting participants. Contact the research team at gpietrosi@ismett.edu for enrollment information.
Where is the NCT07870811 trial being conducted?
This trial is being conducted at Palermo, Italy.
Who is sponsoring the NCT07870811 clinical trial?
NCT07870811 is sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies. The trial plans to enroll 140 participants.