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RECRUITING Not applicable ClinicalTrials.gov

Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients

Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies • ClinicalTrials.gov ID: NCT07870811

Registry updated: 2026-10-13
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Description

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.

Interventions

  • Acupuncture (Procedure)
    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 Rehabilitation (Behavioral)
    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 Program (Behavioral)
    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.

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.

Conditions

Heart Transplant Patients Kidney Transplant Patients Lung Transplant Liver Transplanted Patients

Locations

  • IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione — Palermo, Palermo, Italy
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record