ClinicalTrials.gg
RecruitingNCT07870811TAOUpdated Nov 5, 2026

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

An interventional study of Acupuncture and Telerehabilitation-Based Physical Rehabilitation in Heart Transplant Patients, Kidney Transplant Patients and Lung Transplant, sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies. Recruiting at 1 site in Italy. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
  • Started Apr 2026; still recruiting 6 months later.
Updated Nov 5, 2026Study completion movedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Transplant Patients
  • Kidney Transplant Patients
  • Lung Transplant
  • Liver Transplanted Patients
03

In context

Lead sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;
  • Absence of clinical 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

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 therapy and/or evidence of ongoing graft rejection;
  • Diagnosis of active ;
  • Pregnancy.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Multidisciplinary program (acupuncture + telerehabilitation + brain health)

    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.

    Procedure: Acupuncture · Behavioral: Telerehabilitation-Based Physical Rehabilitation · Behavioral: Psychological Support Program

  • No intervention
    Standard of care

Interventions

  • ProcedureAcupuncture

    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.

  • BehavioralTelerehabilitation-Based Physical Rehabilitation

    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.

  • BehavioralPsychological Support Program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 6 months

  2. 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.

    Time frame: Baseline to 6 months

  3. 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.

    Time frame: Baseline to 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Apr 2026 to primary completion in Oct 2026, 5 months.

Completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Oct 2027, on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2026
First posted
Oct 13, 2026
StartActual
Apr 27, 2026
Primary completionActual
Oct 21, 2026
CompletionEst.
Oct 21, 2027was Oct 2026
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Study completion
Oct 21, 2026→Oct 21, 2027
Nov 5, 2026
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Nov 5, 2026
    Study completion Oct 21, 2026→Oct 21, 2027
    + 1 other change: verification date
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870811
Lead sponsor
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Apr 27, 2026
Primary completion
Oct 21, 2026
Completion
Oct 21, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Giada Pietrosi
Contact
gpietrosi@ismett.edu
+39 0912192111
Monica Rizzo
Contact
morizzo@ismett.edu
+39 0912192692

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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