Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients (TAO)
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Giada Pietrosi
- Número de telefone: +39 0912192111
- E-mail: gpietrosi@ismett.edu
Estude backup de contato
- Nome: Monica Rizzo
- Número de telefone: +39 0912192692
- E-mail: morizzo@ismett.edu
Locais de estudo
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Palermo
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Palermo, Palermo, Itália, 90127
- Recrutamento
- IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
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Contato:
- Giada Pietrosi
- Número de telefone: +39 0912192111
- E-mail: gpietrosi@ismett.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Padrão de atendimento
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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. |
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. 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. 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline to 6 Months in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
Prazo: Baseline to 6 months
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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. |
Baseline to 6 months
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Change From Baseline to 6 Months in Psychological Distress Assessed by the Distress Thermometer
Prazo: Baseline to 6 months
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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. |
Baseline to 6 months
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Change From Baseline to 6 Months in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Prazo: 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. |
Baseline to 6 months
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRRB/05/26
Plano para dados de participantes individuais (IPD)
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