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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Giada Pietrosi
- 전화번호: +39 0912192111
- 이메일: gpietrosi@ismett.edu
연구 연락처 백업
- 이름: Monica Rizzo
- 전화번호: +39 0912192692
- 이메일: morizzo@ismett.edu
연구 장소
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Palermo
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Palermo, Palermo, 이탈리아, 90127
- 모병
- IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
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연락하다:
- Giada Pietrosi
- 전화번호: +39 0912192111
- 이메일: gpietrosi@ismett.edu
-
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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간섭 없음: 치료의 표준
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
기간: 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
기간: 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)
기간: Baseline to 6 months
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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
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공동 작업자 및 조사자
스폰서
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- IRRB/05/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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