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Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS) (CARDIO-PICS)

2026년 6월 3일 업데이트: Anastasia Toccafondi, Fondazione Don Carlo Gnocchi Onlus

Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS): Impact on Mortality, Rehospitalization, and Clinical-functional Outcomes.

This two-arm, parallel-group randomized clinical trial investigates the effectiveness of an additional telerehabilitation program compared with standard care in patients with Post-Intensive Care Syndrome (PICS). The post-rehabilitation phase is crucial for consolidating recovery and ensuring continuity of care, with telerehabilitation offering a promising tool to enhance long-term adherence and outcomes.

The primary objective is to evaluate whether a structured, multidisciplinary remote rehabilitation program can reduce the risk of rehospitalization and mortality while improving clinical, functional, and psychosocial recovery. Approximately 326 patients aged 30-75 years will be enrolled after inpatient rehabilitation and randomly assigned to either a four-month structured telerehabilitation program or standard post-discharge follow-up.

All participants will undergo assessments at 4 and 12 months to monitor physical, cognitive, psychological, and metabolic recovery, with the ultimate aim of promoting a more complete and sustained rehabilitation after critical illness.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This interventional, two-arm, parallel-group randomized clinical trial aims to evaluate the effectiveness of an additional rehabilitation intervention compared with standard clinical practice in patients affected by Post-Intensive Care Syndrome (PICS). The post-rehabilitation phase represents a critical period for consolidating the therapeutic gains achieved during inpatient rehabilitation and reinforcing the clinical recommendations provided. In this framework, telerehabilitation emerges as a potentially valuable strategy to enhance adherence to post-rehabilitation prescriptions and ensure continuity of care.

The primary objective of the study is to assess whether a structured remote intervention can reduce the risk of rehospitalization and mortality, while improving clinical and functional outcomes across the four key domains of PICS. Specifically, the study will determine whether a multidisciplinary, remotely delivered cardiac telerehabilitation program can promote recovery and decrease the incidence of readmissions or complications among patients previously hospitalized in the Intensive Care Unit.

Following completion of the inpatient rehabilitation program, participants will be randomly allocated to one of two groups: the intervention group will undergo a structured four-month telerehabilitation program, whereas the control group will continue with standard discharge recommendations and conventional follow-up. All participants will be evaluated at 4 and 12 months after discharge to monitor physical, cognitive, psychological, and metabolic outcomes and to assess the long-term effectiveness of the intervention.

A total of approximately 326 patients aged between 30 and 75 years will be enrolled. Participation will be offered to individuals exhibiting signs or symptoms consistent with Post-Intensive Care Syndrome (PICS), with the overall aim of promoting a more complete and sustained recovery following the critical illness phase.

연구 유형

중재적

등록 (추정된)

326

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 이탈리아
    • Milano
      • Milan, Milano, 이탈리아, 20148
        • 모병
        • Fondazione Don Carlo Gnocchi ETS
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Adults aged 30-75 years
  • Previous ICU admission ≥48 hours
  • Presence of Post-Intensive Care Syndrome (PICS), defined as at least one of the following objectively assessed impairments at baseline (T0):
  • Neuromotor impairment, defined as Diagnosis of Critical Illness Myopathy (CIM) or Critical Illness Polyneuropathy (CIP), confirmed by electromyography (EMG)
  • Cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score < 26
  • Psychological impairment, defined as Patient Health Questionnaire-9 (PHQ-9) score ≥ 10
  • Nutritional impairment, defined as the presence of malnutrion according to GLIM criteria, requiring at least one phenotypic criterion (non-volitional weight loss >5% within 6 months or >10% beyond 6 months; BMI <20 kg/m² if <70 years or <22 kg/m² if ≥70 years; reduced muscle mass) and at least one etiologic criterion (reduced food intake or assimilation for >1 week, or any acute/chronic inflammatory burden) and/or presence of sarcopenia assessed by calf circumference <31 cm and reduced muscle strength measured by handgrip strength
  • Metabolic or bone metabolism disorder, defined as altered bone metabolism markers (Bone Turnover Markers outside reference range)

Ability to provide written informed consent

Exclusion Criteria

  • Prognostically unfavorable malnutrition defined as: CONUT score ≥5.
  • Delirium present at the time of the enrollment, documented by a positive Confusion Assessment Method (CAM or CAM-ICU)
  • Pre-existing severe cognitive impairment or dementia, defined as:

documented diagnosis in the medical record prior to ICU admission

- Any clinical condition limiting participation in the rehabilitation program, including: severe orthopedic, neurological, or functional limitations not related to PICS

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Tele-rehabilitation group
Participants will undergo a structured, multidimensional cardiac telerehabilitation program with an integrated approach.
다른: Tele-rehabilitation

A structured, multidimensional telerehabilitation program delivered via the Maia Connected Care platform (AB Medica, MDR class IIa), lasting 16 weeks (4 months), in addition to standard post-rehabilitation care. 1. Synchronous sessions (televisits):

Weeks 1-4:

2 sessions/week (physiotherapy + psychological support)

Weeks 5-16:

1 session/week (alternating physiotherapy and psychological support)

1 session/month (nutritional counseling) 2. Asynchronous rehabilitation program (continuous for 16 weeks): Personalized exercise training (endurance and resistance training) delivered via video-guided modules; Remote monitoring and adaptation by clinicians 3. Cognitive training: Delivered via digital platform (RICORDO-DTx) Multidomain exercises tailored based on baseline MoCA performance

4. Nutritional support: Monthly teleconsultations with a dietitian Monitoring using validated tools (MUST, SARC-F, BIA)
활성 비교기: Standard Care Group
Participants will continue with usual care, receiving standard outpatient rehabilitative treatment according to current clinical practice guidelines.
다른: Standard of Care
Routine clinical care and standard rehabilitative treatment according to current hospital practices.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The Cumulative incidence of all-cause mortality and all-cause rehospitalization
기간: From enrollment to 12 months
This is a composite outcome measure defined as the cumulative incidence of the first occurrence of either death from any cause or hospital readmission for any cause.
From enrollment to 12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Change in six minute walk test
기간: Baseline, 4 months of follow-up, 12 months of follow-up
The 6MWT assesses sub-maximal functional exercise capacity. It measures the distance a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The distance is measured in meters. Higher values represent better functional mobility and endurance. The change is calculated as the 4 months distance minus the baseline distance and the 12 months distance minus the baseline distance.
Baseline, 4 months of follow-up, 12 months of follow-up
Change in Total Body Mass
기간: Baseline, 4 months of follow-up, 12 months of follow-up
Total body mass (weight) is measured in kilograms (kg) using a calibrated digital scale. The change is calculated as the body mass at 4 months of follow-up minus the body mass at baseline and the body mass at 12 months of follow-up minus the body mass at baseline.
Baseline, 4 months of follow-up, 12 months of follow-up
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
기간: Baseline, 4 months of follow-up, 12 months of follow-up.
The KCCQ is a 23-item, self-administered instrument that quantifies physical limitations, symptoms, social limitations, and quality of life in patients with heart failure. The domains are combined into an Overall Summary Score. Scores are transformed to a range from 0 to 100. Higher scores represent a better health-related quality of life and fewer symptoms. The change is calculated as the score at 4 months of follow-up minus the score at baseline and as the score at 12 months of follow-up minus the score at baseline.
Baseline, 4 months of follow-up, 12 months of follow-up.
Change in Urinary Calcium to Creatinine Ratio (24-hour collection)
기간: Baseline (0 months), 4 months, and 12 months
This ratio evaluates calcium excretion normalized by creatinine levels in 24-hour urine collection to assess bone resorption and mineral metabolism. Measured in mg/mg (or mmol/mmol). The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline (0 months), 4 months, and 12 months
Change in 24-Hour Creatinine Clearance
기간: Baseline, 4 months, and 12 months.
A measure of glomerular filtration rate (GFR) calculated from 24-hour urine volume, urine creatinine, and serum creatinine levels to assess renal function. Measured in mL/min. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Serum Osteocalcin Levels
기간: Baseline, 4 months, and 12 months.
A biochemical marker of bone formation reflecting osteoblastic activity. Measured in ng/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Intact Parathyroid Hormone (PTH) Levels
기간: Baseline, 4 months, and 12 months.
A key regulator of calcium and phosphate metabolism. Measured in pg/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Serum C-terminal Telopeptide of Type I Collagen (CTX)
기간: Baseline, 4 months, and 12 months.
A specific marker of bone resorption reflecting osteoclast activity. Measured in ng/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Thyroid-Stimulating Hormone (TSH) Levels
기간: Baseline, 4 months, and 12 months.
Assessment of thyroid function, which can influence bone turnover rates. Measured in µIU/mL. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
Change in Bone-Specific Alkaline Phosphatase (BsALP)
기간: Baseline, 4 months, and 12 months.
An isoenzyme of alkaline phosphatase that serves as a specific marker for bone formation and osteoblast activity. Measured in µg/L. The change is measured as the value at 4 months minus the value at baseline and as the value at 12 months minus the value at baseline.
Baseline, 4 months, and 12 months.
The cumulative incidence of Major Adverse Cardiovascular Events
기간: From enrollment to 6 and 12 months
MACE is defined as a composite endpoint consisting of the first occurrence of any of the following: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
From enrollment to 6 and 12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fondazione Don Carlo Gnocchi Onlus

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 13일

기본 완료 (추정된)

2028년 10월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 2월 13일

QC 기준을 충족하는 최초 제출

2026년 5월 14일

처음 게시됨 (실제)

2026년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 3일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Cardio-PICS
  • Post-critical and Heart (기타 식별자: Fondazione Don Gnocchi ETS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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