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Remote vs In-Person Prehabilitation for Kidney Transplant Candidates (KIDFIT)

2026年7月8日 更新者：Hospital Clinic of Barcelona

Implementation of a Multimodal Prehabilitation Program for Patients With Advanced Chronic Kidney Disease Awaiting Deceased-Donor Kidney Transplantation: A Comparison of In-Person and Remote Delivery Models

Patients with advanced chronic kidney disease awaiting deceased-donor kidney transplantation frequently experience progressive functional decline, frailty, reduced mobility, and poor quality of life while on the transplant waiting list. Although multimodal prehabilitation programs based on exercise, nutritional optimization, and psychological support have shown promising benefits in major surgery, their implementation in kidney transplant candidates remains limited due to barriers related to accessibility, fatigue, transportation, and treatment burden.

This randomized single-center clinical trial aims to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in patients awaiting deceased-donor kidney transplantation, comparing an in-person supervised model with a remote home-based model supported by a digital platform. The primary outcome will be the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include physical activity level, frailty, nutritional status, kidney disease-specific quality of life (KDQOL-36), postoperative recovery quality (QoR-15), postoperative complications, and program adherence.

The study seeks to generate clinically applicable evidence regarding the implementation and scalability of remote prehabilitation strategies in patients with advanced chronic kidney disease, with the potential to improve accessibility, sustainability, and perioperative outcomes in kidney transplantation.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Patients with advanced chronic kidney disease (CKD) awaiting deceased-donor kidney transplantation frequently experience progressive deterioration in functional capacity, mobility, and quality of life during the waiting-list period. Frailty, sarcopenia, cardiovascular comorbidity, anemia, fatigue, and physical inactivity are highly prevalent in this population and may adversely affect perioperative outcomes, postoperative recovery, and healthcare utilization after transplantation. Reduced cardiorespiratory reserve has been associated with increased postoperative morbidity and poorer clinical outcomes in kidney transplant recipients.

Prehabilitation has emerged as a perioperative optimization strategy aimed at enhancing functional reserve before surgical stress through multimodal interventions that combine structured exercise training, nutritional optimization, and psychological support. Previous studies in major surgery and solid organ transplantation suggest that prehabilitation may improve exercise tolerance, physical functioning, postoperative recovery, and patient-reported outcomes. However, implementation of prehabilitation programs in patients with advanced CKD remains limited because of barriers related to dialysis schedules, transportation burden, fatigue, reduced mobility, and limited access to specialized hospital-based programs.

Remote or home-based prehabilitation models supported by digital technologies may improve accessibility, adherence, and scalability while maintaining clinical effectiveness. Nevertheless, evidence comparing remote and in-person multimodal prehabilitation strategies in kidney transplant candidates remains scarce.

This study is a prospective randomized single-center clinical trial designed to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in adult patients with advanced CKD awaiting deceased-donor kidney transplantation. Participants will be randomized in a 1:1 ratio to either an in-person supervised prehabilitation program or a remote home-based program delivered through a digital platform.

Both intervention groups will receive the same multimodal components, differing only in the delivery format. The intervention includes structured individualized exercise training combining aerobic exercise, strength training, mobility, and balance exercises; individualized nutritional counseling focused on optimization of protein-energy status and prevention of sarcopenia; and psychological support aimed at stress management, motivation, and behavioral reinforcement.

During the initial 8-week intervention phase, participants assigned to the in-person group will attend supervised exercise sessions at the hospital gym three times per week. Participants assigned to the remote group will perform supervised online exercise sessions through the Surgifit® digital platform three times per week in small groups. Following completion of the structured phase, both groups will continue with a personalized community-based physical activity program until transplantation.

All participants will receive access to the Surgifit® platform, which provides educational resources, exercise guidance, nutritional recommendations, healthy recipes, and mindfulness activities. The platform will also facilitate monitoring of adherence and remote supervision of exercise sessions.

Functional, nutritional, frailty, psychological, and quality-of-life assessments will be performed at baseline, at 8 weeks, and at 6 months if transplantation has not yet occurred. Postoperative recovery and clinical outcomes will be assessed in patients undergoing transplantation during the study period.

The primary outcome measure of the study is the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcome measures include adherence to the intervention, habitual physical activity level, frailty measures, nutritional status, body composition, kidney disease-specific quality of life, postoperative quality of recovery, postoperative complications, and healthcare utilization outcomes.

The study also incorporates an implementation-oriented framework focused on feasibility, adherence, accessibility, and scalability of multimodal prehabilitation in advanced CKD. Additional exploratory analyses will evaluate patient-perceived barriers and facilitators to participation through questionnaires and qualitative assessments. Environmental and organizational sustainability indicators associated with remote delivery models, including reduction in transportation-related burden and accessibility for patients living far from the transplant center, will also be explored.

The trial is expected to generate clinically applicable evidence regarding the integration of multimodal prehabilitation programs in kidney transplant candidates and to inform future patient-centered and scalable perioperative optimization strategies for patients with advanced chronic kidney disease.

研究の種類

介入

入学 (推定)

84

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Beatriz Tena, MD, PhD
  • 電話番号：+34625193128
  • メール：btena@clinic.cat

研究場所

  • スペイン
    • Barcelona
      • Barcelona、Barcelona、スペイン、08036
        • Hospital Clinic Barcelona
        • コンタクト：
          • Graciela Martínez-Pallí, MD, PhD
          • 電話番号：+34932275558
          • メール：gmartin@clinic.cat
        • 主任研究者：
          • Beatriz Tena, MD, PhD
        • 副調査官：
          • Graciela Martínez-Pallí, MD, PhD
        • 副調査官：
          • Antonio López, MD
        • 副調査官：
          • Fritz Diekman, MD, PhD
        • 副調査官：
          • Alicia Molina, MD
        • 副調査官：
          • Arana Carolt, MD, PhD
        • 副調査官：
          • Marta Arias, MD, PhD
        • 副調査官：
          • Enrique Montagud, MD
        • 副調査官：
          • Mireia Musquera, MD, PhD
        • 副調査官：
          • Fernando Dana, RN
        • 副調査官：
          • Raquel Sebio-Garcia, PT, PhD
        • 副調査官：
          • Anna Yuguero, PT
        • 副調査官：
          • Barbara Romano, RD
        • 副調査官：
          • Miguel Garriz, PsyD
        • 副調査官：
          • Yolanda Amarilla, RN
        • 副調査官：
          • Sonia Perea, RN
        • 副調査官：
          • Ana María Pérez, RN

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Patients with advanced chronic kidney disease on the waiting list for deceased-donor kidney transplantation.
  • Ability to perform moderate-intensity physical exercise.
  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • Absolute contraindication to physical exercise.
  • Severe cognitive impairment limiting participation in the intervention or assessments.
  • Active infection at the time of enrollment.
  • Clinically unstable medical condition.
  • Physical or musculoskeletal limitations preventing participation in the exercise program.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：In-Person Multimodal Prehabilitation
Behavioral: In-Person Multimodal Prehabilitation
行動：In-Person Multimodal Prehabilitation
Participants will receive an 8-week supervised multimodal prehabilitation program including moderate-to-high intensity aerobic exercise, strength training, mobility, and balance exercises performed three times per week at the hospital gym under physiotherapist supervision. The intervention also includes individualized nutritional counseling focused on optimization of protein-energy status and prevention of sarcopenia, as well as psychological support aimed at motivation and stress management. After the supervised phase, participants will continue with a personalized community-based physical activity program until kidney transplantation.
実験的：Remote Multimodal Prehabilitation
Behavioral: Remote Multimodal Prehabilitation
行動：Remote Multimodal Prehabilitation
Participants will receive an 8-week remote multimodal prehabilitation program including supervised online exercise sessions performed three times per week through the Surgifit® digital platform. The exercise program includes aerobic exercise, strength training, mobility, and balance exercises adapted to the participant's functional status. Participants will also receive individualized nutritional counseling and psychological support focused on motivation and stress management. After the supervised phase, participants will continue with a personalized community-based physical activity program until kidney transplantation.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
時間枠：Baseline and 8 weeks
Change in walking distance (meters) between baseline and post-intervention assessment measured using the 6-Minute Walk Test.
Baseline and 8 weeks
Kidney disease-specific quality of life (KDQOL-36)
時間枠：Baseline, 8 weeks, and 6 months
Change in quality-of-life scores measured using the Kidney Disease Quality of Life-36 questionnaire. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life, including fewer kidney disease-related symptoms, less burden of kidney disease, and less interference of kidney disease with daily life.
Baseline, 8 weeks, and 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Program adherence
時間枠：8 weeks
Percentage of scheduled exercise sessions completed during the supervised intervention period.
8 weeks
Physical activity level
時間枠：Baseline, 8 weeks, and 6 months
Physical activity assessed using the Yale Physical Activity Survey (YPAS). The YPAS is a questionnaire designed to assess physical activity levels in older adults. The survey generates summary indices of physical activity, with higher scores indicating greater levels of physical activity. There is no fixed theoretical minimum or maximum.
Baseline, 8 weeks, and 6 months
Functional mobility (Timed Up and Go Test)
時間枠：Baseline, 8 weeks, and 6 months
Functional mobility assessed using the Timed Up and Go Test. It assesses functional mobility by measuring the time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Scores are expressed in seconds, with lower scores indicating better functional mobility and physical performance, and higher scores indicating worse mobility. There is no fixed maximum.
Baseline, 8 weeks, and 6 months
Frailty status
時間枠：Baseline, 8 weeks, and 6 months
Frailty assessed using the Clinical Frailty Scale (CFS). The CFS is a 9-point global measure of frailty ranging from 1 (very fit) to 9 (terminally ill). Higher scores indicate greater frailty and worse overall health status.
Baseline, 8 weeks, and 6 months
Handgrip strength
時間枠：Baseline, 8 weeks, and 6 months
Handgrip strength was measured using a handheld dynamometer and expressed in kilograms (kg). The measure has no fixed minimum or maximum value. Higher values indicate greater muscle strength and generally a better outcome.
Baseline, 8 weeks, and 6 months
Nutritional status
時間枠：Baseline, 8 weeks, and 6 months
Nutritional status assessed according to Global Leadership Initiative on Malnutrition (GLIM) criteria.
Baseline, 8 weeks, and 6 months
Lean body mass
時間枠：Baseline, 8 weeks, and 6 months
Lean Body Mass (%), assessed by bioelectrical impedance analysis (BIA), ranges from 0% to 100%, with higher values indicating a greater proportion of lean tissue relative to total body weight.
Baseline, 8 weeks, and 6 months
Phase angle
時間枠：Baseline, 8 weeks and 6 months
Phase Angle (PhA) was assessed using bioelectrical impedance analysis (BIA) and expressed in degrees (°). The measure has no fixed minimum or maximum value. Higher values indicate better cellular health, membrane integrity, and nutritional status, whereas lower values are associated with poorer nutritional and functional status.
Baseline, 8 weeks and 6 months
Anxiety and depression symptoms
時間枠：Baseline, 8 weeks, and 6 months
Symptoms assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire comprising two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D). Subscale scores range from 0 to 21, and the total score ranges from 0 to 42. Higher scores indicate greater symptoms of anxiety and depression and therefore a worse outcome.
Baseline, 8 weeks, and 6 months
Anxiety related to surgery
時間枠：Baseline, 8 weeks, and 6 months
Preoperative anxiety assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The APAIS is a 6-item questionnaire assessing preoperative anxiety and need for information. The anxiety subscale ranges from 4 to 20, and the information subscale ranges from 2 to 10. The total score ranges from 6 to 30. Higher scores indicate greater preoperative anxiety and/or greater need for information.
Baseline, 8 weeks, and 6 months
Postoperative quality of recovery
時間枠：Postoperative day 5 and postoperative day 30
Quality of postoperative recovery assessed using the Quality of Recovery-15 questionnaire (QoR-15). The QoR-15 is a 15-item patient-reported outcome measure assessing postoperative recovery across multiple domains, including physical comfort, emotional state, physical independence, psychological support, and pain. Total scores range from 0 to 150, with higher scores indicating better quality of recovery and a better postoperative outcome.
Postoperative day 5 and postoperative day 30
Postoperative complications
時間枠：Within 30 days after transplantation
Overall burden of postoperative complications assessed using the Comprehensive Complication Index (CCI).
Within 30 days after transplantation
Lenght of postoperative hospital stay
時間枠：From surgery to hospital discharge, assessed up to 30 days postoperatively.
Length of Postoperative Hospital Stay is defined as the number of days from surgery until hospital discharge. The measure has no fixed minimum or maximum value. Lower values indicate a shorter postoperative hospitalization and generally a better outcome.
From surgery to hospital discharge, assessed up to 30 days postoperatively.
Intensive care unit admission
時間枠：From surgery through hospital discharge, assessed up to 30 days.
Requirement for intensive care unit admission after kidney transplantation during hospital stay.
From surgery through hospital discharge, assessed up to 30 days.
Length of Intensive Care Unit (ICU) Stay
時間枠：From ICU admission to ICU discharge, assessed up to 30 days
Length of Intensive Care Unit (ICU) Stay was defined as the time from ICU admission to ICU discharge and was expressed in days (or hours). The measure has no fixed minimum or maximum value. Lower values indicate a shorter ICU stay and generally a better outcome
From ICU admission to ICU discharge, assessed up to 30 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hospital Clinic of Barcelona

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2028年5月1日

研究の完了 (推定)

2029年5月1日

試験登録日

最初に提出

2026年5月27日

QC基準を満たした最初の提出物

2026年7月8日

最初の投稿 (実際)

2026年7月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月14日

QC基準を満たした最後の更新が送信されました

2026年7月8日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • HCB/2026/0063

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

De-identified individual participant data (IPD) underlying the published results, including demographic, clinical, functional, and patient-reported outcome data collected during the study, may be shared upon reasonable request to the principal investigator after publication of the primary results. Data sharing will be considered for methodologically sound research proposals and following approval by the study investigators and institutional policies. All shared data will be fully anonymized in accordance with applicable data protection regulations. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form may also be made available upon request.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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