A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures
13 septembre 2026 mis à jour par: Dr. Polly Wai-Chi Li, The University of Hong Kong
A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries: A Randomized Sham-controlled Trial
The purpose of this study is to investigate the effects of the frailty-specific prehabilitation program on functional capacity, frailty, cardiac-specific functional status, serum albumin level, high-sensitivity C-reactive protein (hs-CRP) level, HRQoL, psychological outcomes, major adverse cardiovascular and cerebral events (MACCEs), and hospital readmission rates in cardiac patients.
This study tests a home-based prehabilitation program for frail older adults waiting 5+ weeks for heart surgery.
Participants, aged 65+ with mild-to-moderate frailty, receive structured preoperative education, protein-rich nutrition advice, relaxation techniques for stress, and exercise training 3 times weekly via home visits, video calls, and self-practice.
A control group gets sham light stretching plus usual care.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
144
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Polly W.C. Li
- Numéro de téléphone: 852-3917-6686
- E-mail: pwcli@hku.hk
Lieux d'étude
-
-
-
Hong Kong, Hong Kong
- Recrutement
- School of Nursing, The University of Hong Kong
-
Contact:
- Polly W.C. Li
- Numéro de téléphone: 852-3917-6686
- E-mail: pwcli@hku.hk
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Chinese adult patients scheduled for elective CABG, valve repair/replacement, or combined CABG and valve repair/replacement;
- Have mild-to-moderate frailty at the time of recruitment, indicated by a Clinical Frailty Scale score of 4 to 6;
- Have at least 5 weeks of procedural waiting time;
- Are physically fit for prehabilitation as assessed by the surgeon's/cardiologist's using a risk assessment checklist;
- Live with their family;
- Are able to use an electronic device with internet access (patient/family).
Exclusion Criteria:
- Patients with impaired cognition (Abbreviated Mental Test score ≤ 6) or communication, or with physical limitations affecting their ability to exercise
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Frailty-specific prehabilitation program
A comprehensive prerehabilitation program which includes 4 components: 1) structured preoperative education; 2) nutritional optimization; 3) stress management; and 4) exercise training or usual care, respectively.
The prehabilitation will last for at least 4 weeks, continuing throughout the waiting period.
From Week 5 until the day of the surgery, the coach will offer support to encourage the participants to maintain self-practice by prescribing exercises that have previously been learned.
|
A comprehensive prerehabilitation program which includes 4 components: 1) structured preoperative education; 2) nutritional optimization; 3) stress management; and 4) exercise training or usual care, respectively.
The prehabilitation will last for at least 4 weeks, continuing throughout the waiting period.
From Week 5 until the day of the surgery, the coach will offer support to encourage the participants to maintain self-practice by prescribing exercises that have previously been learned.
|
|
Comparateur factice: Attention placebo control
A sham stretching exercise intervention to neutralize the attention effects given by the intervener.
The exercise protocol consists of light-intensity stretching exercises.
The frequency and delivery format will be the same as the prehabilitation for the intervention group, but the duration is shortened to 30-minute per session.
|
A sham stretching exercise intervention to neutralize the attention effects given by the intervener.
The exercise protocol consists of light-intensity stretching exercise involving the upper and lower body, such as neck stretch, shoulder stretch, calf stretch and sited hamstring stretch.
The frequency and delivery format will be the same as the prehabilitation for the intervention group, but the duration is shortened to 30-minute per session
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Functional Capacity
Délai: Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)
|
Short Physical Performance Battery (SPPB) will be used to assess lower limb functional capacity.
It is well validated and has been widely adopted in clinical and research settings.
It consists of three timed-tasks: standing balance, walking speed, and chair-stand.
The timed results will be scaled to a score from 0 to 12, with higher scores indicating better functional capacity.
A hydraulic dynamometer (Jamar) will be used to evaluate grip strength of the dominant hand by maximal isometric contraction, taking the highest reading from at least two trials.
|
Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Frailty Status
Délai: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
|
The Edmonton Frail Scale (EFS) will be used to evaluate the level of frailty.
It consists of nine domains with performance-based and self-reported items scored from 0 to 17, with a higher score indicating a higher level of frailty.
|
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
|
|
Cardiac-specific functional status
Délai: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
The Seattle Angina Questionnaire (SAQ-7) will be used to measure cardiac-related physical functioning.
It has seven items measuring three domains: physical limitation, angina frequency, and disease perception, scored on a 1-5 or 1-6 sequentially coded scale.
Subscale scores are transformed to a scale of 0-100, with higher scores indicating higher levels of functioning and fewer limitations.
|
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
|
Cardiac-specific HRQoL
Délai: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
The MacNew instrument will be used to measure cardiac-specific HRQoL.
It has 27 items scored on a scale of 1-7, and the global score is calculated by summing the item scores, with higher scores representing better HRQoL.
|
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
|
Psychological distress
Délai: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
The Patient Health Questionnaire-4 will be used to measure psychological distress.
It consists of four items assessing anxiety and depression, with responses given on a 4-point Likert scale.
The composite total score ranges from 0 to 12, with higher scores indicating a greater level of anxiety and depression.
|
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
|
Biomarkers (serum albumin)
Délai: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
Serum albumin (g/L) will be assayed according to standard laboratory guidelines in clinical settings
|
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
|
Major adverse cardiovascular and cerebral events (MACCEs) and hospital readmission rates
Délai: From the time of enrollment in the study until 12 months after completing the intervention
|
MACCEs and hospital readmission rates will be monitored from the time of enrollment in the study until 12 months after completing the intervention through the review of the medical records.
MACCEs are defined as an acute myocardial infarction, stroke, heart failure, or any-cause mortality, using diagnosis codes from the International Classification of Diseases, Clinical Modification, tenth Revision.
|
From the time of enrollment in the study until 12 months after completing the intervention
|
|
Biomarker (high-sensitivity C-reactive protein [hs-CRP])
Délai: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
hs-CRP (g/L) will be assayed according to standard laboratory guidelines in clinical settings
|
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 juin 2026
Achèvement primaire (Estimé)
1 avril 2027
Achèvement de l'étude (Estimé)
7 avril 2027
Dates d'inscription aux études
Première soumission
4 juin 2026
Première soumission répondant aux critères de contrôle qualité
13 septembre 2026
Première publication (Réel)
17 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 septembre 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025.526
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .