A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures
13 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
144
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Polly W.C. Li
- Numer telefonu: 852-3917-6686
- E-mail: pwcli@hku.hk
Lokalizacje studiów
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Hong Kong, Hongkong
- Rekrutacyjny
- School of Nursing, The University of Hong Kong
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Kontakt:
- Polly W.C. Li
- Numer telefonu: 852-3917-6686
- E-mail: pwcli@hku.hk
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Pozorny komparator: 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.
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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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Functional Capacity
Ramy czasowe: Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)
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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.
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Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Frailty Status
Ramy czasowe: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
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Cardiac-specific functional status
Ramy czasowe: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Cardiac-specific HRQoL
Ramy czasowe: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Psychological distress
Ramy czasowe: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Biomarkers (serum albumin)
Ramy czasowe: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Serum albumin (g/L) will be assayed according to standard laboratory guidelines in clinical settings
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Major adverse cardiovascular and cerebral events (MACCEs) and hospital readmission rates
Ramy czasowe: From the time of enrollment in the study until 12 months after completing the intervention
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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.
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From the time of enrollment in the study until 12 months after completing the intervention
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Biomarker (high-sensitivity C-reactive protein [hs-CRP])
Ramy czasowe: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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hs-CRP (g/L) will be assayed according to standard laboratory guidelines in clinical settings
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
4 czerwca 2026
Zakończenie podstawowe (Szacowany)
1 kwietnia 2027
Ukończenie studiów (Szacowany)
7 kwietnia 2027
Daty rejestracji na studia
Pierwszy przesłany
4 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 września 2026
Pierwszy wysłany (Rzeczywisty)
17 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
17 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
13 września 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025.526
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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