A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures
13 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
144
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Polly W.C. Li
- Telefoonnummer: 852-3917-6686
- E-mail: pwcli@hku.hk
Studie Locaties
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Hong Kong, Hongkong
- Werving
- School of Nursing, The University of Hong Kong
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Contact:
- Polly W.C. Li
- Telefoonnummer: 852-3917-6686
- E-mail: pwcli@hku.hk
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Sham-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Functional Capacity
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Frailty Status
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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])
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 juni 2026
Primaire voltooiing (Geschat)
1 april 2027
Studie voltooiing (Geschat)
7 april 2027
Studieregistratiedata
Eerst ingediend
4 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
13 september 2026
Eerst geplaatst (Werkelijk)
17 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
13 september 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025.526
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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