A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures
13 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
144
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Polly W.C. Li
- Número de teléfono: 852-3917-6686
- Correo electrónico: pwcli@hku.hk
Ubicaciones de estudio
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Hong Kong, Hong Kong
- Reclutamiento
- School of Nursing, The University of Hong Kong
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Contacto:
- Polly W.C. Li
- Número de teléfono: 852-3917-6686
- Correo electrónico: pwcli@hku.hk
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador falso: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional Capacity
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Frailty Status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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])
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de junio de 2026
Finalización primaria (Estimado)
1 de abril de 2027
Finalización del estudio (Estimado)
7 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025.526
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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