Frailty, Thoracic Surgery
Conditions
Keywords
Prehabilitation, CABG, valve repair/replacement
Brief summary
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.
Interventions
BEHAVIORALFrailty-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.
BEHAVIORALA sham stretching exercise intervention
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
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frailty Status | 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. |
| Cardiac-specific functional status | 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. |
| Cardiac-specific HRQoL | 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. |
| Psychological distress | 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. |
| Biomarkers (serum albumin) | 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 |
| Major adverse cardiovascular and cerebral events (MACCEs) and hospital readmission rates | 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. |
| Biomarker (high-sensitivity C-reactive protein [hs-CRP]) | 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 |
Countries
Hong Kong
Contacts
CONTACTPolly W.C. Li
Outcome results
None listed