A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures

NCT06323317 | Recruiting

• 1 other identifier: UW 21-405
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures. The program aims to improve functional capacity, frailty level, cardiac-related physical functioning, health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE), hospital length of stay, and readmission rates. Cardiovascular disease is a leading cause of disability and morbidity globally, particularly in older adults. Frailty, a geriatric syndrome commonly seen in cardiac patients, complicates their perioperative care and leads to worse outcomes. Prehabilitation, which optimizes patients' physiological and functional capacities before surgery, has shown promise in general cardiac patients but requires a more comprehensive approach for frail individuals. This randomized controlled trial will recruit 50 Chinese adults awaiting elective cardiac surgeries/procedures in Hong Kong. Participants will be randomly assigned to either the intervention group, receiving a comprehensive prehabilitation program, or the control group, receiving routine preoperative care. Assessments will be conducted at baseline and at three postoperative time points. The findings will contribute to our understanding of the impact of frailty on postoperative outcomes and help develop strategies to improve patient care. Ultimately, this study aims to reduce healthcare burdens associated with cardiac disease-related morbidity and disability.

Conditions

Coronary Artery Bypass Grafting; Heart Valve Replacement; Transcatheter Aortic Valve Implantation; Frailty

Keywords

prehabilitation; home-based exercise; centre-based exercise; coronary artery bypass grafting; valve replacement; valve repair; transcatheter aortic valve implantation; cardiac patients

Outcome Measures

Primary Outcomes (8)

• The Short Physical Performance Battery (SPPB)

  It is used to assess functional capacity. A brief performance-based assessment consisting of 3 timed-tasks, namely standing balance, walking speed, and chair stand tests. The timed results will be rescaled to obtain a score ranging from 0 to 12, with higher scores indicating better functional status.

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Weakness/ Grip Strength (Fried Phenotype Frailty Assessment)

  (For Outcome measures 2 to 6): Fried Phenotype Frailty Assessment consists of five domains (Outcome 2 to Outcome 6). If the aggregated score is (3-5), the subject is classified as being frail. Fried Phenotype Frailty Assessment is a valid, reliable, and commonly used tool for assessing frailty. Weakness is measured by the maximal grip strength (kilograms) in the dominant hand (3 measures averaged), using a hand-held dynamometer. This criterion is met if grip strength is measured at the lowest 20% at baseline, adjusted for gender and body mass index.

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Slowness (Fried Phenotype Frailty Assessment)

  Slowness is measured by using the 5-meter walking test. This criterion is met for the slowest 20% of the population at baseline, based on the time to walk 5 metres, adjusting for gender and standing height.

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Low Physical Activity (Fried Phenotype Frailty Assessment)

  The Minnesota Leisure Time Activities Questionnaire is used to measure physical activities in the prior 2 weeks, plus frequency and duration. Physical function was measured by asking about difficulty with 15 tasks of daily life, including mobility, upper extremity, instrumental activities of daily living (IADL). A weighted score of kilocalories expended per week was calculated at baseline based on each participant's report. This criterion is met if the kilcalories expenditure is below the cut-off values as described by Fried and colleagues (men 383 kcal/week, women 270 kcal/week).

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Self-reported Exhaustion (Fried Phenotype Frailty Assessment)

  Exhaustion is measured by using two items from the Center for Epidemiological Studies Depression scale: "How often did you feel that everything you did was an effort?" and "How often did you feel that you could not get going?" This criterion was met when participants answered: "always or most of the times" to at least one of the two questions.

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Unintentional Weight Loss (Fried Phenotype Frailty Assessment)

  Weight loss is measured by calculating if the subject has lost at least 5 percent of previous year' body weight unintentionally (i.e. not due to dieting or exercise). This criterion is met if unintentional weight loss ≥ 5 percent.

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• The Seattle Angina Questionnaire (SAQ)

  It is used to measure cardiac-related functional status. It has 19 items in 5 subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. It is scored on a 1-5 or 6 sequentially coded scale, and subscale scores are transformed to a scale of 0-100, with higher scores indicating higher levels of functioning and fewer limitations. The Chinese version has been shown to be reliable, valid, and sensitive to clinical change.

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• The MacNew Heart Disease Health-Related Quality of Life Questionnaire

  The MacNew will be used to measure cardiac-specific HRQoL. It has 27 items scored on a 1-7 Likert scale, ranging from "all of the time" to "some of the time", with higher score representing better HRQoL. A global score is then calculated by averaging the item scored (from 1-7), with higher scores also representing better HRQoL. MacNew has good internal consistency, test-retest reliability, and concurrent and discriminant validity.

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

Secondary Outcomes (6)

• The Hospital Anxiety and Depression Scale (HADS)

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Biomarkers-Serum albumin

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Biomarkers- C-reactive protein

  At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)

• Major adverse cardiac and cerebrovascular events (MACCE)

  Monitored from Day 0 to 3 months postoperative through record review

• Hospital Length of stay

  Monitored from Day 0 to 3 months postoperative through record review

Study Arms (2)

Frailty-Specific Prehabilitation Program

EXPERIMENTAL

Participants in the frailty-specific prehabilitation program (intervention group) will participate in a comprehensive prehabilitation programme comprising the following components: 1) structured preoperative education; 2) nutritional optimization; 3) stress management; and 4) exercise training. These four components are recommended by the international association as core elements of prehabilitation to optimize cardiac patients' physical and psychological capacity to withstand the challenges of cardiac surgical procedures. The prehabilitation will last for at least 4 weeks, and it will continue throughout the preoperative period.

Behavioral: Multi-component exercise programme; Behavioral: Structured preoperative education; Behavioral: Nutritional optimization; Behavioral: Stress management

Routine Preoperative Care

PLACEBO COMPARATOR

Participants in the control group will receive routine preoperative care provided by the clinical team, which includes unstructured patient education on the surgeries/procedures, and a brief session on the use of an incentive spirometer, breathing, and coughing exercise. Other perioperative care procedures will be implemented according to the existing clinical protocols.

Other: Attention Placebo

Interventions

Multi-component exercise programme BEHAVIORAL

Each exercise session will start with a warm-up, followed by core exercise training and ending with a cool-down period. A series of flexibility training and stretching exercises will be performed during the warm-up and cool-down phases (10 minutes in total). The core exercise session will comprise aerobic (10 minutes), resistance (20 minutes), and balance (20 minutes) training, where resistance and balance exercises constitute the major components, as they are particularly effective in strengthening functional capacity, muscle strength, and balance function for mobility in frail patients.

Frailty-Specific Prehabilitation Program

Attention Placebo OTHER

The control group will receive routine preoperative care provided by the clinical team, which includes unstructured patient education on the surgeries/procedures, and a brief session on the use of an incentive spirometer, breathing, and coughing exercise. Other perioperative care procedures will be implemented according to the existing clinical protocols.

Routine Preoperative Care

Structured preoperative education BEHAVIORAL

The prehabilitation programme will begin with a 60-minute (group- or individual-based) structured education session at the centre. The content will cover frailty, its impacts on postoperative recovery, cardiovascular and overall health, and functional well-being. The importance of nutrition and exercise on their recovery potential and postoperative functional capacity will be elaborated. Their commitment to intervention engagement will be highlighted as the key to success. This session will also cover the principles of exercise, its progression, and exercise safety.

Frailty-Specific Prehabilitation Program

Nutritional optimization BEHAVIORAL

The Malnutrition Universal Screening Tool (MUST) will be used for a nutritional screening to determine the risk of malnutrition (low, medium, or high). The nurse will evaluate the dietary patterns of each participant, and provide tailored nutritional advice on daily protein intake according to a protein supplementation protocol. The participants and their caregivers will be provided with plenty of suggestions for high-quality protein foods according to patients' preferences. The nurse will follow-up with the participants to identify any barriers they encountered in real-world settings when they attend the exercise sessions. She will reinforce the advice and provide suggestions to overcome barriers according to the preference and lifestyle of the participants.

Frailty-Specific Prehabilitation Program

Stress management BEHAVIORAL

Relaxation techniques to reduce tense arousal, including guide imagery and breathing techniques, will be taught. Guided imagery makes use of attention-focus to target mental arousal, whereas deep and diaphragmatic breathing is a fundamental relaxation method for various stress relieving techniques. Both techniques are designed to reduce sympathetic arousal, which is particularly beneficial to cardiac patients. Participants will be encouraged to self-practice on a daily basis, and a sound track will be provided to guide their practice.

Frailty-Specific Prehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A confirmed schedule for elective CABG, valve repair/replacement, or combined CABG and valve repair/replacement, or TAVI
• Mild to moderate frailty at the time of recruitment, indicated by a Clinical Frailty Scale score between 4 and 6
• At least 5 weeks of procedural waiting time
• Physically fit for prehabilitation according to the surgeon/cardiologist's endorsement on a risk-assessment checklist
• Living with family
• Using an electronic device with internet access (patient/family).

You may not qualify if:

• Impaired cognition (Abbreviated Mental Test score ≤6) or communication
• With physical limitations to exercise

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Polly Wai Chi

Hong Kong, Please Select, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Polly Li, Dr

  The University of Hong Kong, School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Polly Li, Dr

CONTACT

852-39176686; pwcli@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The post-intervention data collector (research assistant) will be blinded to the group allocation to avoid performance and detection biases.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 21, 2024
• Study Start: December 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)