A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures

Frailty Clinical Trial

— PREHAB  

Official title:

The Feasibility and Triability of a Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323317
• Other study ID #: UW 21-405
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: The University of Hong Kong
• Contact: Polly Li, Dr
• Phone: 852-39176686
• Email: pwcli[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cardiovascular disease is a major cause of disability and morbidity worldwide. With advances in medical technology and care, patients with cardiovascular disease often live to an advanced age. In the older cohort, conditions particularly associated with age-related atherosclerosis and calcification dominate, such as coronary artery disease and valvular heart disease. Surgical interventions remain the treatment-of-choice for patients with advanced cardiac conditions. However, this vulnerable cohort is still afflicted by a higher risk of mortality, postoperative complications, and longer hospital stays, particularly those with frailty.

Frailty is a clinical condition characterized by reduced reserve capacity and excessive vulnerability to increased risk of adverse health outcomes when exposed to stressors. Its prevalence increases in the population with cardiovascular disease and is a significant prognostic indicator for predicting postoperative outcomes in cardiac patients. The best strategy to minimize the prognostic impacts of frailty on cardiac patients should be intervened at the preoperative stage, which may be achieved through prehabilitation.

Prehabilitation refers to preoperative interventions designed to optimize patients' physical and psychological readiness for surgery. The international guidelines of the Enhanced Recovery After Surgery Society (ERAS) suggest the prehabilitation for cardiac surgical patients should be exercise-based, supplemented with education, dietary modification, and psychological support. These components can prepare patients to withstand stressful events during surgery through reducing sympathetic over-activity and improving their physiological and functional capacities.

Accumulating evidence indicates the effectiveness of prehabilitation for general cardiac patients through respiratory muscle and aerobic training; however, few studies have investigated those with frailty, who are in greater need. Among the limited trial that particularly focus on frail patients, encouraging findings have been reported that preliminarily indicate their efficacy and safety profile. There are also some ongoing trials testing prehabilitation for frail cardiac patients registered in trial registries.

Despite the promising results, there are several major knowledge gaps in the studies of prehabilitation for frail cardiac patients. First, most of these trials are testing a single frailty-reversing strategy, either nutritional or exercise interventions, which are less comprehensive to address the urgent needs of surgical patients. Second, the protocols of those exercise programs are mainly aerobic-focused, deviating from the principles of exercise prescription suggested for frailty management. Third, all completed and ongoing trials are center-based using gymnasium equipment, which has several limitations that jeopardize the feasibility, availability, and effectiveness of the programs.

To conclude, more comprehensive and accessible prehabilitation programs are needed for frail cardiac patients to address their complex needs and improve their surgical outcomes. A hybrid approach, using eHealth to supplement in-person patient support, could offer a more practical and feasible solution. Further research is required to develop and evaluate such programs and to fill the knowledge gaps in prehabilitation for frail cardiac patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. A confirmed schedule for elective CABG, valve repair/replacement, or combined CABG and valve repair/replacement, or TAVI

2. Mild to moderate frailty at the time of recruitment, indicated by a Clinical Frailty Scale score between 4 and 6

3. At least 5 weeks of procedural waiting time

4. Physically fit for prehabilitation according to the surgeon/cardiologist's endorsement on a risk-assessment checklist

5. Living with family

6. Using an electronic device with internet access (patient/family).

Exclusion Criteria:

1. Impaired cognition (Abbreviated Mental Test score =6) or communication

2. With physical limitations to exercise

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Multi-component exercise programme
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.

Other:
• Attention Placebo
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.

Behavioral:
• Structured preoperative education
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.
• Nutritional optimization
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.
• Stress management
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.

Locations

Country	Name	City	State
Hong Kong	Polly Wai Chi	Hong Kong	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	The Hospital Anxiety and Depression Scale (HADS)	It is used to measure anxiety and depression. It has 14 items in two subscales scored on a 4-point Likert scale, with higher scores indicating a more intensive anxious and depressed mood. It has good internal consistency and concurrent and criterion validity.	At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)
Secondary	Biomarkers-Serum albumin	Serum albumin count (mg/dL) will be collected according to standard laboratory guidelines in the clinical setting.	At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)
Secondary	Biomarkers- C-reactive protein	C-reactive protein count (mg/L) will be collected according to standard laboratory guidelines in the clinical setting.	At baseline (T0), one-day before surgery (T1), postoperative 1 month (T2), and postoperative 3 months (T3)
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)	Document through record review	Monitored from Day 0 to 3 months postoperative through record review
Secondary	Hospital Length of stay	Document through record review	Monitored from Day 0 to 3 months postoperative through record review
Secondary	Hospital Readmissions	Document through record review	Monitored from Day 0 to 3 months postoperative through record review