A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures
NCT ID: NCT06323317
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-12-18
2025-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Frailty-Specific Prehabilitation Program
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.
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.
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.
Routine Preoperative Care
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
2. With physical limitations to exercise
18 Years
ALL
Yes
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Polly Wai-Chi Li
Assistant Professor
Principal Investigators
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Polly Li, Dr
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong, School of Nursing
Locations
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Polly Wai Chi
Hong Kong, Please Select, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UW 21-405
Identifier Type: -
Identifier Source: org_study_id
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