Cardiovascular Diseases, Cardiac Surgery
Conditions
Keywords
Tertiary Prevention, Telerehabilitation
Brief summary
In this randomised, double-blind, pilot study, the investigators aim to assess whether a telerehabilitation strategy could improve outcomes among patients with recent heart surgery. Included participants will receive a comprehensive rehabilitation programme comprised of physical therapy, nutritional counselling, psychological assistance in addition to standard medical care. After 12 sessions of physical therapy, patients will be randomised to receive telerehabilitation with a portable EKG device and a smartphone application or usual care. The primary endpoint for this study is the exercise capacity of included participants, which will be assessed using an ergospirometer at 4 and 8 weeks after randomisation.
Detailed description
As in other Latin-american countries, access to rehabilitation programmes is limited, even though their effectiveness has been proved among patients with heart surgery and endorsed in current practice guidelines. In this randomised trial, the investigators aim to assess whether an integrative technological platform might improve the exercise capacity of patients that have undergone heart surgery. Eligible patients include adult (\>18 years old) patients who have undergone any kind of heart surgery in the Hospital Gustavo Fricke between January and December 2016. Patients will be enrolled within 3 weeks of their cardiac surgery into the trial. Patients with any contraindication to physical exercise (see below), Parkinson's disease, severe dementia or psychiatric comorbidities that preclude the initiation of the programme will be excluded. All patients will receive physical training delivered by a group of physical therapists divided in twelve 90-minute sessions. The overall goal of these sessions will be to obtain a workload of 80% - 90% of maximum oxygen consumption (VO2) as established by ergospirometric assessments (Cardiovit CS-200). In addition to exercise, patients will also receive nutritional support, education, risk factor modification and psychological assessments using the Hospital Anxiety and Depression Scale that has been validated in Spanish-speaking countries. Randomisation will be performed by a statistician and study personnel will be kept unaware of the specific method used. Patients in the intervention arm will receive a telerehabilitation strategy comprised by a portable EKG device that will be aimed at establishing heart rate, stress responses and recovery times after physical activities. This sensor will be used to monitor compliance with a prescribed physical therapy programme. In addition, a second sensor will be deployed in the form of a smartphone application that will provide alerts for patients and healthcare providers whenever an adverse event is recorded. The application will also provide motivational messages for participants to optimize adherence to the exercise programme, as well as information regarding individual improvements in physical activities. All patients will undergo an ergospirometry at baseline, 4 weeks and 8 weeks after completion of the initial physical therapy sessions. Clinicians, outcome assessors and analysts well be kept unaware of treatment allocations. All analyses will be undertaken under the intention to treat principle. No prespecified subgroup analyses have been programmed.
Interventions
DEVICETelerehabilitation Monitors
After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
PROCEDUREPhysical Therapy
Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
BEHAVIORALNutritional Counseling
Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
OTHERDepression Screening
Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
DRUGTreatment of Comorbidities
Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.
Sponsors
Hospital Dr. Gustavo Fricke
Fundación Dr. Jorge Kaplan Meier
Universidad de Valparaiso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years old) * Recent cardiac surgery (3 weeks)
Exclusion criteria
* Contraindication to physical exercise (unstable angina, acute heart failure, complex ventricular arrythmias, severe (\>60mmHg) pulmonary hypertension, endocavitary thrombuses, recent deep venous thrombosis (1 month), severe obstructive cardiomyopathy, symptomatic aortic stenosis, musculoskeletal conditions that make exercise impossible) * Parkinsons' Disease * Severe dementia or major psychiatric comorbidities that make adherence or comprehension of the intervention impossible * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation | 4 weeks after randomisation | Ergospirometric assessment of oxygen consumption (VO2) among study participants. |
| Exercise Capacity | 8 weeks after randomisation | Exercise Capacity Assessed as Peak Oxygen Consumption at 8 weeks after randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events at 4 Weeks | 4 weeks after randomisation | Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias. |
| Number of Participants With Adverse Events at 8 Weeks | 8 weeks after randomisation | Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telerehabilitation In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. For information regarding the routine care interventions, please see the routine care description from the control group.
Telerehabilitation Monitors: After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment. | 32 |
| Routine Care Patients allocated to routine care will receive care as enforced by current practice guidelines. Specific interventions include:
Physical Therapy: Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional Counseling: Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression Screening: Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician. | 34 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 7 |
Baseline characteristics
| Characteristic | Routine Care | Total | Telerehabilitation |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 17.1 | 61.4 years STANDARD_DEVIATION 14.5 | 62.0 years STANDARD_DEVIATION 11.3 |
| Alcoholism | 4 Participants | 9 Participants | 5 Participants |
| Body mass index | 26.9 kg/m^2 STANDARD_DEVIATION 3.4 | 27.5 kg/m^2 STANDARD_DEVIATION 3.3 | 28.2 kg/m^2 STANDARD_DEVIATION 3.1 |
| Cancer | 0 Participants | 1 Participants | 1 Participants |
| Chronic obstructive lung disease | 2 Participants | 6 Participants | 4 Participants |
| Diabetes mellitus | 14 Participants | 25 Participants | 11 Participants |
| Dyslipidemia | 12 Participants | 22 Participants | 10 Participants |
| Heart rate at anaerobic threshold | 116.4 beats per minute STANDARD_DEVIATION 18.1 | 116.7 beats per minute STANDARD_DEVIATION 19.8 | 117.1 beats per minute STANDARD_DEVIATION 21.8 |
| Heart rate at rest | 83.0 beats per minute STANDARD_DEVIATION 13.6 | 81.9 beats per minute STANDARD_DEVIATION 13.3 | 80.9 beats per minute STANDARD_DEVIATION 13.2 |
| Heart rate during maximum intensity exercises | 126 beats per minute STANDARD_DEVIATION 22 | 126.4 beats per minute STANDARD_DEVIATION 22.7 | 127.0 beats per minute STANDARD_DEVIATION 23.8 |
| Hypertension | 21 Participants | 48 Participants | 27 Participants |
| Mechanic load at anaerobic threshold | 65.5 watts STANDARD_DEVIATION 29.6 | 64.1 watts STANDARD_DEVIATION 26.4 | 62.6 watts STANDARD_DEVIATION 23.2 |
| Mechanic load during maximum intensity exercises | 81.1 watts STANDARD_DEVIATION 34.2 | 80.9 watts STANDARD_DEVIATION 41.4 | 80.6 watts STANDARD_DEVIATION 48 |
| Oxygen consumption at rest | 0.24 mL/Kg/minute STANDARD_DEVIATION 0.8 | 0.23 mL/Kg/minute STANDARD_DEVIATION 0.8 | 0.23 mL/Kg/minute STANDARD_DEVIATION 0.82 |
| Oxygen consumption during training | 0.78 mL/Kg/minute STANDARD_DEVIATION 0.25 | 0.81 mL/Kg/minute STANDARD_DEVIATION 0.3 | 0.84 mL/Kg/minute STANDARD_DEVIATION 0.36 |
| Peripheral vascular disease | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 23 Participants | 44 Participants | 21 Participants |
| Sleep apnea | 0 Participants | 2 Participants | 2 Participants |
| Smoker | 22 Participants | 46 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 34 |
| other Total, other adverse events | 0 / 32 | 0 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 34 |
Outcome results
Primary
Exercise Capacity
Exercise Capacity Assessed as Peak Oxygen Consumption at 8 weeks after randomisation
Time frame: 8 weeks after randomisation
Population: Outcome assessment after telerehabilitation phase was completed. These are complete-case analyses only. Results using multiple imputation techniques for missing data are given below.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Exercise Capacity | 1.0 mL/Kg/minute | Standard Deviation 0.4 |
| Routine Care | Exercise Capacity | 0.91 mL/Kg/minute | Standard Deviation 0.28 |
p-value: 0.32t-test, 2 sided
Primary
Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation
Ergospirometric assessment of oxygen consumption (VO2) among study participants.
Time frame: 4 weeks after randomisation
Population: Ergospirometric evaluations were conducted after the initial physiotherapy phase was completed amongst study participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation | 0.92 mL/Kg/minute | Standard Deviation 0.39 |
| Routine Care | Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation | 0.87 mL/Kg/minute | Standard Deviation 0.26 |
p-value: 0.63t-test, 2 sided
Secondary
Number of Participants With Adverse Events at 4 Weeks
Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.
Time frame: 4 weeks after randomisation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telerehabilitation | Number of Participants With Adverse Events at 4 Weeks | 0 Participants |
| Routine Care | Number of Participants With Adverse Events at 4 Weeks | 0 Participants |
Secondary
Number of Participants With Adverse Events at 8 Weeks
Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.
Time frame: 8 weeks after randomisation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telerehabilitation | Number of Participants With Adverse Events at 8 Weeks | 0 Participants |
| Routine Care | Number of Participants With Adverse Events at 8 Weeks | 0 Participants |