Technological Platforms and Telerehabilitation in Heart Surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery; Cardiovascular Diseases
• Interventions: Device: Telerehabilitation Monitors; Procedure: Physical Therapy; Behavioral: Nutritional Counseling; Other: Depression Screening; Drug: Treatment of Comorbidities

• Registration Number: NCT02653326
• Lead Sponsor: Universidad de Valparaiso

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-09
• Study First Posted: 2016-01-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-12-11
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Results First Posted: 2019-01-28
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Adult patients (>18 years old)
• Recent cardiac surgery (3 weeks)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	Physical Therapy	In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application.
Telerehabilitation	Telerehabilitation Monitors	In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application.
Routine Care	Depression Screening	Patients allocated to routine care will receive care as enforced by current practice guidelines. This care included nutritional counseling, depression screening, drug therapy for the management of comorbidities and physical exercise without telemonitoring.
Telerehabilitation	Depression Screening	In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application.
Telerehabilitation	Treatment of Comorbidities	In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application.
Routine Care	Physical Therapy	Patients allocated to routine care will receive care as enforced by current practice guidelines. This care included nutritional counseling, depression screening, drug therapy for the management of comorbidities and physical exercise without telemonitoring.
Routine Care	Nutritional Counseling	Patients allocated to routine care will receive care as enforced by current practice guidelines. This care included nutritional counseling, depression screening, drug therapy for the management of comorbidities and physical exercise without telemonitoring.
Routine Care	Treatment of Comorbidities	Patients allocated to routine care will receive care as enforced by current practice guidelines. This care included nutritional counseling, depression screening, drug therapy for the management of comorbidities and physical exercise without telemonitoring.
Telerehabilitation	Nutritional Counseling	In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

Hospital Gustavo Fricke; 🇨🇱 Viña del Mar, Valparaíso, Chile

Fundacion Cardiovascular Dr. Jorge Kaplan Meier; 🇨🇱 Vina del Mar, Valparaiso, Chile