Technological Platforms and Telerehabilitation in Heart Surgery

NCT ID: NCT02653326

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Cardiovascular Diseases; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutritional Counseling

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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.

Treatment of Comorbidities

Intervention Type: DRUG

Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.

Telerehabilitation Monitors

Intervention Type: DEVICE

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.

Physical Therapy

Intervention Type: PROCEDURE

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.

Routine Care

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.

Group Type: ACTIVE_COMPARATOR

Nutritional Counseling

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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.

Treatment of Comorbidities

Intervention Type: DRUG

Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.

Physical Therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Treatment of Comorbidities

Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Dr. Gustavo Fricke

UNKNOWN

Sponsor Role: collaborator

Fundación Dr. Jorge Kaplan Meier

UNKNOWN

Sponsor Role: collaborator

Universidad de Valparaiso

OTHER

Sponsor Role: lead

Responsible Party

Felipe Martinez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla Taramasco, Ph.D.

Role: STUDY_DIRECTOR

Universidad de Valparaiso

Felipe T Martinez, M.D., M.Sc

Role: PRINCIPAL_INVESTIGATOR

Universidad de Valparaiso

Locations

Fundacion Cardiovascular Dr. Jorge Kaplan Meier

Viña del Mar, Región de Valparaíso, Chile

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Countries

Chile

Other Identifiers

CEC093-15

Identifier Type: -

Identifier Source: org_study_id