Technological Platforms and Telerehabilitation in Heart Surgery

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.

Conditions

• Cardiovascular Diseases
• Cardiac Surgery

Interventions

DEVICE

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.

PROCEDURE

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.

BEHAVIORAL

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.

OTHER

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.

DRUG

Treatment of Comorbidities

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

Sponsors & Collaborators

• Hospital Dr. Gustavo Fricke

  collaborator UNKNOWN

• Fundación Dr. Jorge Kaplan Meier

  collaborator UNKNOWN

• Universidad de Valparaiso

  lead OTHER

Principal Investigators

• Carla Taramasco, Ph.D. · Universidad de Valparaiso

• Felipe T Martinez, M.D., M.Sc · Universidad de Valparaiso

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Chile

Study Locations