Clinical trial NCT02653326: Technological Platforms and Telerehabilitation in Heart Surgery
Official title: Integrative Technological Platforms for Telerehabilitation for Patients With Heart Surgery: A Pilot Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cardiac Surgery
Keywords: Tertiary Prevention
Telerehabilitation
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Hospital Dr. Gustavo Fricke
name: Fundación Dr. Jorge Kaplan Meier
First posted: 2016-01-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation
timeFrame: 4 weeks after randomisation
measure: Exercise Capacity
timeFrame: 8 weeks after randomisation
Secondary outcomes:
measure: Number of Participants With Adverse Events at 4 Weeks
timeFrame: 4 weeks after randomisation
measure: Number of Participants With Adverse Events at 8 Weeks
timeFrame: 8 weeks after randomisation
Other outcomes:
Locations:
city: Vina del Mar
country: Chile
facility: Fundacion Cardiovascular Dr. Jorge Kaplan Meier
state: Valparaiso
city: Viña del Mar
country: Chile
facility: Hospital Gustavo Fricke
state: Valparaíso
Study officials:
affiliation: Universidad de Valparaiso
name: Carla Taramasco, Ph.D.
role: STUDY_DIRECTOR
affiliation: Universidad de Valparaiso
name: Felipe T Martinez, M.D., M.Sc
role: PRINCIPAL_INVESTIGATOR
References: