At a glance
ClinicalIndex Comparison Record- ✓Adult patients age >18 years
- ✓Recent cardiac surgery within 3 weeks
- ✕Contraindications to physical exercise: unstable angina, acute heart failure, complex ventricular arrhythmias, severe pulmonary hypertension (>60 mmHg), endocavitary thrombuses, recent deep venous thrombosis within 1 month, severe obstructive cardiomyopathy, symptomatic aortic stenosis, or musculoskeletal conditions preventing exercise
- ✕Parkinson's Disease
- ✕Severe dementia or major psychiatric comorbidities that prevent adherence or comprehension of intervention
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Integrative Technological Platforms for Telerehabilitation for Patients With Heart Surgery: A Pilot Randomised Trial
In Brief
A clinical study evaluating Telerehabilitation Monitors, Physical Therapy, and 3 other interventions for Cardiovascular Diseases and Cardiac Surgery. Completed, enrolled 66 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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 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 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.
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.
Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.