N/A
N=66
Technological Platforms and Telerehabilitation in Heart Surgery
Cardiovascular Diseases · Cardiac Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02653326 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation — 0.92; 0.87 mL/Kg/minute — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telerehabilitation Monitors (Device); Physical Therapy (Procedure); Nutritional Counseling (Behavioral); Depression Screening (Other); Treatment of Comorbidities (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad de Valparaiso
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation |
0.92; 0.87 | 0.63 |
| PRIMARY Exercise Capacity |
1.0; 0.91 | 0.32 |
| SECONDARY Number of Participants With Adverse Events at 4 Weeks |
0; 0 | — |
| SECONDARY Number of Participants With Adverse Events at 8 Weeks |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02653326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.