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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02653326 |
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Date of registration:
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08/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Technological Platforms and Telerehabilitation in Heart Surgery
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Scientific title:
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Integrative Technological Platforms for Telerehabilitation for Patients With Heart Surgery: A Pilot Randomised Trial |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02653326 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Chile
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Contacts
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Name:
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Carla Taramasco, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de Valparaiso |
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Name:
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Felipe T Martinez, M.D., M.Sc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de Valparaiso |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiac Surgery
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Cardiovascular Diseases
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Intervention(s)
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Behavioral: Nutritional Counseling
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Procedure: Physical Therapy
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Drug: Treatment of Comorbidities
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Other: Depression Screening
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Device: Telerehabilitation Monitors
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Primary Outcome(s)
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Exercise Capacity
[Time Frame: 8 weeks after randomisation]
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Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation
[Time Frame: 4 weeks after randomisation]
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Secondary Outcome(s)
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Number of Participants With Adverse Events at 4 Weeks
[Time Frame: 4 weeks after randomisation]
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Number of Participants With Adverse Events at 8 Weeks
[Time Frame: 8 weeks after randomisation]
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Secondary ID(s)
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CEC093-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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