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Low-risk cardiac rehabilitation in everyday life environments with the help of web technology and mobile apps: might it be as effective as face-to-face rehabilitation at hospital?

Implementation and evaluation of a telemedicine-based service to support "e-supervised" regime in Phase II Cardiac Rehabilitation Programs: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18022985
Enrollment
256
Registered
2020-12-07
Start date
2014-10-01
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac rehabilitation Circulatory System

Interventions

Both groups follow a phase II cardiac rehabilitation program, they are monitored for 8 weeks Intervention group supervision is by the telemedicine system Control group have on-site supervision in the
psychological (anxiety control, relaxation)
education in cardiovascular risk factor control (medication, life habits)
return to work
sexual dysfunction
among others. The activities are prog

Sponsors

Hospital Universitario Ramón y Cajal
Lead Sponsor
Instituto de Salud Carlos III
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients requiring phase II cardiac rehabilitation at the center due to ischemic heart disease (myocardial infarction, percutaneous or surgical revascularization); operated valvular heart disease or mixed heart surgery 2. Patients able to commit to the demands of the trial: the ability to understand, read and write the Spanish language, cognitive and manual ability to use the technological devices intended for the study 3. Patients who agree to participate in the study (sign oral or written informed consent) 4. Patients who have internet access at home

Exclusion criteria

Exclusion criteria: 1. Severe injury of three vessels not appropriate for revascularization 2. Angina/severe ischemia in provocation tests 3, Severe arrhythmia 4. Severe Left ventricle disfunction (EF 75 years 8. Any type of physical or mental disability that prevents the use of technological devices in the system and not have family support or otherwise

Design outcomes

Primary

MeasureTime frame
Functional capacity in METs (metabolic equivalent), measured using the measured MET exercise test (ramp protocol), at baseline and the end of stage 1 (final phase II cardiac rehabilitation program)

Secondary

MeasureTime frame
Measured at baseline, week 8 and week 60: 1. Improvement in functional capacity in METs measurement by exercise testing (ramp protocol) at the end of the study (first year of Phase III). From exercise testing also: clinical (positive / negative) response; electrical response (positive /negative / not assessable); significant arrhythmias (atrial / ventricular); heart rate (basal/submaximal-60%/submaximal-80%/end/first minute of recovery). 2. Left ventricle Ejection fraction (echocardiogram). Cardiovascular risk factors: smoking (defined by smoking at enrollment); LDL cholesterol levels above 100 mg / dl; hypertension (defined as greater than 140 mm / Hg systolic or 90 mm / Hg in diastolic blood pressure 130 and 80 mm / Hg in diabetics or antihypertensive drugs); glucose, glycated Hb. 3. Psychological information: 3.1. Beck (depression) 3.2. STAI (anxiety) 3.3. Quality of life (EQ-5D-5L) 3.4. Individualized treatment (psychological / psychiatric). 4. Employment information: nature of work (white collar, blue collar, self employed, time of return to work in days) measured using self-report 5. Complications (angina, reinfarction, arrhythmias, heart failure, need for revascularization), mortality (cardiac or due to other causes) measured using patient records 6. Motivation by the program (self-reported Likert scale of 5 points between "high" and "very low"). 7. Self-reported satisfaction with the program at the end of the study (Likert scale of 5 points between "high" and "very low") 8. Usability of the system (System Usability Scale)

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026