Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction (AMI); Cardiac Rehabilitation

• Registration Number: NCT06807658
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors

Detailed Description

The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors via the following variables: % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits; Adherence to cardiac rehabilitation program; Adherence to pharmacological treatment; Quality of Life improvement ; Anxiety and depression; Satisfaction rate; Functional capacity; Cardiac cause hospitalization; Emergency visits; and Angioplasty revascularization procedure.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-02
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Status Verified: 2025-02
• Study First Posted: 2025-02-04
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Acute myocardial infarct prior to 2 months
• Killip I-II classification
• No previous myocardial infarction
• No angina pectoris
• No ischemia in complementary explorations
• Normal arterial pressure response during stress test.
• No relevant arrythmias
• Left ventricular ejection fraction >= 35%
• Functional capacity >5 METS
• Signing of the inform consent

Exclusion Criteria

• Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program
• Impossibility for digital media use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
% patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits	• (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]	Variable for Cardiovascular Risk Factor Control: Composite Variable Integrating Different Targets for Secondary Prevention in Cardiovascular Disease and Lifestyle Habits; 1. Blood pressure \<140/90 mmHg; 2. Maintaining normal weight or a 5% reduction in body weight if BMI \> 25 kg/m2; 3. Abdominal circumference \<88 cm in women and \<102 cm in men; 4. LDL \<50 mg/dl and a reduction of \>50% in initial LDL levels; 5. Smoking cessation; 6. Adherence to a heart-healthy diet (PREDIMED Questionnaire\* ≥7); 7. Adherence to physical activity level: 6,000-10,000 steps/day or moderate-high IPAQ\*\* result (International Physical Activity Questionnaire)

Secondary Outcome Measures

Name	Time	Method
Adherence to cardiac rehabilitation program	2 months +-30 day	% of patients adherent to cardiac rehabilitation program
Adherence to pharmacological treatment	0-2months +- 30 days-6 months +-7days	Adherence to pharmacological treatment by Morinsky Green Questionnaire, Dichotomous variable: yes means adherent to treatment wich is a better score and no means non adherent to treatment wich is a worse score.
Quality of Life improvement	0-2months +- 30 days-6 months +-7days	Quality of Life by EuroQol-5D questionnaire. EuroQoL-5D index (0-1) 0: Represent the worse state of Health, equivalent to death.; 1: Represents the best state of Health ( no problems in any dimension of the questionnaire).
Anxiety and depression	0-2months +- 30 days-6 months +-7days	Anxiety and depression by Hospital Anxiety and Depression Scale (HADS). HAD Questionnaire: 0-42: Higher values are worse than lower values.
Satisfaction rate	2months +- 30 days	Satisfaction rate with the program, Scale 0-100 (%); 0-100%: Higher values are better than lower values
Functional capacity	0-2months +- 30 days	Functional capacity by cardiac stress test (METS)
Cardiac cause hospitalization	6 months +-7days	Cardiac cause hospitalization
Emergency visits	6 months +-7days	Emergency visits
Angioplasty revascularization procedure	0-2months +- 30 days	Angioplasty revascularization procedure. Further coronary angiography during follow up Yes: is worse No: is better

Trial Locations

Locations (1)

Germans Trias i Pujol University Hospital; 🇪🇸 Badalona, Spain