Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome

NCT06807658 | Completed

• 1 other identifier: PI-21-286
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myocardial Infarction (AMI); Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits

  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)

  • (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]

Secondary Outcomes (9)

• Adherence to cardiac rehabilitation program

  2 months +-30 day

• Adherence to pharmacological treatment

  0-2months +- 30 days-6 months +-7days

• Quality of Life improvement

  0-2months +- 30 days-6 months +-7days

• Anxiety and depression

  0-2months +- 30 days-6 months +-7days

• Satisfaction rate

  2months +- 30 days

Other Outcomes (1)

• Cost analysis

  6 months +-7days

Study Arms (2)

Tele-rehabilitation

EXPERIMENTAL

Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient is guided via a face-to-face telematic call to perform the cardiac rehabilitation exercises and life style education.

Behavioral: Experimental: Cardiac tele-rehabilitation

In person cardiac rehabilitation

ACTIVE COMPARATOR

Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient attends an in-person cardiac rehabilitation exercises and life style education at the hospital.

Behavioral: Other: Control, in person cardiac rehabilitation

Interventions

Experimental: Cardiac tele-rehabilitation BEHAVIORAL

Patients will connect to their health care provider via a tele-call

Tele-rehabilitation

Other: Control, in person cardiac rehabilitation BEHAVIORAL

Patients will attend an ambulatory cardiac rehabilitation unit

In person cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Germans Trias i Pujol University Hospital

Badalona, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: June 1, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

ES (1)