12-week Exercise-based Program in Myocardial Revascularization Subjects

NCT03643536 | Completed

• 1 other identifier: 2018200801
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if a 12-week physical exercise program (12-WPEP), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) with different left ventricular ejection fraction (LVEF) might improve the health-related quality of life (HRQOL).

Conditions

Quality of Life

Keywords

left ventricular ejection fraction; quality of life

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (HRQOL)

  For the evaluation of health-related quality of life, 36 health survey questionnaire (SF-36) was used. This questionnaire has 36 questions that address two major components based on 8 fields: physical component which includes physical functioning, physical performance, pain and general health, and the mental component which includes vitality, social function, emotional role and mental health.To calculate the score, the items for each one of the eight dimensions are encoded, added and transformed into a scale from 0 (worst health status for this dimension) to 100 (best health status).

  12 weeks after the inclusion

Study Arms (2)

12-WPEP in subjects with reduce LVEF

EXPERIMENTAL

Intervention: a 12 week physical exercise program in the health-related quality of life of CABG or PCI subjects with LVEF by 2D-echocardiography between 30-54%. The quality of life was measured using SF-36 questionnaire

Other: 12-WPEP

12-WPEP in subjects with normal LVEF

ACTIVE COMPARATOR

Intervention: a 12 week physical exercise program in the health-related quality of life of or PCI subjects with LVEF by 2D-echocardiography≥ 55% (control group)The quality of life was measured using SF-36 questionnaire

Other: 12-WPEP

Interventions

12-WPEP OTHER

The 12-WPEP (week physical exercise program) was carried out in 3 sessions each 40 or 60minutes with alternate days per week during 3 months, and with an intensity between 40 to 80 percent of their VO2 max, as the AHA recommends

12-WPEP in subjects with normal LVEF; 12-WPEP in subjects with reduce LVEF

Eligibility Criteria

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

You may qualify if:

• \- CABG or post-PCI subjects and agreed to participate by signing the informed consent form.

You may not qualify if:

• Subjects with musculoskeletal limitations for physical exercise, untreated ventricular arrhythmias, with the presence of residual pericardial effusion, history of intermittent claudication or left ventricular ejection fraction \<30% measured by 2D-echocardiography

Sponsors & Collaborators

• Fundación del Caribe para la Investigación Biomédica: lead

Study Sites (1)

Fundacion del Caribe para la Investigacion Biomedica (Fundacion Bios)

Barranquilla, Atlántico, 080020, Colombia

Location

Study Officials

• Miguel Urina-Triana, PhD ( c)

  Fundacion del Caribe para la Investigacion Biomedica

  STUDY DIRECTOR

• Mirary Mantilla-Morron

  Fundacion del Caribe para la Investigacion Biomedica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective controlled before-after study

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: January 1, 2014
• Primary Completion: December 31, 2014
• Study Completion: March 31, 2015
• Last Updated: August 22, 2018

Record last verified: 2014-01

Locations

CO (1)