NCT02106533

Brief Summary

The purpose of the present study was to test the hypothesis that patients with coronary artery disease with lower aerobic fitness exhibit greater responsiveness on improving ventilatory efficiency after aerobic exercise training.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Aug 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

March 27, 2014

Last Update Submit

April 7, 2014

Conditions

Keywords

Coronary artery diseaseExerciseVentilatory efficiency

Outcome Measures

Primary Outcomes (1)

  • Ventilatory efficiency in patients with coronary artery disease

    Measurements of ventilatory efficiency during cardiopulmonary exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs.

    up to 3 months of the interventions

Study Arms (3)

Group 1 peak VO2 <17.5 ml/kg/min

EXPERIMENTAL

The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP.

Other: Aerobic exercise training

Group 2 peak VO2 > 17.5 < 24.5 ml/kg/min

EXPERIMENTAL

The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.

Other: Aerobic exercise training

Group 3 peak VO2 > 24.5 ml/kg/min

EXPERIMENTAL

The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill . Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.

Other: Aerobic exercise training

Interventions

The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.

Group 1 peak VO2 <17.5 ml/kg/minGroup 2 peak VO2 > 17.5 < 24.5 ml/kg/minGroup 3 peak VO2 > 24.5 ml/kg/min

Eligibility Criteria

Age48 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • was stable coronary artery disease diagnosed by coronary angiography

You may not qualify if:

  • unstable angina pectoris,
  • complex ventricular arrhythmias,
  • pulmonary congestion and
  • orthopaedic or neurological limitations to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Prado DM, Rocco EA, Silva AG, Silva PF, Lazzari JM, Assumpcao GL, Thies SB, Suzaki CY, Puig RS, Furlan V. The influence of aerobic fitness status on ventilatory efficiency in patients with coronary artery disease. Clinics (Sao Paulo). 2015 Jan;70(1):46-51. doi: 10.6061/clinics/2015(01)09.

MeSH Terms

Conditions

Coronary Artery DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Study Officials

  • Danilo ML Prado, PHD

    Hospital TotalCor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 8, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2012

Study Completion

May 1, 2013

Last Updated

April 8, 2014

Record last verified: 2014-04