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OpenTrials
Completed

NCT Number: NCT01977742

Rest-exercise Transition Training to Improve Cardiac Vagal Tone

Purpose: to investigate the hypothetical additive value of a sudden rest-exercise training over the cardiac vagal of cardiac patients in a supervised exercise program.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Allocating in the admission for a supervised exercise program all subjects evaluated with low cardiac vagal tone (cardiac vagal index ≤ 1,30), it is expected that from a sample of almost 150 subjects (all over 18 years-old, ranging mostly from 40 to 50), we will compare 50 subjects that adhered to the supervised exercise program ( more than 65% of expected presence). Patients with pacemaker on unable to exercise in the bicycle will be excluded from the study, as well as those who does not adhere to at least more than 65% of the expected presence in the supervised exercise program.

All the sample will be randomized to performed 8 weeks of a specific sudden rest-exercise training and after 8 weeks will discontinue the protocol, or will do the opposite ( 8 weeks of no specific protocol, followed by 8 weeks of specific sudden rest-exercise training). The cardiac vagal will be evaluated at every 8 weeks to measure the cardiac vagal index between both phases. During all the time, all clients will perform aerobic, strength and flexibility exercises as part of the supervised exercise program.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cardiac vagal index ≤ 1,30

Exclusion criteria

  • pacemaker
  • low adherence
  • cognitive/physical impairment

Treatment and study plan

Supervised exercise program

Other

Aerobic, strength and flexibility exercises in a supervised exercise program for 8 weeks; after 8 weeks will add a specific sudden rest-exercise training protocol, three times a week. The cardiac vagal index will be measured at every 8 weeks.

Supervised exercise program together with a specific sudden rest-exercise training protocol

Other

Aerobic, strength and flexibility exercises in a supervised exercise program for 8 weeks together with a specific sudden rest-exercise training protocol, three times a week After 8 weeks will discontinue the specific sudden rest-exercise training protocol. The cardiac vagal index will be measured at every 8 weeks.

Primary outcomes

  1. Supervised exercise program and rest-exercise transition training to improve cardiac vagal tone

    Time frame: 16 weeks

    Cardiac vagal tone after either 8 weeks of aerobic, strength and flexibility exercises alone or 8 weeks of aerobic, strength, flexibility exercises combined with specific sudden rest-exercise training

Secondary outcomes

  1. Longitudinal effects of supervised exercise program and rest-exercise transition training to improve cardiac vagal tone

    Time frame: 1 year

    Cardiac vagal tone measures at every 8 weeks after both phases (16 weeks of training / no training, depending of the randomization) during a year

Sponsors and collaborators

Lead sponsor

Clínica de Medicina do Exercício

Other

Registry information

Official study title

A Sudden Rest-exercise Transition Training to Improve Cardiac Vagal Tone

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 7, 2013
Registry last updated
Nov 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.