Rest-exercise Transition Training to Improve Cardiac Vagal Tone

A Sudden 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.

Study Overview

• Status: Completed
• Conditions: Subjects Evaluated With Low Cardiac Vagal Tone
• Intervention / Treatment: Other: Supervised exercise program; Other: Supervised exercise program together with a specific sudden rest-exercise training protocol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• cardiac vagal index ≤ 1,30

Exclusion Criteria:

• pacemaker
• low adherence
• cognitive/physical impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Initiate with SEP but without RTTE; Initiate supervised exercise (SEP) program but without rest-exercise transition training (RTTE)to improve cardiac vagal tone at same time; will stop RTTE after 8 weeks.	Other: Supervised exercise program; 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.; Other: Supervised exercise program together with a specific sudden rest-exercise training protocol; 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.
Active Comparator: Initiate with RETT and SEP; Supervised exercise program (aerobic, strength and flexibility exercises) and a specific sudden rest-exercise training protocol, three times a week. After 8 weeks, the sudden rest-exercise training protocol will be discontinued. The cardiac vagal index will be measured at every 8 weeks.	Other: Supervised exercise program; 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.; Other: Supervised exercise program together with a specific sudden rest-exercise training protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supervised exercise program and rest-exercise transition training to improve cardiac vagal tone	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	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal effects of supervised exercise program and rest-exercise transition training to improve cardiac vagal tone	Cardiac vagal tone measures at every 8 weeks after both phases (16 weeks of training / no training, depending of the randomization) during a year	1 year

Collaborators and Investigators

• Sponsor: Clínica de Medicina do Exercício
• Investigators: Principal Investigator: Claudio Gil S Araujo, PhD, Gama Filho University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 191.2011-15/12/11