Rest-exercise Transition Training to Improve Cardiac Vagal Tone

NCT ID: NCT01977742

Last Updated: 2013-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-10-31

Brief Summary

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.

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.

Conditions

Subjects Evaluated With Low Cardiac Vagal Tone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Supervised exercise program

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Supervised exercise program

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• cardiac vagal index ≤ 1,30

Exclusion Criteria

• pacemaker
• low adherence
• cognitive/physical impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clínica de Medicina do Exercício

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Gil S Araujo, PhD

Role: PRINCIPAL_INVESTIGATOR

Gama Filho University

Other Identifiers

191.2011-15/12/11

Identifier Type: -

Identifier Source: org_study_id