Rest-exercise Transition Training to Improve Cardiac Vagal Tone

NCT01977742 | Completed

• 1 other identifier: 191.2011-15/12/11
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subjects Evaluated With Low Cardiac Vagal Tone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 year

Study Arms (2)

Initiate with SEP but without RTTE

ACTIVE COMPARATOR

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

Initiate with RETT and SEP

ACTIVE COMPARATOR

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

Interventions

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.

Initiate with RETT and SEP; Initiate with SEP but without RTTE

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.

Initiate with RETT and SEP; Initiate with SEP but without RTTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cardiac vagal index ≤ 1,30

You may not qualify if:

• pacemaker
• low adherence
• cognitive/physical impairment

Sponsors & Collaborators

• Clínica de Medicina do Exercício: lead

Study Officials

• Claudio Gil S Araujo, PhD

  Gama Filho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: October 1, 2013
• Last Updated: November 7, 2013

Record last verified: 2013-11