Subjects Evaluated With Low Cardiac Vagal ToneNCT01977742
Rest-exercise Transition Training to Improve Cardiac Vagal Tone
A study testing Supervised exercise program and Supervised exercise program together with a specific sudden rest-exercise training protocol in people with Subjects Evaluated With Low Cardiac Vagal Tone, run by Clínica de Medicina do Exercício.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects Evaluated With Low Cardiac Vagal Tone
- What is being tested?
- Supervised exercise program and Supervised exercise program together with a specific sudden rest-exercise training protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cardiac vagal index ≤ 1,30
Who cannot join
- pacemaker
- low adherence
- cognitive/physical impairment
About this study
Official title: 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.
Read the 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.
- Being tested
- Supervised exercise program, Supervised exercise program together with a specific sudden rest-exercise training protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programOther
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Supervised exercise program; Other: Supervised exercise program together with a specific sudden rest-exercise training protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Evaluated With Low Cardiac Vagal ToneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica de Medicina do Exercício
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Gil S Araujo, PhD, Principal investigator, Gama Filho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977742
- Sponsor's protocol ID
- 191.2011-15/12/11
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sudden Rest-exercise Transition Training to Improve Cardiac Vagal Tone
- ClinicalTrials.gov ID
- NCT01977742
- Acronym / sponsor ID
- 191.2011-15/12/11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Clínica de Medicina do ExercícioUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initiate with SEP but without RTTE | Active comparator | Other: Supervised exercise program, Other: Supervised exercise program together with a specific sudden rest-exercise training protocolInitiate 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. |
| Initiate with RETT and SEP | Active comparator | Other: Supervised exercise program, Other: Supervised exercise program together with a specific sudden rest-exercise training protocolSupervised 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cardiac vagal index ≤ 1,30
Key exclusion criteria (3 listed)
- pacemaker
- low adherence
- cognitive/physical impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise programAerobic, 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 | Initiate with RETT and SEP, Initiate with SEP but without RTTE |
| Supervised exercise program together with a specific sudden rest-exercise training protocolAerobic, 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. | Other | Initiate with RETT and SEP, Initiate with SEP but without RTTE |
Primary outcome
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
1 secondary outcome
Longitudinal effects of supervised exercise program and rest-exercise transition training to improve cardiac vagal tone
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Gil S Araujo, PhD principal investigator
Gama Filho University
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise program and Supervised exercise program together with a specific sudden rest-exercise training protocol in people with Subjects Evaluated With Low Cardiac Vagal Tone, run by Clínica de Medicina do Exercício.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supervised exercise program and rest-exercise transition training to improve cardiac vagal tone (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.