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Health BehaviorTRAINING2014NCT02441192

Different Training (Aerobic, Resistance or Mixed) Physical Programs Affect to Physiological Responses (TRAINING2014)

A study testing Training resistance, Training aerobic and Training resistance+aerobic in people with Health Behavior, run by University of Barcelona.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background. The cardiovascular and cardiorespiratory coupling (CVCRC), focusing to recognize the synergies of standard or modified physiology that promote healthy. The investigators aim to study the effects of different training modalities and detraining on CVCRC. Methods. Read more about this study

Who is it for?
Ages 18 to 26 years, men onlyHealthy volunteers can take part
Conditions the study is for
Health Behavior
What is being tested?
Training resistance, Training aerobic and Training resistance+aerobic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2013to May 2015
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 to 26 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy physically active males
  • physical education students
  • signed an informed consent form

Who cannot join

  • No confirm their healthy status
  • No signed an informed consent form

About this study

Official title: Cardiovascular and Cardiorespiratory Coupling After Different Types of Training and Detraining

Background. The cardiovascular and cardiorespiratory coupling (CVCRC), focusing to recognize the synergies of standard or modified physiology that promote healthy. The investigators aim to study the effects of different training modalities and detraining on CVCRC.

Methods. 32 young males were distributed in four randomized training groups: aerobic (AT), resistance (RT), aerobic plus resistance (AT+RT) and control (C). They were tested before, after the training (6 weeks) and after the detraining (3 weeks) through a graded maximal test. A principal component (PC) analysis of the time series of selected cardiovascular and cardiorespiratory variables was performed to evaluate the CVCRC. The PC1 coefficient of congruence in the 3 experimental conditions (before, after training and after detraining) was calculated for each group.

Read the detailed description

The study of the cardiovascular and cardiorespiratory coupling (CVRC) is a hot topic in the medical literature focused to recognize the synergies that are present in healthy physiology [7, 8]. Several effects as aging [9], diseases [8] or mental state interventions [10] on cardiorespiratory coupling have been investigated, however, although its potential interest, there are no studies on the effects of training programs and detraining.

Two main types of training programs (aerobic- AT and resistance- RT) have been widely investigated by their important and different physiological effects [11]. Its combination (AT+RT), has been recently recommended with health purposes for extensive types of population [12-14].

The physiological effects of aerobic training programs has been traditionally evaluated through the cardiorespiratory reserve and the detection of maximal or threshold subsystem variables [1]. As a complex adaptive system (CAS), the human organism acts as an indivisible and integrated whole that cannot be reduced to the sum of its subsystems functions [2]. In this CAS the cardiovascular and cardiorespiratory subsystems are interdependent and interact in a dynamic and nonlinear way, i.e. non-proportional, which needs to be approached through nonlinear models [3], the study of time series and complex systems (CS) methodologies [4]. As the CAS enter every new situation with an existing set of capabilities [5] and exchange continuously information with their environment her/his behavior is unique and unexpected at short term (weeks, months) [6], the usual duration of common training programs.

In order to study the couplings and coordination between multiple variables in CAS, CS approaches propose the detection of the so-called order parameters, collective or coordinative variables, because they capture the order or coordination of the system [3, 15]. The principal component (PC) analysis is a common statistical technique that has been used to recognize such coordinative variables in a vast domain of biological research fields like: motor control [16], brain dynamics [17], DNA replication [18] or protein folding [19]. The PC analysis reduces the data dimension of highly coupled systems extracting the smallest number of components that account for most of the variation in the original multivariate data and summarize it with little loss of information. PCs are extracted in decreasing order of importance so that the first PC accounts for as much of the variation as possible and each successive component accounts for a little less [20]. The number of PCs reflects the dimensionality of the system, being a decrease of the number of PCs indicative of a major coupling (less dimensions) and vice-versa. The number of PCs changes when the system suffers a nonlinear change, i.e. a qualitative or coordinative reconfiguration. The PCs technique applied to kinematic variables has been successfully used to study the effects of motor learning processes [16], but has not been applied yet to study training effects on physiological variables.

The aim of this research was to investigate the dimensional changes of the CVCRC before and after a period of 6 weeks of different training modalities (AT, RT and AT+RT) and 3 weeks after detraining in healthy young men.

Material and Methods Participants. To determine the sample size a power analysis was performed. Using an effect size of d = .80, alfa < .05, power (1 - beta) = .95, with three repeated windows, we estimated a sample size = 32 [21]. Thirty-two healthy physically active males, physical education students (age 21.2 ± 2.4 y., height of 177.1 ± 0.66 cm, mean body mass 71.0 ± 5.1 kg and mean body -mass index 22.6 ± 1.7 kg·m-2) with no sport specialization but engaged in a wide range of aerobic activities at least three times a week volunteered to participate in this study. After the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).

Procedure. Participants completed a standard medical questionnaire to confirm their healthy status and signed an informed consent form. All experimental procedures were approved by the local bio-ethics committee and were carried out in accordance with the ethical guidelines laid down in the Helsinki Declaration. After the baseline cardiorespiratory testing and maximal strength and power tests (see below) they followed 3 times a week their assigned specific training program:

  1. AT group (n = 8): they pedalled 60 min at 60% of their individual maximum workload (60% Wmax). This workload was increased by 5% weekly unless the participant was unable to keep the pace throughout the session. Heart rate was monitored during all the sessions.
  2. RT group (n = 8): they performed twice a 30 min strength circuit[14]. Forty per cent of 1RM for the upper body (i.e., squat, chest press, shoulder press, triceps extension, biceps curl, pull-down [upper back]), and 60% for the lower body (quadriceps extension, leg press, leg curls [hamstrings], and calf raise) were used as starting weights. They allowed the participants a maximum of 12 repetitions which included a slow controlled movement (2s up and 4s down). The resting period between exercises was 2 min. Workloads were adjusted weekly, with resistance being increased as needed (typically 5 up to 10%) if the participant was able to lift the weight comfortably (i.e., more than 12 repetitions).
  3. AT+RT group (n = 8): they pedalled at 60% Wmax during 30 min and performed once the strength circuit (as R group).
  4. C group (n = 8): continued with their usual activities, without any special training.

Cardiorespiratory testing. The incremental cycling test (Excalibur, Lode, Groningen, Netherlands) started at 0W and the workload increased 20W/min until exhaustion participants could not keep the prescribed cycling frequency of 70rpm during more than 5 consecutive seconds. All tests were performed in a well-ventilated lab; the room temperature was 23ºC and the relative humidity 48%, with variations of no more than 1ºC in temperature and 10% in relative humidity. During the test the subjects breathed through a valve (Hans Rudolph 2700, Kansas City, MO, USA) and respiratory gas exchange was determined using an automated open-circuit system (Metasys, Brainware, La Valette, France). Oxygen and CO2 content and air flow rate were recorded breath by breath. Before each trial, the system was calibrated with a mixture of O2 and CO2 of known composition (O2 15%, CO2 5%, N2 balanced) (Carburos Metálicos, Barcelona, Spain) and with ambient air. Hemodynamic information of participants was determined with non-invasive finger cuff technology (Nexfin, BMEYE Amsterdam, Netherlands). The Nexfin device provides continuous blood pressure (BP) monitoring from the resulting pulse pressure waveform, and calculates: systolic and diastolic blood pressure (SBP and DBP). Participants were connected by wrapping an inflatable cuff around the middle phalanx of the finger. The finger artery pulsing is 'fixed' to a constant volume by application of an equivalent change in pressure against the blood pressure resulting in a waveform of the pressure (clamp volume method). Electrocardiogram (ECG) was continuously monitored (DMS Systems, DMS-BTT wireless Bluetooth ECG transmitter and receiver, software DMS Version 4.0, Beijing, China). The tests were carried out at least 3 hours after a light meal and participants were instructed not to perform any vigorous physical activity for 72 hours before testing. Participants repeated this test after 6 weeks of training and after 3 weeks of detraining.

Maximal strength and power testing. Maximal strength and maximal power of upper and lower limbs, respectively, were measured (Musclelab Power System, Porsgruun, Norway) in each participant. Estimated 1 RM-chest press and 1RM-squat based on submaximal loads was calculated. In the chest press exercise the load started with 25 kg, and continued with 35 kg, 45 kg, 55 kg, 65 kg, etc. and in the squat exercise they started with 45 kg and continued with 65 kg, 85 kg, 105 kg, etc. until they could not perform 1 repetition. Based on these results the maximal 1RM was registered and the force/velocity relationship graph was plotted to determine the maximal power.

All exercise tests were carried out at least 3 hours after a light meal and participants were instructed not to perform any vigorous physical activity for 72 hours before testing. Participants repeated these tests after 6 weeks of training and after 3 weeks of detraining.

Data analysis The following maximal values of performance and cardiorespiratory variables were registered during the tests: maximal cycling workload (Wmax), maximal oxygen uptake (VO2 max), maximal expiratory ventilation per minute (VE max), maximal heart rate (HR max), maximal 1RM-squat and maximal 1RM-chest. The group means in the different conditions were compared using the non-parametric Friedman.

A PC analysis of the time series of the following selected cardiorespiratory variables: expired fraction of O2 (FeO2), expired fraction of CO2 (FeCO2), ventilation (VE), systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) was performed to obtain information about the CVCRC in each participant. The median of PC1 coefficient of congruence was obtained in each group and condition (before, after training and detraining). The null hypothesis of a constant PC congruence median over the control group and the training groups was tested through non-parametric Kruskal-Wallis. Mann Whitney U matched pairs test analysis was also performed to assess statistically significant differences between each couple of different conditions. Effect sizes (Cohen's d) were computed to demonstrate the magnitude of standardized medians' differences where effects reached p < .05 level.

Conditions
Health Behavior
Being tested
Training resistance, Training aerobic, Training resistance+aerobic
Keywords
physical training, aerobic training, resistance training
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training resistanceOther

    After the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).

  • Training aerobicOther

    After the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).

  • Training resistance+aerobicOther

    After the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).

Study groups in NCT02441192
Study groupRoleWhat they receive
Training resistanceExperimentalAfter the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).
Receives: Other: Training resistance
Training aerobicExperimentalAfter the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).
Receives: Other: Training aerobic
Training resistance+aerobicExperimentalAfter the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).
Receives: Other: Training resistance+aerobic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular and cardiorespiratory coupling by the principal component (PC) analysis

    A PC analysis of the time series of the following selected cardiorespiratory variables: expired fraction of O2 (FeO2), expired fraction of CO2 (FeCO2), ventilation (VE), systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) is performed to obtain information about the CVCRC in each participant.

    (The principal component (PC) analysis is a common statistical technique that has been used to recognize such coordinative variables)

    The median of PC1 coefficient of congruence was obtained in each group and condition (before, after training and detraining) to evaluate the dimensional changes of the CVCRC before and after a period of 6 weeks of different training modalities (AT, RT and AT+RT) and 3 weeks after detraining in healthy young men.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2013
  4. Study completionMay 2015

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441192
Sponsor's protocol ID
U.Barcelona
Acronym
TRAINING2014
Status last verified
Jun 2015
First submitted
28 Apr 2015
Last updated
11 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Friedman L, Dick TE, Jacono FJ, Loparo KA, Yeganeh A, Fishman M, Wilson CG, Strohl KP. Cardio-ventilatory coupling in young healthy resting subjects. J Appl Physiol (1985). 2012 Apr;112(8):1248-57. doi: 10.1152/japplphysiol.01424.2010. Epub 2012 Jan 19.

    PubMed 22267392
  • Garcia AJ 3rd, Koschnitzky JE, Dashevskiy T, Ramirez JM. Cardiorespiratory coupling in health and disease. Auton Neurosci. 2013 Apr;175(1-2):26-37. doi: 10.1016/j.autneu.2013.02.006. Epub 2013 Mar 13.

    PubMed 23497744
  • Wu SD, Lo PC. Cardiorespiratory phase synchronization during normal rest and inward-attention meditation. Int J Cardiol. 2010 Jun 11;141(3):325-8. doi: 10.1016/j.ijcard.2008.11.137. Epub 2009 Jan 14.

    PubMed 19144415
  • Braith RW, Stewart KJ. Resistance exercise training: its role in the prevention of cardiovascular disease. Circulation. 2006 Jun 6;113(22):2642-50. doi: 10.1161/CIRCULATIONAHA.105.584060. No abstract available.

    PubMed 16754812
  • Pollock ML, Franklin BA, Balady GJ, Chaitman BL, Fleg JL, Fletcher B, Limacher M, Pina IL, Stein RA, Williams M, Bazzarre T. AHA Science Advisory. Resistance exercise in individuals with and without cardiovascular disease: benefits, rationale, safety, and prescription: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association; Position paper endorsed by the American College of Sports Medicine. Circulation. 2000 Feb 22;101(7):828-33. doi: 10.1161/01.cir.101.7.828. No abstract available.

    PubMed 10683360

Questions about this trial

What is this clinical trial studying?

A study testing Training resistance, Training aerobic and Training resistance+aerobic in people with Health Behavior, run by University of Barcelona.

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 3 inclusion and 2 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 11 Jun 2015. 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?

Cardiovascular and cardiorespiratory coupling by the principal component (PC) analysis (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441192, which also lists 5 linked publications.

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 11 Jun 2015.

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