NCT01816451

Brief Summary

The purpose of this study was to verify physiological responses to constant-load (continuous) vs. variable-intensity (interval) during 14 weeks of aerobic exercise on active men. The hypothesis was that would be differences in physiological variables on distinct modes of execution performed on the treadmill over a period of 14 weeks of training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 14, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

5 months

First QC Date

March 14, 2013

Results QC Date

June 15, 2013

Last Update Submit

April 10, 2014

Conditions

Keywords

aerobic capacitycardiorespiratory trainingblood lactate concentrationheart rate

Outcome Measures

Primary Outcomes (8)

  • Relative Maximal Oxygen Uptake

    The relative maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.

    Pre and post 14 weeks

  • Absolute Maximal Oxygen Uptake

    The absolute maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.

    Pre and post 14 weeks

  • Total Time Reaching on Maximal Test (tVO2max)

    The criterion for determining the total time reaching in maximal VO2 test was associated with the time immediately preceding heart rate shown a reduction of five or more beats.

    Pre and post 14 weeks/46 sessions of training

  • Heart Rate on Maximal Test

    The HR was collected pre and post training on maximal VO2 test. Initially, with the individual on the treadmill (Inbrasport Master Super, Porto Alegre, Brazil), electrodes (Micromed) were placed at the manubrium, right and left iliac crest for measured heart rate (HR) (derivation CM5) and were connected to an electromyography equipment (Micromed®). HR values were visualized through Elite software (Micromed Biotechnology, Brasilia, Brazil).

    Pre and post 14 weeks at rest (5 min sitting; before start the test), during the test (to determine max), and 60s and 120s immediately after the end of the test (on sitting position)

  • Blood Lactate Concentrations on Maximal Test

    Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the \[La\] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8-22 millimole (mM). The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument's instructions. The finger never touched the strip's pad in order to exclude any possible interference due to the sweat. All \[La\] were collected by a single, experienced investigator.

    Pre and post 14 weeks/46sessions on rest (5 min sitting position; before start the test); 1-3-5 min immediately after the end of the test (on sitting position).

  • Body Mass (BM)

    To measure body mass Filizola scales with a stadiometer was used.

    Body Mass was collected pre and post training

  • Rate of Perceived Exertion (RPE) on Maximal Test

    The RPE was collected at maximal test (see description of test on outcome measure "Maximal Oxygen Uptake"). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 - 10) scale. Instructions for RPE were that "0" corresponds to rest, and "9 - 10" corresponds to maximal exertion. This verbal procedure was explained before initiating exercise.

    Pre and post 14 weeks/46 sessions of training

  • Fat Mass (%)

    The subjects underwent a set of anthropometric assessments, which followed the norms of the International Society for Advancement of Kinanthropometry. The fat mass was calculated by percentage using the equation proposed by Jackson and Pollock (1978) from seven skinfold measurement. To measure the skinfolds, a Sanny Professional Skinfold Caliper was used.

    Pre and post 14 weeks/46 sessions of training

Secondary Outcomes (4)

  • Heart Rate on Submaximal Test

    Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training: rest (5-min sitting; before start the test); maximal during the test (maxHRsub); 60s-120s immediately after the end of the test (on sitting position).

  • Blood Lactate on Submaximal Test

    Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46 sessions training: rest (5-min sitting; before start the test); 1-3-5 minutes immediately after the end of the test (on sitting position).

  • Submaximal Velocity [Vsub]

    Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions of training

  • Rate of Perceived Exertion (RPE) on Submaximal Test

    Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training

Study Arms (3)

interval

EXPERIMENTAL

The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% of maximal heart rate (HRmax) (vigorous intensity), 88-93%HRmax (near maximum intensity) and 94-99% HRmax (maximum intensity).

Other: running training

continuous

EXPERIMENTAL

The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine.The continuous group ran at an intensity of \~87% of maximal heart rate (HRmax)

Other: running training

control

NO INTERVENTION

The control group did not do the running training program. Control did their normal physical activities.

Interventions

The present study was designed to compare the physiological effects between the two training regimes and the control group.The subjects from interval and continuous group performed others activities as resistance training, swimming or soccer. Those activities wasn't controlled by our study, but the individual didn't do physical activities at least 3 hours before started our running sessions. The control group simply performed their normal physical activities (resistance training, swimming or soccer). But, each 3 weeks we had a contact with control group to check about any injury or illness that could affect the final results. None were found.

Also known as: Stochastic, aerobic, run
continuousinterval

Eligibility Criteria

Age25 Years - 32 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • self reporting no contraindication to high-intensity exercise.
  • physically active on cardiorespiratory activities in a regular basis for at least six months.
  • presence of negative responses on all items of the Questionnaire of Physical Activity Readiness (PAR-Q Test).

You may not qualify if:

  • make use of medication that may interfere with the results, especially inhibitors appetites and dietary supplements.
  • presence of joint problems that prevents the achievement of training.
  • presence of disorders such as diabetes, dyslipidemia and anemia
  • have performed intense exercise with lowers members before the training sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEFAN

Rio de Janeiro, Rio de Janeiro, 21012350, Brazil

Location

MeSH Terms

Interventions

Stochastic ProcessesJogging

Intervention Hierarchy (Ancestors)

Statistics as TopicEpidemiologic MethodsInvestigative TechniquesMathematical ConceptsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthRunningLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Results Point of Contact

Title
Ph.D. Laura Castro de Garay
Organization
University of Trás-os-Montes and Alto Douro

Study Officials

  • Laura C Garay, Ph.D.

    University of Trás-os-Montes and Alto Douro

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 22, 2013

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

April 29, 2014

Results First Posted

January 14, 2014

Record last verified: 2014-04

Locations