Exhaustion - PhysiologicalNCT01816451
Physiologic Adaptations to Interval and Continuous Running at Low Volume and Vigorous Intensity Over 14-Weeks.
A study testing running training in people with Exhaustion - Physiological, run by University of Trás-os-Montes and Alto Douro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 32 years, men only
- Conditions the study is for
- Exhaustion - Physiological
- What is being tested?
- running training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 32 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Responses to Constant-load (Continuous) vs. Variable-intensity (Interval) During 14 Weeks of Supervised Aerobic Exercise on Active Men.
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.
Read the detailed description
Initially there were thirty five subjects, but due factors outside the present study, three individuals were excluded from the program. Two individuals during maximal exercise test (VO2) showed clinical impairment test being interrupted by the doctor and the third individual presented a plantar fasciitis in the early familiarization. Thirty two healthy and active males volunteered to participate in the study. All subjects exercised habitually, with at least 1 year experience aerobic training. The Human Ethics Committee of Rio de Janeiro Federal University approved this study (no 58659/02471312.8.0000.5257).The subjects performed a total of nine visits to the laboratory of the Brazilian Navy at City of Rio de Janeiro for physical tests on different days, except between visits I-II and VII-III. The interval between visits was one week between visits II-III-IV and VIII-IX, six weeks between the first day of training and visits V, four weeks between V-VI-VIII. All subjects from interval and continuous groups performed a total of 46 sessions of supervised running program.
- Conditions
- Exhaustion - Physiological
- Being tested
- running training
- Keywords
- aerobic capacity, cardiorespiratory training, blood lactate concentration, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
running trainingOther
Also called Stochastic, aerobic, run
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Other: running training |
| control | No intervention | The control group did not do the running training program. Control did their normal physical activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre and post 14 weeks/46 sessions of training
Secondary outcomes (4)
Heart Rate on Submaximal Test
Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes.The test velocity should be clearly constant at the end of the test. Heart rate were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the HR values for training intensities.
Measured: 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
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 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 we never let the finger touch the strip's pad in order to exclude any possible interference due to the sweat.
Measured: 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]
Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes. The test velocity should be clearly constant at the end of the test. Values of velocity were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the value of that speed has stabilized.
Measured: 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
The RPE was collected at submaximal test (see description of test on outcome measure "HR at submaximal test"). 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.
Measured: Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exhaustion - PhysiologicalStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Castro de Garay, University of Trás-os-Montes and Alto Douro
- Investigators
- Laura C Garay, Ph.D., Principal investigator, University of Trás-os-Montes and Alto Douro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816451
- Sponsor's protocol ID
- UFRJ-2010
- Status last verified
- Apr 2014
- First submitted
- 14 Mar 2013
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses to Constant-load (Continuous) vs. Variable-intensity (Interval) During 14 Weeks of Supervised Aerobic Exercise on Active Men.
- ClinicalTrials.gov ID
- NCT01816451
- Acronym / sponsor ID
- UFRJ-2010
- Conditions
- Exhaustion - Physiological
- Keywords
- aerobic capacity, cardiorespiratory training, blood lactate concentration, heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Posted 14 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Initially there were thirty five subjects, but due factors outside the present study, three individuals were excluded from the program. Two individuals during maximal exercise test (VO2) showed clinical impairment test being interrupted by the doctor and the third individual presented a plantar fasciitis in the early familiarization. Thirty two healthy and active males volunteered to participate in the study. All subjects exercised habitually, with at least 1 year experience aerobic training. The Human Ethics Committee of Rio de Janeiro Federal University approved this study (no 58659/02471312.8.0000.5257).The subjects performed a total of nine visits to the laboratory of the Brazilian Navy at City of Rio de Janeiro for physical tests on different days, except between visits I-II and VII-III. The interval between visits was one week between visits II-III-IV and VIII-IX, six weeks between the first day of training and visits V, four weeks between V-VI-VIII. All subjects from interval and continuous groups performed a total of 46 sessions of supervised running program.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| interval | Experimental | Other: running trainingThe 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). |
| continuous | Experimental | Other: running trainingThe 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) |
| control | No intervention | –The control group did not do the running training program. Control did their normal physical activities. |
Who may qualify
- Ages
- 25 to 32 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| running trainingAlso: Stochastic, aerobic, runThe 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. | Other | continuous, interval |
Primary outcome
Relative Maximal Oxygen Uptake
Time frame: Pre and post 14 weeks
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.
Absolute Maximal Oxygen Uptake
Time frame: Pre and post 14 weeks
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.
Total Time Reaching on Maximal Test (tVO2max)
Time frame: Pre and post 14 weeks/46 sessions of training
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.
Heart Rate on Maximal Test
Time frame: 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)
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).
Blood Lactate Concentrations on Maximal Test
Time frame: 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).
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.
Body Mass (BM)
Time frame: Body Mass was collected pre and post training
To measure body mass Filizola scales with a stadiometer was used.
Rate of Perceived Exertion (RPE) on Maximal Test
Time frame: Pre and post 14 weeks/46 sessions of training
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.
Fat Mass (%)
Time frame: Pre and post 14 weeks/46 sessions of training
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.
4 secondary outcomes
Heart Rate on Submaximal Test
Time frame: 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
Time frame: 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]
Time frame: 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
Time frame: Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Laura C Garay, Ph.D. principal investigator
University of Trás-os-Montes and Alto Douro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing running training in people with Exhaustion - Physiological, run by University of Trás-os-Montes and Alto Douro at 1 site in Brazil.
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 4 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relative Maximal Oxygen Uptake (time frame: Pre and post 14 weeks). The study lists 8 primary outcomes in all. 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 29 Apr 2014; AzTrials last refreshed its copy on 27 Oct 2026.