Resistance TrainingNCT04569617
Autonomic Modulation Recovery After Acute Resistance Exercise
A study testing Resistance Training - UL endurance protocol, Resistance Training - UL strength protocol and Resistance Training - LL endurance protocol in people with Resistance Training, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites in Brazil.
Trial summary
To analyze the autonomic behavior in recovery post-acute resistance exercise performed in different intensities and body segments. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Resistance Training
- What is being tested?
- Resistance Training - UL endurance protocol, Resistance Training - UL strength protocol and Resistance Training - LL endurance protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Aug 2011to 20 Jan 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Graduate students,
- Age between 18 to 30 years
- Healthy men, the Physical Activity Readiness Questionnaire (PAR-Q) was used to determine safety and possible risk of exercising based on participants' health history, the according American College of Sports Medicine, 2010.
- Trained men, the International Physical Activity Questionnaire (IPAQ) was used to determine participants' physical activity level.
- Exclusion Criteria: Participants who did not attend all the RT protocols and those with HR record with error higher than 5% (ectopic beats) will be excluded.
- -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Luiz Carlos Marques Vanderlei
Presidente Prudente, São Paulo, 19060-900
Universidade Estadual Paulista Júlio de Mesquita Filho
Presidente Prudente, São Paulo, 19060900
About this study
Official title: Autonomic Modulation Recovery After Acute Resistance Exercise in Different Intensities and Body Segments
To analyze the autonomic behavior in recovery post-acute resistance exercise performed in different intensities and body segments.
Read the detailed description
Resistance training (RT) is recommended to people with different health condition. RT is recognized as safe and effective method of increasing muscle strength, physical fitness, muscle mass, and overall cardiovascular health. The magnitude of the RT effects is associated with the structure of the training program. Understanding these aspects may provide guidance for the RT prescription while reducing potential risk of cardiovascular events associated with the recovery period after exercise. The objective of the study is to compare the acute responses of the Autonomic Nervous System post RT performed with different intensities (endurance and strength) in different body segments (UL and LL). Our hypothesis is that different intensities and body segments influence the acute responses of the ANS in the post RT recovery period.
- Conditions
- Resistance Training
- Being tested
- Resistance Training - UL endurance protocol, Resistance Training - UL strength protocol, Resistance Training - LL endurance protocol, Resistance Training - LL strength protocol
- Keywords
- resistance training, autonomic modulation, heart rate, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training - UL endurance protocolOther
UL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
Resistance Training - UL strength protocolOther
UL strength protocol - 2 series of 8 repetitions, elbow flexion at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
Resistance Training - LL endurance protocolOther
LL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test strength of 1 maximum repetition, (recovery 1 minutes between sets).
Resistance Training - LL strength protocolOther
LL strength protocol - 2 series of 8 repetitions, knee extension at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
| Study group | Role | What they receive |
|---|---|---|
| upper limb endurance protocol | Active comparator | UL endurance protocol - elbow flexion Receives: Other: Resistance Training - UL endurance protocol |
| upper limb strength protocol | Active comparator | UL strength protocol - elbow flexion Receives: Other: Resistance Training - UL strength protocol |
| lower limb endurance protocol | Active comparator | LL endurance protocol - knee extension Receives: Other: Resistance Training - LL endurance protocol |
| lower limb strength protocol | Active comparator | LL strength protocol - knee extension Receives: Other: Resistance Training - LL strength protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute responses of the Autonomic Nervous System post Resistance Training of the time-domain indices of Heart Rate Variability
Understand the effect of acute responses of the time-domain indices of Heart Rate Variability, RMSSD, and SDNN, comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]).
RMSSD: root mean square of the successive differences between the RR intervals in the record, divided by the number of RR intervals in a given time minus one RR interval SDNN: standard deviation of all normal RR intervals.
Measured: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Acute responses of the Autonomic Nervous System post Resistance Training of the geometric indices of Heart Rate Variability
Understand the effect of acute responses of the geometric indices of Heart Rate Variability, SD1, SD2, comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]).
SD1: standard deviation of diagonal points SD2: standard deviation from longitudinal points
Measured: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Acute responses of the Autonomic Nervous System post Resistance Training of the frequency domain of Heart Rate Variability,
Understand the effect of acute responses of the frequency domain of Heart Rate Variability, LF anf HF, both calculated in absolute (ms2) and normalized units (nu), comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]).
LF: spectral components of low frequency, 0.04 - 0.15Hz HF: spectral components of high frequency, 0.15 - 0.40 Hz
Measured: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Aug 2011
- Primary completion30 Nov 2012
- Study completion20 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a cross-over clinical trial
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos M Vanderlei, Professor, Study director, Universidade Estadual Paulista - FCT/UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569617
- Sponsor's protocol ID
- 34303014.6.0000.5515
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Modulation Recovery After Acute Resistance Exercise in Different Intensities and Body Segments
- ClinicalTrials.gov ID
- NCT04569617
- Acronym / sponsor ID
- 34303014.6.0000.5515
- Conditions
- Resistance Training
- Keywords
- resistance training, autonomic modulation, heart rate, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 30 Nov 2012 (actual)
- Study completion
- 20 Jan 2015 (actual)
- First posted
- 30 Sep 2020 (actual)
- 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.
To analyze the autonomic behavior in recovery post-acute resistance exercise performed in different intensities and body segments.
Detailed description
Resistance training (RT) is recommended to people with different health condition. RT is recognized as safe and effective method of increasing muscle strength, physical fitness, muscle mass, and overall cardiovascular health. The magnitude of the RT effects is associated with the structure of the training program. Understanding these aspects may provide guidance for the RT prescription while reducing potential risk of cardiovascular events associated with the recovery period after exercise. The objective of the study is to compare the acute responses of the Autonomic Nervous System post RT performed with different intensities (endurance and strength) in different body segments (UL and LL). Our hypothesis is that different intensities and body segments influence the acute responses of the ANS in the post RT recovery period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is a cross-over clinical trial
| Arm | Type | Receives |
|---|---|---|
| upper limb endurance protocol | Active comparator | Other: Resistance Training - UL endurance protocolUL endurance protocol - elbow flexion |
| upper limb strength protocol | Active comparator | Other: Resistance Training - UL strength protocolUL strength protocol - elbow flexion |
| lower limb endurance protocol | Active comparator | Other: Resistance Training - LL endurance protocolLL endurance protocol - knee extension |
| lower limb strength protocol | Active comparator | Other: Resistance Training - LL strength protocolLL strength protocol - knee extension |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Graduate students,
- Age between 18 to 30 years
- Healthy men, the Physical Activity Readiness Questionnaire (PAR-Q) was used to determine safety and possible risk of exercising based on participants' health history, the according American College of Sports Medicine, 2010.
- Trained men, the International Physical Activity Questionnaire (IPAQ) was used to determine participants' physical activity level.
- Exclusion Criteria: Participants who did not attend all the RT protocols and those with HR record with error higher than 5% (ectopic beats) will be excluded.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Resistance Training - UL endurance protocolUL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets). | Other | upper limb endurance protocol |
| Resistance Training - UL strength protocolUL strength protocol - 2 series of 8 repetitions, elbow flexion at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets). | Other | upper limb strength protocol |
| Resistance Training - LL endurance protocolLL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test strength of 1 maximum repetition, (recovery 1 minutes between sets). | Other | lower limb endurance protocol |
| Resistance Training - LL strength protocolLL strength protocol - 2 series of 8 repetitions, knee extension at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets). | Other | lower limb strength protocol |
Primary outcome
Acute responses of the Autonomic Nervous System post Resistance Training of the time-domain indices of Heart Rate Variability
Time frame: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Understand the effect of acute responses of the time-domain indices of Heart Rate Variability, RMSSD, and SDNN, comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]). RMSSD: root mean square of the successive differences between the RR intervals in the record, divided by the number of RR intervals in a given time minus one RR interval SDNN: standard deviation of all normal RR intervals.
Acute responses of the Autonomic Nervous System post Resistance Training of the geometric indices of Heart Rate Variability
Time frame: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Understand the effect of acute responses of the geometric indices of Heart Rate Variability, SD1, SD2, comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]). SD1: standard deviation of diagonal points SD2: standard deviation from longitudinal points
Acute responses of the Autonomic Nervous System post Resistance Training of the frequency domain of Heart Rate Variability,
Time frame: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Understand the effect of acute responses of the frequency domain of Heart Rate Variability, LF anf HF, both calculated in absolute (ms2) and normalized units (nu), comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]). LF: spectral components of low frequency, 0.04 - 0.15Hz HF: spectral components of high frequency, 0.15 - 0.40 Hz
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 30 Sep 2020.
- Catai, A. M., Pastre, C. M., Godoy, M. F. de, Silva, E. da, Takahashi, A. C. de M., \& Vanderlei, L. C. M. (2019). Heart rate variability: are you using it properly? Standardisation checklist of procedures. Brazilian Journal of Physical TherapyLink provided by the sponsor.
- Collins H., Booth J.N., Duncan A., Fawkner S., Niven A. The effect of resistance training interventions on 'The Self' in Youth: a systematic review and meta-analysis.Link provided by the sponsor.
- Evans JW. Periodized resistance training for enhancing skeletal muscle hypertrophy and strength: a mini review.Link provided by the sponsor.
- Kingsley, J. D., \& Figueroa, A. (2016). Acute and training effects of resistance exercise on heart rate variability.Link provided by the sponsor.
- Guedes DP, Lopes CC, Guedes JERP. (2005). Reprodutibilidade e validade do Questionário Internacional de Atividade Física em adolescentes.Link provided by the sponsor.
- Vanderlei, Luiz Carlos Marques, Pastre, C. M., Hoshi, A., Dias, T., \& Fernandes, M. (2009). Noções básicas de variabilidade da frequência cardíaca e sua aplicabilidade clínica.Link provided by the sponsor.
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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.
Luiz Carlos M Vanderlei, Professor study director
Universidade Estadual Paulista - FCT/UNESP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training - UL endurance protocol, Resistance Training - UL strength protocol and Resistance Training - LL endurance protocol in people with Resistance Training, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites 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 6 inclusion and 0 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 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Acute responses of the Autonomic Nervous System post Resistance Training of the time-domain indices of Heart Rate Variability (time frame: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).). The study lists 3 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 30 Sep 2020.