Physical ActivityNCT03425981
Effects of WB-EMS in Runners.
A study testing Whole-Body Electromyostimulation Training in people with Physical Activity, run by Universidad de Granada at 1 site in Spain.
Trial summary
The subjects will be randomly distributed into 3 experimental groups: training with basic global electrostimulation (WB-EMS-SRT), training with specific global electrostimulation for runners (WB-EMS-WT) and control group (CG). Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Whole-Body Electromyostimulation Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 15 Jan 2018
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Frequent runners
Who cannot join
- Received WB-EMS training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF WHOLE-BODY ELECTROMYOSTIMULATION TRAINING ON HEALTH AND PERFORMANCE PARAMETERS IN RECREATIONAL RUNNERS.
The subjects will be randomly distributed into 3 experimental groups: training with basic global electrostimulation (WB-EMS-SRT), training with specific global electrostimulation for runners (WB-EMS-WT) and control group (CG).
Initially and at the end of the intervention period, which will consist of six weeks, the subjects will undergo a series of tests: (1) Maximum incremental effort test in tapestry to exhaustion to determine cardiorespiratory capacity (VO2max) and thresholds (aerobic and anaerobic). (2) Submaximal carpet test at constant speed to determine race economy (EC). (3) Lower train power test (CMJ and Abalakov). (4) Weight, size and waist circumference. The aforementioned tests will be carried out on different days to avoid the effect of fatigue on performance with a break of more than 48 hours between tests.
The participants in the control group will maintain the volume and intensity of the training prior to the intervention study and the subjects of the WB-EMS and WB-EMS-AC groups will substitute one conventional training day for one with global electrostimulation for six weeks; the training of the first group will be non-specific and that of the second specific for runners and the duration of both will be 20 minutes.
Read the detailed description
A randomized controlled trial design was applied following CONSORT statements. After baseline measurements, participants were randomized into two groups: (i) WB-EMS group and (ii) Control Group (CG). Participants in the WB-EMS group were instructed to reduce their running training program volume, whereas the CG continued with their running training in term of volume and intensity: two or three times per week (45-60 minutes per day) at an intensity of 60-70% hearth rate reserve, which was controlled by heart rate monitor (Polar RS300X, POLAR, Kempele, Finland), and with 24-48 hours of rest between sessions
- Conditions
- Physical Activity
- Being tested
- Whole-Body Electromyostimulation Training
- Keywords
- WB-EMS, Running economy, VO2max
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body Electromyostimulation TrainingOther
The WB-EMS training program consisted of six WB-EMS training sessions (one per week) and six running training sessions (also one per week).
This intervention programme followed a within-day undulating periodization model. The training sessions were divided into four parts: warm up (A), strength (B), high intensity interval power training (c), and high intensity interval training (HIIT) (D).
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS-SRT | Experimental | Training with basic global electrostimulation Receives: Other: Whole-Body Electromyostimulation Training |
| WB-EMS-WT | Experimental | Training with specific global electrostimulation for runners Receives: Other: Whole-Body Electromyostimulation Training |
| CG | Placebo comparator | The participants in the control group will maintain the volume and intensity of the training prior to the intervention study and the subjects of the WB-EMS and WB-EMS-AC groups will substitute one conventional training day for one with global electrostimulation for six weeks; the training of the first group will be non-specific and that of the second specific for runners and the duration of both will be 20 minutes. Receives: Other: Whole-Body Electromyostimulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption
Maximal Oxygen consumption was assessed using a maximum treadmill (H/P/ Cosmos Pulsar treadmill, H/P/Cosmos Sport \& Medical GMBH, Germany) exercise test with a progressive incremental protocol that has been used.
Measured: Baseline and through study completion, an average of 5 weeks
Secondary outcomes (5)
Ventilatory thresholds
VT1 and VT2 were estimated from gas exchange data through different respiratory variables: minute ventilation (VE) and equivalents for oxygen (VE/VO2) and carbon dioxide (VE/VCO2) by two independent researchers
Measured: Baseline and through study completion, an average of 5 weeks
Running economy
RE was determined during a treadmill test following a specific protocol used in previous studies
Measured: Baseline and through study completion, an average of 5 weeks
Muscular power
Vertical jump performance was assessed using the Bosco Test.
Measured: Baseline and through study completion, an average of 5 weeks
Weight
Weight in Kilograms
Measured: Baseline and through study completion, an average of 5 weeks
Body composition
Assessed using DXA.
Measured: Baseline and through study completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Dec 2017
- Primary completion15 Dec 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Castillo Garzón, Universidad de Granada
- Investigators
- Baseline and post Castillo Garzón, University Proffesor, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425981
- Sponsor's protocol ID
- 200/CEIH/2016
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF WHOLE-BODY ELECTROMYOSTIMULATION TRAINING ON HEALTH AND PERFORMANCE PARAMETERS IN RECREATIONAL RUNNERS.
- ClinicalTrials.gov ID
- NCT03425981
- Acronym / sponsor ID
- 200/CEIH/2016
- Conditions
- Physical Activity
- Keywords
- WB-EMS, Running economy, VO2max
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 8 Feb 2018 (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.
The subjects will be randomly distributed into 3 experimental groups: training with basic global electrostimulation (WB-EMS-SRT), training with specific global electrostimulation for runners (WB-EMS-WT) and control group (CG).
Initially and at the end of the intervention period, which will consist of six weeks, the subjects will undergo a series of tests: (1) Maximum incremental effort test in tapestry to exhaustion to determine cardiorespiratory capacity (VO2max) and thresholds (aerobic and anaerobic). (2) Submaximal carpet test at constant speed to determine race economy (EC). (3) Lower train power test (CMJ and Abalakov). (4) Weight, size and waist circumference. The aforementioned tests will be carried out on different days to avoid the effect of fatigue on performance with a break of more than 48 hours between tests.
The participants in the control group will maintain the volume and intensity of the training prior to the intervention study and the subjects of the WB-EMS and WB-EMS-AC groups will substitute one conventional training day for one with global electrostimulation for six weeks; the training of the first group will be non-specific and that of the second specific for runners and the duration of both will be 20 minutes.
Detailed description
A randomized controlled trial design was applied following CONSORT statements. After baseline measurements, participants were randomized into two groups: (i) WB-EMS group and (ii) Control Group (CG). Participants in the WB-EMS group were instructed to reduce their running training program volume, whereas the CG continued with their running training in term of volume and intensity: two or three times per week (45-60 minutes per day) at an intensity of 60-70% hearth rate reserve, which was controlled by heart rate monitor (Polar RS300X, POLAR, Kempele, Finland), and with 24-48 hours of rest between sessions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WB-EMS-SRT | Experimental | Other: Whole-Body Electromyostimulation TrainingTraining with basic global electrostimulation |
| WB-EMS-WT | Experimental | Other: Whole-Body Electromyostimulation TrainingTraining with specific global electrostimulation for runners |
| CG | Placebo comparator | Other: Whole-Body Electromyostimulation TrainingThe participants in the control group will maintain the volume and intensity of the training prior to the intervention study and the subjects of the WB-EMS and WB-EMS-AC groups will substitute one conventional training day for one with global electrostimulation for six weeks; the training of the first group will be non-specific and that of the second specific for runners and the duration of both will be 20 minutes. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Frequent runners
Key exclusion criteria (1 listed)
- Received WB-EMS training.
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 |
|---|---|---|
| Whole-Body Electromyostimulation TrainingThe WB-EMS training program consisted of six WB-EMS training sessions (one per week) and six running training sessions (also one per week). This intervention programme followed a within-day undulating periodization model. The training sessions were divided into four parts: warm up (A), strength (B), high intensity interval power training (c), and high intensity interval training (HIIT) (D). | Other | CG, WB-EMS-SRT, WB-EMS-WT |
Primary outcome
Maximal oxygen consumption
Time frame: Baseline and through study completion, an average of 5 weeks
Maximal Oxygen consumption was assessed using a maximum treadmill (H/P/ Cosmos Pulsar treadmill, H/P/Cosmos Sport \& Medical GMBH, Germany) exercise test with a progressive incremental protocol that has been used.
5 secondary outcomes
Ventilatory thresholds
Time frame: Baseline and through study completion, an average of 5 weeks
Running economy
Time frame: Baseline and through study completion, an average of 5 weeks
Muscular power
Time frame: Baseline and through study completion, an average of 5 weeks
Weight
Time frame: Baseline and through study completion, an average of 5 weeks
Body composition
Time frame: Baseline and through study completion, an average of 5 weeks
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 8 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Baseline and post Castillo Garzón, University Proffesor study director
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Electromyostimulation Training in people with Physical Activity, run by Universidad de Granada at 1 site in Spain.
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 1 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 8 Feb 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Maximal oxygen consumption (time frame: Baseline and through study completion, an average of 5 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 8 Feb 2018.