Sports Physical TherapyNCT05218512
WB-EMS Increase Energy Expenditure at Rest and During Uphill Walking Exercise
An observational study of Sports Physical Therapy, run by Universidad de Granada at 1 site in Spain.
Trial summary
Whole-body electrical stimulation (WB-EMS) has become increasingly popular as a tool to provide additional benefits compared to conventional exercise. However, the effects of the different electrical parameters on energy expenditure (EE) and respiratory exchange ratio (RER) remain poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- WB-EMS
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 30 Nov 2018
- Phase
- Observational
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: We chose recreationally active males without any disease.
Who may be able to join
- (i) no previous experience with WB-EMS training
- (ii) having a stable body weight (variation of <5 kg in body weight over the previous 3 months)
- (iii) normal weight (body mass index (BMI) between 18.5-25.0 kg/m2)
Who cannot join
- (i) Suffering from any health problem that might be aggravated by exercise or any contraindications for WB-EMS, such as total endoprosthesis, epilepsy and abdomen/groin hernia
- (ii) Taking medications
- (iii) Chronic metabolic disease or cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Whole-body Electromyostimulation on Energy Expenditure at Resting and During Uphill Walking in Healthy Young Men
Whole-body electrical stimulation (WB-EMS) has become increasingly popular as a tool to provide additional benefits compared to conventional exercise. However, the effects of the different electrical parameters on energy expenditure (EE) and respiratory exchange ratio (RER) remain poorly understood. This study aims to determine and compare the effects of different electrical frequencies applied with WB-EMS in EE and RER at supine resting and during uphill walking exercise
Read the detailed description
Obesity is a critical public health problem worldwide since it is a risk factor for cardiovascular diseases and mortality. Increased body weight and obesity are the results of an imbalance between energy intake and energy expenditure (EE). Body weight regulation and obesity are highly influenced by different factors such as genetic, physiology, and socioeconomics. It is well known that physical exercise is an effective strategy to increase EE, improve body composition, physical fitness, and cardiometabolic risk factors. Unfortunately, the principal barriers to abstaining from exercise are time constraints, the risk of injuries, and the lack of enthusiasm observed during the exercise sessions. In this context, whole-body electromyostimulation (WB-EMS) training is becoming increasingly popular worldwide as a potential and attractive alternative to traditional training methods to increase EE. The present study aimed to determine and compare the effects of different electrical frequencies applied with WB-EMS in EE and RER at supine resting and during uphill walking exercise.
- Conditions
- Sports Physical Therapy
- Being tested
- WB-EMS
- Keywords
- Electrical stimulation, Energy expenditure, Obesity, Impulse intensities, Impulse frequencies
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-EMSOther
The group has been submitted to 2 experimental conditions:
- At rest with superimposed WB-EMS.
- During uphill walking exercise with superimposed WB-EMS.
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS | Young recreationally active males without any disease. Receives: Other: WB-EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Change in energy expenditure (kcal/min) by indirect calorimetry (Vyntus CPX Metabolic Cart)
Measured: It will be continuously measured through the entire test (60 minutes) of electromyostimulation with different impulse frequencies and intensities.
Resting exchange ratio
Change in resting exchange ratio (kcal/min) by indirect calorimetry (Vyntus CPX Metabolic Cart)
Measured: It will be continuously measured through the entire test (60 minutes) of electromyostimulation with different impulse frequencies and intensities.
Secondary outcomes (2)
Pain perception
Change in pain perception in different body structures by Visual Analogue Scales.
Measured: It will be measured at timepoints after the administration of each impulse frequency and before and after the whole application of electromyostimulation.
Impulse intensities
Change in impulse intensities in different body structures by whole-body electromyostimulation device.
Measured: It will be measured with at timepoints after the administration of each impulse frequency.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Oct 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218512
- Sponsor's protocol ID
- Impulse frequencies at rest
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Results will be shared with the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Whole-body Electromyostimulation on Energy Expenditure at Resting and During Uphill Walking in Healthy Young Men
- ClinicalTrials.gov ID
- NCT05218512
- Acronym / sponsor ID
- Impulse frequencies at rest
- Conditions
- Sports Physical Therapy
- Keywords
- Electrical stimulation, Energy expenditure, Obesity, Impulse intensities, Impulse frequencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 1 Feb 2022 (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.
Whole-body electrical stimulation (WB-EMS) has become increasingly popular as a tool to provide additional benefits compared to conventional exercise. However, the effects of the different electrical parameters on energy expenditure (EE) and respiratory exchange ratio (RER) remain poorly understood. This study aims to determine and compare the effects of different electrical frequencies applied with WB-EMS in EE and RER at supine resting and during uphill walking exercise
Detailed description
Obesity is a critical public health problem worldwide since it is a risk factor for cardiovascular diseases and mortality. Increased body weight and obesity are the results of an imbalance between energy intake and energy expenditure (EE). Body weight regulation and obesity are highly influenced by different factors such as genetic, physiology, and socioeconomics. It is well known that physical exercise is an effective strategy to increase EE, improve body composition, physical fitness, and cardiometabolic risk factors. Unfortunately, the principal barriers to abstaining from exercise are time constraints, the risk of injuries, and the lack of enthusiasm observed during the exercise sessions. In this context, whole-body electromyostimulation (WB-EMS) training is becoming increasingly popular worldwide as a potential and attractive alternative to traditional training methods to increase EE. The present study aimed to determine and compare the effects of different electrical frequencies applied with WB-EMS in EE and RER at supine resting and during uphill walking exercise.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WB-EMS | – | Other: WB-EMSYoung recreationally active males without any disease. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We chose recreationally active males without any disease.
Key inclusion criteria (3 listed)
- (i) no previous experience with WB-EMS training
- (ii) having a stable body weight (variation of <5 kg in body weight over the previous 3 months)
- (iii) normal weight (body mass index (BMI) between 18.5-25.0 kg/m2)
Key exclusion criteria (3 listed)
- (i) Suffering from any health problem that might be aggravated by exercise or any contraindications for WB-EMS, such as total endoprosthesis, epilepsy and abdomen/groin hernia
- (ii) Taking medications
- (iii) Chronic metabolic disease or cancer
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 |
|---|---|---|
| WB-EMSThe group has been submitted to 2 experimental conditions: 1. At rest with superimposed WB-EMS. 2. During uphill walking exercise with superimposed WB-EMS. | Other | WB-EMS |
Primary outcome
Energy expenditure
Time frame: It will be continuously measured through the entire test (60 minutes) of electromyostimulation with different impulse frequencies and intensities.
Change in energy expenditure (kcal/min) by indirect calorimetry (Vyntus CPX Metabolic Cart)
Resting exchange ratio
Time frame: It will be continuously measured through the entire test (60 minutes) of electromyostimulation with different impulse frequencies and intensities.
Change in resting exchange ratio (kcal/min) by indirect calorimetry (Vyntus CPX Metabolic Cart)
2 secondary outcomes
Pain perception
Time frame: It will be measured at timepoints after the administration of each impulse frequency and before and after the whole application of electromyostimulation.
Impulse intensities
Time frame: It will be measured with at timepoints after the administration of each impulse frequency.
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 1 Feb 2022.
- Individual participant dataSharing planned: Undecided. Results will be shared with the scientific community.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Physical Therapy, 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 3 inclusion and 3 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 1 Feb 2022. 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. 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?
Energy expenditure (time frame: It will be continuously measured through the entire test (60 minutes) of electromyostimulation with different impulse frequencies and intensities.). The study lists 2 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 1 Feb 2022.