Muscle OxigenationNCT02695017
Changes in Oxygen Saturation in Two Exercise Modalities
A study testing Iso inertial and Conventional machine in people with Muscle Oxigenation and Strength, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
The investigator will proceed to assess changes in oxygenation of muscle tissue, electromyographic activation and strength in healthy subjects. For this, a measurement of all demographic variables on the first day of the study as well as a familiarity with the equipment will be performed. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Oxigenation, Strength
- What is being tested?
- Iso inertial and Conventional machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Oct 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary
- No pain
- Non disease
Who cannot join
- Exercise experience
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Changes in Oxygen Saturation in Flywheel Exercise Versus Conventional Strength Machine
The investigator will proceed to assess changes in oxygenation of muscle tissue, electromyographic activation and strength in healthy subjects. For this, a measurement of all demographic variables on the first day of the study as well as a familiarity with the equipment will be performed. Participants will start the intervention 48 hours later to proceed with the first intervention with one of the exercises in this research (inertial pulley or regular machine). Later on, 48 hours later participants will perform the latest intervention that has not yet done, thus generating a crossover study.
- Conditions
- Muscle Oxigenation, Strength
- Being tested
- Iso inertial, Conventional machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iso inertialDevice
Conventional machineDevice
| Study group | Role | What they receive |
|---|---|---|
| Iso inertial | Experimental | Subjects should do 12 exercise repetition with Iso inertial machine Receives: Device: Iso inertial |
| Conventional machine | Experimental | Subjects should do 12 exercise repetition with conventional machine Receives: Device: Conventional machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Oxygen saturation of Vastus lateralis muscle during the exercise of each participant
physiological parameter (Percentage of local oxygen consume will be record in every stage of the investigation)
Measured: one second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle OxigenationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Muñoz-Garcia, Centro Universitario La Salle
- Investigators
- Daniel Muñoz, MSc, Principal investigator, Centro La Salle Universitario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695017
- Sponsor's protocol ID
- CSEULS-PI-086
- Status last verified
- Sep 2018
- First submitted
- 8 Feb 2016
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Research publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Changes in Oxygen Saturation in Flywheel Exercise Versus Conventional Strength Machine
- ClinicalTrials.gov ID
- NCT02695017
- Acronym / sponsor ID
- CSEULS-PI-086
- Conditions
- Muscle Oxigenation, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Mar 2016 (estimated)
- 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 investigator will proceed to assess changes in oxygenation of muscle tissue, electromyographic activation and strength in healthy subjects. For this, a measurement of all demographic variables on the first day of the study as well as a familiarity with the equipment will be performed. Participants will start the intervention 48 hours later to proceed with the first intervention with one of the exercises in this research (inertial pulley or regular machine). Later on, 48 hours later participants will perform the latest intervention that has not yet done, thus generating a crossover study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iso inertial | Experimental | Device: Iso inertialSubjects should do 12 exercise repetition with Iso inertial machine |
| Conventional machine | Experimental | Device: Conventional machineSubjects should do 12 exercise repetition with conventional machine |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary
- No pain
- Non disease
Key exclusion criteria (1 listed)
- Exercise experience
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 |
|---|---|---|
| Iso inertial | Device | Iso inertial |
| Conventional machine | Device | Conventional machine |
Primary outcome
Percentage of Oxygen saturation of Vastus lateralis muscle during the exercise of each participant
Time frame: one second
physiological parameter (Percentage of local oxygen consume will be record in every stage of the investigation)
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 24 Sep 2018.
- Individual participant dataSharing planned: Yes. Research publication
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.
Daniel Muñoz, MSc principal investigator
Centro La Salle Universitario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iso inertial and Conventional machine in people with Muscle Oxigenation and Strength, run by Centro Universitario La Salle 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 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 24 Sep 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. 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?
Percentage of Oxygen saturation of Vastus lateralis muscle during the exercise of each participant (time frame: one second). 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 24 Sep 2018.