Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000754640
Ethics application status
Approved
Date submitted
25/05/2023
Date registered
11/07/2023
Date last updated
11/07/2023
Date data sharing statement initially provided
11/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of inspiratory muscle fatigue on leg muscles and respiratory capacity.
Scientific title
Influence of a diaphragmatic fatigue protocol on
healthy population on muscle strength, respiratory function
and exercise capacity.
Secondary ID [1] 309741 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired muscle strength 330137 0
Impaired respiratory system 330138 0
Condition category
Condition code
Musculoskeletal 327018 327018 0 0
Other muscular and skeletal disorders
Respiratory 327019 327019 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of the study is to demonstrate how diaphragmatic fatigue influences sports performance acutely.
The sample will be divided into two groups. "The fatigue group" and the "active group"

All participants will familiarize themselves with the use of the inspiratory muscle training devices before the test to avoid problems and loss of time.
All participants will be evaluated for their respiratory capacity with the values of the forced expiratory volume in the first second (FEV1) and the ratio between FEV1 and forced vital capacity using the Air Smart Spirometer (Pond healthcare innovation,Sweeden)

Afterwards they will perform a conventional warm-up for 10 minutes( 5 minutes on a monark bike,lower limb mobility exercises, skipping rope jumps for one minute and low load squat exercises)
afterwards they will perform a half squat at maximum speed measured with the vitruve encoder. They will make 3 attempts with a 3-minute break between attempts and the best will be recorded.
Then they will perform a counter movement jump and it will be measured with the myjump2 app. Here they will also make 3 attempts with 3 minutes rest between attempts and the best jump will be recorded.
The tests and the warm up were performed by to expert physical therapist with more than 10 years of experience.

Once they have finished the tests, each participant will go to the assigned group to carry out the intervention.

Fatigue group: will train the diaphragm overcoming resistance through a training device for the inspiratory muscles.The device (Big breathe GH innotek Co,Ltd Busan,Republic of Korea) will apply a resistance when the subject wants to inhale so the diaphragm will need to perform a stronger contraction. They will have to perform as many repetitions as possible until they are unable to overcome said resistance (50% of the maximum inspiratory pressure). It will be around 60 repetitions which will take 3 minutes to arrive to fatigue. The maximum inspiratory pressure will be measured with the microRPM device which is used in most of the investigation.
This exercise will be done just one time, because we want to see the immediate effects of the diaphragm once it is fatigue in the muscles of the lower limbs.
Once the diaphragm is fatigued (the participant is not able to break the resistance of the training device) the initial test will be done again.
The respiratory capacity tests, the half squat test and the counter movement jump test
At this point the intervention will be finished.
The total intervention time will be around 30 minutes per participant
Intervention code [1] 326181 0
Prevention
Intervention code [2] 326182 0
Treatment: Devices
Comparator / control treatment
The activation of the diaphragm has shown improvements in the past in runners, We will use the same protocol for the control group to also check if there is any benefit in lower limb strength tests.

Once they have perform the warm up for 10 minutes( 5 minutes on a monark bike,lower limb mobility exercises, skipping rope jumps for one minute and low load squat exercises)
All participants will be evaluated for their respiratory capacity with the values of the forced expiratory volume in the first second (FEV1) and the ratio between FEV1 and forced vital capacity using the Air Smart Spirometer (Pond healthcare innovation,Sweeden)

Afterwards they will perform a conventional warm-up for 10 minutes( 5 minutes on a monark bike,lower limb mobility exercises, skipping rope jumps for one minute and low load squat exercises)
afterwards they will perform a half squat at maximum speed measured with the vitruve encoder. They will make 3 attempts with a 3-minute break between attempts and the best will be recorded.
Then they will perform a counter movement jump and it will be measured with the myjump2 app. Here they will also make 3 attempts with 3 minutes rest between attempts and the best jump will be recorded.
The tests and the warm up were performed by to expert physical therapist with more than 10 years of experience.
Once they have finished the tests, each participant will go to the assigned group to carry out the intervention.

Active group: they will perform 2 series of 30 repetitions at 15% of their maximum inspiratory pressure using the device (Big breathe GH innotek Co,Ltd Busan,Republic of Korea) with the aim of activating the diaphragmatic muscles (just the opposite objective of the other group). their maximal inspiratory pressure that was calculated with the microRPM device which is used in most of the investigation.
Just after they have finished the 2 series they will repeat the test in the same order as before.
this will take around 30 minutes to each participant.
Control group
Active

Outcomes
Primary outcome [1] 334877 0
Half squat will be use as a primary outcome. Speed in meters per second measured with an encoder.
Timepoint [1] 334877 0
Before and right after the intervention
Primary outcome [2] 334878 0
Counter movement jump will be another primary outcome. it will be measured with the app my jump2 validated.
Timepoint [2] 334878 0
Before and right after the intervention
Primary outcome [3] 334879 0
Forced expiratory volume in the first second (FEV1) will be a respiratory primary outcome. It will be measured with the microRPM device.
Timepoint [3] 334879 0
Before and right after the intervention
Secondary outcome [1] 422320 0
Forced expiratory volume on the first second and the forced vital capacity ratio. (primary outcome). It will be measured with the microRPM device at the same time, The device will calculate both values in one test.
Timepoint [1] 422320 0
Before and right after the intervention

Eligibility
Key inclusion criteria
-Be 18 years old or older and younger than 46 years old
-Non smoking person (at least 1 year)
-Practice any physical activity at least 3 times a week for minimum one year
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Suffered an injury than doesn't allow the participant to perform physical activity
-Cognitive deterioration problems
-Cardiovascular and respiratory pathologies
-Hypertension
-Surgery intervention in lower limbs the last 12 months
-Active episodes of lower limb pain

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer program (office excel)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative variables will be expressed as absolute number and percentage and quantitative variables as mean ± standard deviation if they follow a normal distribution or as median and interquartile range (IQR) if they do not. To verify the normality of the data distributions, the Kolmogorov-Smirnov or Shapiro Wilk test will be used. For the comparison of qualitative variables, the chi square test or Fisher's exact test will be used when necessary. For the comparison of quantitative variables, the Student's t test will be used if it follows a normal distribution or the Mann-Whitney U test otherwise. P values lower than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2023
Actual
Date of last participant enrolment
Anticipated
18/07/2023
Actual
Date of last data collection
Anticipated
21/07/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 25555 0
Spain
State/province [1] 25555 0
Madrid

Funding & Sponsors
Funding source category [1] 313930 0
Self funded/Unfunded
Name [1] 313930 0
Country [1] 313930 0
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
AV tajo s/n (without number)
28670 Villaviciosa de Odón
Madrid/Spain
Country
Spain
Secondary sponsor category [1] 315794 0
None
Name [1] 315794 0
Address [1] 315794 0
Country [1] 315794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313075 0
Universidad Rey Juan Carlos (comité de ética)
Ethics committee address [1] 313075 0
calle tulipán s/n
28933 Móstoles, Madrid, Spain
Ethics committee country [1] 313075 0
Spain
Date submitted for ethics approval [1] 313075 0
15/03/2023
Approval date [1] 313075 0
17/04/2023
Ethics approval number [1] 313075 0
2501202306223

Summary
Brief summary
The benefits obtained from respiratory muscle training can not only be used in respiratory patients (COPD, bronchiectasis, etc.), but also in the athlete population that wants to improve their cardiorespiratory fitness, that is, their performance. This is because a high metabolic workload, either due to pathology or overexertion in training, causes what is called the Respiratory Metabolic Reflex, which consists of a neural response from the sympathetic nervous system that causes vasoconstriction. reflex of the skeletal muscles and a consequent redirection of blood flow to the respiratory muscles to meet their metabolic demands, the physical sensation is that the legs are failing. There are numerous publications in the literature on the training of the respiratory muscles, together with protocols that indicate improvements in the cardiorespiratory conditions of patients with respiratory disease and in those athletes who want to improve their cardiorespiratory condition in general.
Our study consists of inducing diaphragmatic fatigue in the same session in healthy subjects. In order to observe the existing relationship of diaphragmatic fatigue with muscle strength as the main objective and with the capacity for exercise through the use of different tests,

Hypothesis
Carrying out a protocol that involves diaphragmatic fatigue in healthy subjects could intervene in muscle strength, respiratory function, and cardiorespiratory capacity.

Goals
General objective
Determine if there is a relationship between diaphragmatic fatigue and muscle strength in the lower limbs.
Specific objectives
To determine if there is a relationship between diaphragmatic fatigue and lung function.
To determine if there is a relationship between diaphragmatic fatigue and the maximum inspiratory force (MIP).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126906 0
Prof Arturo Ladriñán Maestro
Address 126906 0
universidad Europea de Madrid
calle Rojas 31
45400 Mora Toledo
Country 126906 0
Spain
Phone 126906 0
+34 615274176
Fax 126906 0
Email 126906 0
arturo.ladrinan@uclm.es
Contact person for public queries
Name 126907 0
Dr Alberto Sánchez Sierra
Address 126907 0
Universidad Europea de Madrid
AV tajo s/n
28670 Villaviciosa de Odón
Madrid/Spain
Country 126907 0
Spain
Phone 126907 0
+34 608801238
Fax 126907 0
Email 126907 0
alberto.sanchez@universidadeuropea.es
Contact person for scientific queries
Name 126908 0
Dr Alberto Sánchez Sierra
Address 126908 0
Universidad Europea de Madrid
AV tajo s/n
28670 Villaviciosa de Odón
Madrid/Spain
Country 126908 0
Spain
Phone 126908 0
+34 608801238
Fax 126908 0
Email 126908 0
alberto.sanchez@universidadeuropea.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
Principal Investigator ( (Arturo.ladrinan@uclm.es)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19253Study protocol  Arturo.ladrinan@uclm.es 385962-(Uploaded-11-07-2023-01-33-28)-Study-related document.docx
19254Informed consent form  Arturo.ladrinan@uclm.es 385962-(Uploaded-11-07-2023-01-33-52)-Study-related document.docx
19255Ethical approval  Arturo.ladrinan@uclm.es 385962-(Uploaded-25-05-2023-22-20-50)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.