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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Impaired muscle strength

Impaired respiratory system

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Respiratory

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]

Prevention

Intervention code [2]

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]

Half squat will be use as a primary outcome. Speed in meters per second measured with an encoder.

Timepoint [1]

Before and right after the intervention

Primary outcome [2]

Counter movement jump will be another primary outcome. it will be measured with the app my jump2 validated.

Timepoint [2]

Before and right after the intervention

Primary outcome [3]

Forced expiratory volume in the first second (FEV1) will be a respiratory primary outcome. It will be measured with the microRPM device.

Timepoint [3]

Before and right after the intervention

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Madrid

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Universidad Rey Juan Carlos (comité de ética)

Ethics committee address [1]

calle tulipán s/n
28933 Móstoles, Madrid, Spain

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

15/03/2023

Approval date [1]

17/04/2023

Ethics approval number [1]

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

Prof Arturo Ladriñán Maestro

Address

universidad Europea de Madrid
calle Rojas 31
45400 Mora Toledo

Country

Spain

Phone

+34 615274176

Fax

arturo.ladrinan@uclm.es

Contact person for public queries

Name

Alberto Sánchez Sierra

Address

Universidad Europea de Madrid
AV tajo s/n
28670 Villaviciosa de Odón
Madrid/Spain

Country

Spain

Phone

+34 608801238

Fax

alberto.sanchez@universidadeuropea.es

Contact person for scientific queries

Name

Alberto Sánchez Sierra

Address

Universidad Europea de Madrid
AV tajo s/n
28670 Villaviciosa de Odón
Madrid/Spain

Country

Spain

Phone

+34 608801238

Fax

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.	Type	Email	Attachment
19253	Study protocol	Arturo.ladrinan@uclm.es	385962-(Uploaded-11-07-2023-01-33-28)-Study-related document.docx
19254	Informed consent form	Arturo.ladrinan@uclm.es	385962-(Uploaded-11-07-2023-01-33-52)-Study-related document.docx
19255	Ethical 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.

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