Respiratory Muscle Training Trial, ANZCTR, Spain, Recruiting

Trial Review

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Registration number

ACTRN12626000510347 Ethics application status

Approved Date submitted

12/11/2025 Date registered

23/04/2026 Date last updated

23/04/2026 Date data sharing statement initially provided

23/04/2026 Type of registration

Retrospectively registered
Titles & IDs Public title Effect of Different Instructional Strategies on Respiratory Muscle Performance Query! Scientific title The Impact of Different Instructional Strategies on Respiratory Muscle Activation During Training in Healthy Adults Query! Additional trial identifiers [1] 316464 0 None Query! Universal Trial Number (UTN) Query! Trial acronym EMV-Instruction Query! Related trial records Query!
Health condition Health condition(s) studied: Functioning of the respiratory muscles in healthy adults 339555 0 Query! Condition category Condition code Respiratory 335799 335799 0 0 Query! Normal development and function of the respiratory system Query!

Intervention/exposure Study type Interventional Query! Description of the intervention or exposure Participants will perform ventilatory muscle training (VMT) using the POWERbreathe Kinetic K5 device in four experimental conditions:
1. Control: no additional instructions (only basic technical instructions).
2. Explicit instruction: verbal instructions focused on the body (e.g., ‘expand your rib cage without raising your shoulders’).
3. Instruction by analogy: viewing a video of a balloon expanding inside a rib cage, asking the participant to replicate that pattern.
4. External focus: instruction to concentrate on improving the values shown on the screen during inspiration.

The POWERbreathe Kinetic K5 is an electronic inspiratory muscle training (IMT) device that provides variable and controlled resistance during inspiration. It uses an electronic valve that adjusts the load based on the user's inspiratory flow, allowing for precise, progressive and reproducible training, as well as recording parameters such as inspiratory pressure, volume and power.
Participants perform respiratory training by breathing in through the device's mouthpiece, usually in a seated position.
During the sessions, they are instructed to take deep, controlled breaths following the established protocol (number of breaths, sets and breaks), while the device monitors and stores the training data.
The instructions will be provided by the investigator.
results collected by POWERbreathe Kinetic K5 displayed on a television screen in front of participants, etc.
The study is randomised.

The duration of each session was approximately 30 minutes per participant.
The ventilatory muscle training (VMT) focused specifically on the accessory muscles of inspiration: the sternocleidomastoid and the scalenes. The sternocleidomastoid acts to elevate the sternum, while the scalene muscles elevate the first and second ribs. Together, they expand the upper thoracic cavity during increased ventilatory demand. The training involved exercises designed to target and engage these specific muscle groups.
The intervention was administered by an investigator who is a Professor at the University of Seville, holding a degree in Sports Science and Physical Activity.
No video was used or shown during the 'instruction by analogy' condition. The instruction relied entirely on the participants' own mental imagery and internal visualization.
All participants began the study by completing the control condition first. Following the control session, the remaining three conditions were assigned to each participant in a randomized order.
For both the 'explicit instruction' and 'instruction by analogy' conditions, the instructions are provided only once during the 30-minute session. The exact timepoint at which this single instruction is delivered depends on the randomized sequence of the instructional strategies assigned to the participant. Query! Intervention code [1] 332427 0 Treatment: Other Query! Description of the comparator or control Control: no additional instructions (only basic technical instructions). Query! Control group Active Query!
Outcomes Primary outcome [1] 343336 0 Inspiratory muscle activity Query! Timepoint [1] 343336 0 Continuously and immediately during each experimental condition phase Query! Secondary outcome [1] 454096 0 Inspired volume Query! Timepoint [1] 454096 0 continuous monitoring during the inspiratory phase of each experimental condition Query!
Eligibility Key inclusion criteria Healthy adults, men and women.
Non-smokers (last 12 months).
No current clinical diagnosis of respiratory disease.
No injuries that limit maximum ventilatory effort.
Not practising federated endurance sports (>4 days/week).
Not having performed moderate-high physical activity in the last 24 hours. Query! Minimum age 18 Years Query! Query! Maximum age No limit Query! Query! Sex Both males and females Query! Can healthy volunteers participate? Yes Query! Key exclusion criteria None Query!
Study design Purpose of the study Treatment Query! Allocation to intervention Randomised controlled trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures) central randomisation by computer Query! Methods used to generate the sequence in which subjects will be randomised (sequence
generation) Assignment was randomly created by software Query! Masking / blinding Query! Who is / are masked / blinded?

Query! Query! Query! Query! Intervention assignment Query! Other design features Query! Phase Not Applicable Query! Type of endpoint/s Query! Statistical methods / analysis Query!
Recruitment Recruitment status Recruiting Query! Date of first participant enrolment Anticipated Query! Actual 16/12/2025 Query! Date of last participant enrolment Anticipated Query! Actual Query! Date of last data collection Anticipated Query! Actual Query! Sample size Target 24 Query! Accrual to date 1 Query! Final Query! Recruitment outside Australia Country [1] 27588 0 Spain Query! State/province [1] 27588 0 Sevilla Query!
Funding & Sponsors Funding source category [1] 320413 0 University Query! Name [1] 320413 0 Universidad de Sevilla Query! Country [1] 320413 0 Spain Query! Primary sponsor type University Query! Name Universidad de Sevilla Query! Address Query! Country Spain Query! Secondary sponsor category [1] 323503 0 None Query! Name [1] 323503 0 Query! Address [1] 323503 0 Query! Country [1] 323503 0 Query!
Ethics approval Ethics application status Approved Query! Ethics committee name [1] 318959 0 Comité de Ética de la Investigación de la Universidad de Sevilla (CEIUS) Query! Ethics committee address [1] 318959 0 Biblioteca de la Universidad de Sevilla · Avda. de la Guardia Civil s/n, C.P. 41013-Sevilla, España Query! Ethics committee country [1] 318959 0 Spain Query! Date submitted for ethics approval [1] 318959 0 07/11/2025 Query! Approval date [1] 318959 0 26/11/2025 Query! Ethics approval number [1] 318959 0 Query!
Summary Brief summary The main objective of the study is to analyse the effects of different instruction strategies on respiratory muscle performance, determine whether different strategies generate differences in the muscle activation of primary and accessory muscles during ventilatory muscle training, and compare the effects of different instruction strategies on participants' preferences. Among the hypotheses, we find whether different types of instruction will have a higher maximum performance or whether instruction will cause a reorganisation in muscle activity. Query! Trial website Query! Trial related presentations / publications Query! Public notes Query!
Contacts Principal investigator Name 145810 0 Mr Jordi Villa Pérez Query! Address 145810 0 Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA Query! Country 145810 0 Spain Query! Phone 145810 0 +34685736424 Query! Fax 145810 0 Query! Email 145810 0 [email protected] Query! Contact person for public queries Name 145811 0 Jordi Villa Pérez Query! Address 145811 0 Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA Query! Country 145811 0 Spain Query! Phone 145811 0 +34685736424 Query! Fax 145811 0 Query! Email 145811 0 [email protected] Query! Contact person for scientific queries Name 145812 0 Jordi Villa Pérez Query! Address 145812 0 Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA Query! Country 145812 0 Spain Query! Phone 145812 0 +34685736424 Query! Fax 145812 0 Query! Email 145812 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? Yes
Will there be any conditions when requesting access to individual participant data? Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared? • All de-identified individual participant data
What types of analyses could be done with individual participant data? • Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)? From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly? • Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data? No

What supporting documents are/will be available?

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.