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Active, Not Recruiting

NCT Number: NCT06611969

Inspiratory Muscle Training in Amateur Athletes

The main objective of the study is to study the changes in FEV1 with the introduction of the specific inspiratory muscle training programme in the training programme of the popular athletes included. In addition, the secondary aims are to observe the differences in the respiratory capacities of the patients, in the vital signs, VO2 max, respiratory frequency and cardiac variability, as well as to assess the running performance of the participants.

Participants will be assigned to one of 2 study groups: IMT group (n=20) or not-IMT group (n=20) The IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan. The not-IMT group will follow only the conventional marathon training plan. The study will be conducted over a 12 week period.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valencia

Valencia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals willing to follow the 16-week running training plan
  • Possibility of combining aerobic training with inspiratory muscle training
  • Previous half marathon runner

Exclusion criteria

  • - Exclusive or professional dedication to athletics
  • Previous or current use of respiratory muscle training.
  • Inadequate or health risk physical condition
  • Significant chronic cardiorespiratory diagnoses (e.g. moderate-severe COPD).
  • Neurological, muscular or neuromuscular problems that interfere with the ability to participate in tests and training protocols.
  • Discontinuity in the performance of training.
  • A terminal illness or any other major medical contraindication
  • Lack of informed consent

Treatment and study plan

Exercise

Procedure

The training programme will consist of 5 weekly sessions of aerobic work, strength and mobility, plus specific training of the inspiratory muscles, 3 times a week, at a load between 50 and 80% of the maximum inspiratory pressure of each participant, after re-education of their diaphragmatic ventilation.

Primary outcomes

  1. Expiratory forced volume in first second

    Time frame: Before starting the intervention and after its completion (12 weeks)

    FEV1, in liters/second, assessed by spirometry

Secondary outcomes

  1. Hearth rate variability

    Time frame: From the beginning to the end of the programme, recorded on a daily basis.

    In miliseconds, assessed by hearth rate monitor

  2. Hearth rate

    Time frame: From the beginning to the end of the programme, recorded on a daily basis.

    Maximal and specifically in rest, measured in beats per minute, assessed by heart rate monitor

  3. Respiratory rate

    Time frame: From the beginning to the end of the programme, recorded on a daily basis.

    Measured in respirations per minute, estimated by the hearth rate monitor.

  4. Running performance

    Time frame: From the beginning to the end of the programme, recorded on a daily basis.

    Measured by running pace (time per kilometre) and perceived exertion (modified Borg scale 0-10), recorded individually in a written register.

  5. Maximal inspiratory pressure

    Time frame: Before starting the intervention and after its completion (12 weeks)

    MIP, in cmH2O, assessed by inspiratory manouever

  6. Maximal consumption of oxygen

    Time frame: Before starting the intervention and after its completion (12 weeks)

    VO2 max, in ml/kg/min, estimated by heart rate monitor in training efforts.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training As a Complement to Usual Training on Respiratory Function and Performance in Amateur Athletes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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