Inspiratory Muscle Training in Amateur Athletes

Effects of Inspiratory Muscle Training As a Complement to Usual Training on Respiratory Function and Performance 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Amateur Athletes
• Intervention / Treatment: Procedure: Exercise; Procedure: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory muscle training (IMT) plus conventional training group; IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan	Procedure: Exercise; 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.; Procedure: Exercise; The training programme will consist of 5 weekly sessions of aerobic work, strength and mobility.
Active Comparator: Conventional training group (not-IMT) group; The not-IMT group will follow only the conventional marathon training plan	Procedure: Exercise; 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.; Procedure: Exercise; The training programme will consist of 5 weekly sessions of aerobic work, strength and mobility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory forced volume in first second	FEV1, in liters/second, assessed by spirometry	Before starting the intervention and after its completion (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearth rate variability	In miliseconds, assessed by hearth rate monitor	From the beginning to the end of the programme, recorded on a daily basis.
Hearth rate	Maximal and specifically in rest, measured in beats per minute, assessed by heart rate monitor	From the beginning to the end of the programme, recorded on a daily basis.
Respiratory rate	Measured in respirations per minute, estimated by the hearth rate monitor.	From the beginning to the end of the programme, recorded on a daily basis.
Running performance	Measured by running pace (time per kilometre) and perceived exertion (modified Borg scale 0-10), recorded individually in a written register.	From the beginning to the end of the programme, recorded on a daily basis.
Maximal inspiratory pressure	MIP, in cmH2O, assessed by inspiratory manouever	Before starting the intervention and after its completion (12 weeks)
Maximal consumption of oxygen	VO2 max, in ml/kg/min, estimated by heart rate monitor in training efforts.	Before starting the intervention and after its completion (12 weeks)

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Study Director: Francisco Miguel Martínez Arnau, PhD, Universitat de Valencia, Spain

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: exercise; inspiratory muscle training; performance; respiratory function
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2024-FIS-3390079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No