Inspiratory Muscle Training in Amateur Athletes

NCT06611969 | Active Not Recruiting

• 1 other identifier: 2024-FIS-3390079
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amateur Athletes

Keywords

inspiratory muscle training; respiratory function; performance; exercise

Outcome Measures

Primary Outcomes (1)

• Expiratory forced volume in first second

  FEV1, in liters/second, assessed by spirometry

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

Secondary Outcomes (6)

• Hearth rate variability

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

• Hearth rate

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

• Respiratory rate

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

• Running performance

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

• Maximal inspiratory pressure

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

Study Arms (2)

Inspiratory muscle training (IMT) plus conventional training group

EXPERIMENTAL

IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan

Procedure: Exercise

Conventional training group (not-IMT) group

ACTIVE COMPARATOR

The not-IMT group will follow only the conventional marathon training plan

Procedure: Exercise

Interventions

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.

Inspiratory muscle training (IMT) plus conventional training group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Valencia

Valencia, Spain

Location

MeSH Terms

Conditions

Respiratory Aspiration; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Francisco Miguel Martínez Arnau, PhD

  Universitat de Valencia, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluators are unaware of the assignment at all times. Outcomes assessor will discover group assigment after data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiotherapy

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 25, 2024
• Study Start: September 26, 2024
• Primary Completion: January 30, 2025
• Study Completion: July 30, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)