The Effect of Inspiratory Muscle Warm-up on Decreased Diffusing Capacity for Carbon Monoxide After Maximal Exercise in Athletes

NCT ID: NCT06751511

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-01-30

Brief Summary

This study aims to examine the effects of inspiratory muscle warm-up (IMW) on the gas exchange capacity of the lungs (DLCO) and its potential contribution to recovery and athletic performance in elite athletes from various disciplines. The study hypothesizes that the decline in respiratory muscle capacity following high-intensity exercise, which negatively affects ventilation, diffusion, and oxygen transport, may be ameliorated through specific IMW protocol. A placebo-controlled, randomized, crossover, and double-blind design will be utilized, involving 28 elite male athletes from endurance, power, skill-based, and mixed disciplines.

Participants will complete three warm-up protocols: General Warm-up (GW), General Warm-up combined with IMW at 40% resistance intensity (GW+IMW40%), and a placebo condition (GW+IMWplacebo). Measurements will include respiratory muscle strength, DLCO (assessed at post-2, 30, 60, 90, and 120 minutes), respiratory function, and cardiorespiratory parameters during maximal exercise. This study is unique as it aims to detail the micro-level effects of IMW on pulmonary diffusion mechanisms and performance outcomes, providing novel insights into the ameliorative effects of IMW on respiratory function post-exercise. Additionally, it seeks to expand understanding of the mechanistic basis of IMW's benefits on both pulmonary diffusion capacity and athletic performance.

Detailed Description

STUDY DESIGN This study will employ a placebo-controlled, randomized, crossover, and double-blind research design to evaluate the effects of three warm-up conditions: Control, Placebo 15%, and IMW 40%. Athletes will be randomly assigned to the conditions using a crossover approach, ensuring that all participants will experience each protocol on separate days.

The warm-up protocols will include:

General Warm-up (Control): A standard warm-up without resistance. IMW 40%: A general warm-up combined with inspiratory muscle warm-up at 40% resistance intensity.

Placebo 15%: A general warm-up combined with inspiratory muscle warm-up (placebo) at 15% resistance intensity.

Blinding will be maintained for both participants and researchers. Participants will be informed that the study aims to investigate various warm-up types, while the true purpose will remain concealed. This design will ensure reliability and minimize bias in the data to be collected.

Conditions

Athlete

Keywords

warm-up; inspiratory muscle warm-up; respiratory muscle warm-up

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control

Participants only performed a general warm-up exercise.

Group Type: OTHER

General warm-up

Intervention Type: OTHER

The General Warm-up (Control) protocol will consist of activities such as running and dynamic, active, and passive movements, adapted to suit the varied sports disciplines included in the study. These exercises will align with the principles of elevation, activation, and mobilization, aiming to enhance mobility across key muscle groups, from the arms and shoulders to the lower back and legs. Each session will include clear demonstrations to ensure proper technique and pacing, with participants performing a standardized number of repetitions. Researchers will supervise participants closely to verify accurate form and consistent execution during the intervention.

IWM %15 Placebo

In addition to the general warm-up, the participants performed IMW at 15% resistance intensity.

Group Type: PLACEBO_COMPARATOR

Inspiratory muscle warm-up (Placebo - %15)

Intervention Type: OTHER

The placebo inspiratory muscle warm-up protocol will utilize the POWERbreathe® device at 15% of maximal inspiratory pressure (MIP). This placebo protocol will consist of two sets of 30 breaths, separated by a 60-second rest interval, with participants seated and wearing a nose clip. Proper technique will be taught during a prior familiarization session, and participants will be closely monitored during testing to ensure accurate execution. This protocol is designed to function as a placebo, effectively concealing the study's true objective to improve data validity and reliability.

IWM %40 Intervention

In addition to the general warm-up, participants performed IMW at 40% resistance intensity.

Group Type: ACTIVE_COMPARATOR

Inspiratory muscle warm-up (%40 IMW)

Intervention Type: OTHER

This study will implement a respiratory muscle warm-up protocol at 40% of maximal inspiratory pressure (MIP) using the POWERbreathe® device, as this intensity is considered optimal for effectively stimulating respiratory muscles. The protocol will consist of two sets of 30 breaths, with a 60-second rest period between sets, conducted while participants are seated and wearing a nose clip. Training for proper technique will be provided during the familiarization session, and participants will be closely monitored throughout the tests to ensure correct and consistent execution.

Interventions

General warm-up

The General Warm-up (Control) protocol will consist of activities such as running and dynamic, active, and passive movements, adapted to suit the varied sports disciplines included in the study. These exercises will align with the principles of elevation, activation, and mobilization, aiming to enhance mobility across key muscle groups, from the arms and shoulders to the lower back and legs. Each session will include clear demonstrations to ensure proper technique and pacing, with participants performing a standardized number of repetitions. Researchers will supervise participants closely to verify accurate form and consistent execution during the intervention.

Intervention Type: OTHER

Inspiratory muscle warm-up (Placebo - %15)

The placebo inspiratory muscle warm-up protocol will utilize the POWERbreathe® device at 15% of maximal inspiratory pressure (MIP). This placebo protocol will consist of two sets of 30 breaths, separated by a 60-second rest interval, with participants seated and wearing a nose clip. Proper technique will be taught during a prior familiarization session, and participants will be closely monitored during testing to ensure accurate execution. This protocol is designed to function as a placebo, effectively concealing the study's true objective to improve data validity and reliability.

Intervention Type: OTHER

Inspiratory muscle warm-up (%40 IMW)

This study will implement a respiratory muscle warm-up protocol at 40% of maximal inspiratory pressure (MIP) using the POWERbreathe® device, as this intensity is considered optimal for effectively stimulating respiratory muscles. The protocol will consist of two sets of 30 breaths, with a 60-second rest period between sets, conducted while participants are seated and wearing a nose clip. Training for proper technique will be provided during the familiarization session, and participants will be closely monitored throughout the tests to ensure correct and consistent execution.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18-24 years.
• A training history of at least six years.
• Regular training frequency of at least four sessions per week.

Exclusion Criteria

• History of smoking.
• History of physical disability or acute respiratory or cardiovascular disease within the past three months.
• Diagnosis of SARS-CoV-2 within the past three months.
• Pulmonary function measurements outside the normal clinical range (≤ 80%).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Emre Karaduman

OTHER

Sponsor Role: lead

Responsible Party

Emre Karaduman

Research Asistant

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Emre Karaduman, Ph.D

Role: CONTACT

Phone: +90 5433021991

Email: emre.karaduman@omu.edu.tr

Other Identifiers

2023/473

Identifier Type: -

Identifier Source: org_study_id