跳至主要内容
临床试验/NCT06807957
NCT06807957招募中不适用

Effectiveness of Inspiratory Muscle Training on Respiratory Muscle Strength and Physical Performance in Amateur CrossFit® Athletes: A Randomized Controlled Trial

Federal University of the Valleys of Jequitinhonha and Mucuri2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
94
试验地点
2
主要终点
Effectiveness of TMI on race performance: 25 calorie expenditure on the Air Bike

研究概览

简要总结

The aim of this randomized controlled trial is to investigate the effectiveness of inspiratory muscle training (IMT) on the performance of athletes in CrossFit® activities, respiratory muscle strength, and perceived post-training fatigue. This study follows a two-arm randomized controlled trial protocol. Ninety-four volunteers aged between 18 and 60 years, enrolled in CrossFit® training, will be randomly allocated to the IMT Group, which involves respiratory training using a linear load device (Powerbreathe®) in conjunction with CrossFit® training; or the Non-IMT Group, which undergoes the same training as the intervention group but uses a device without a valve that ensures resistance. The primary outcome is to investigate the effectiveness of IMT: on maximum inspiratory pressure and maximum expiratory pressure. The secondary outcomes include performance in the six-minute walk test, Pistol, Burpee, Sit-up, Box Jump, Thruster, and Single-Under, burning 25 calories on the "Air Bike" measured by the time taken to reach the 25-calorie mark on this equipment, as well as the assessment of subjective fatigue perception. All outcomes of interest will be collected at baseline and reassessed: mid-term (8 weeks after allocation); and long-term (12 weeks after allocation), the IMT and MEP will be reassessed. Analyses will follow the intention-to-treat principle. Treatment effects will be assessed using Linear Mixed Models. The results of this study may help clarify the effects of IMT on CrossFit® athletes.

详细描述

Study design: This is a prospective randomized controlled trial with two arms. The study was registered with the Research Ethics Committee of the Universidade Federal dos Vales do Jequitinhonha e Mucuri (UFVJM): 81443024.9.0000.5108. Procedures and data collection: Participants who seek the CrossFit® service and enroll, as well as those who are already enrolled, will be invited to participate in this study. All eligible participants will receive information about the study and must sign an informed consent form before participating. The initial assessment and reassessment of the participant will take place at Academia Compasso Sete Lagoas (Boa Vista Unit and/or Centro Unit). The data collected will be: age, height, weight, body mass (BM), Body Mass Index (BMI), heart rate, blood pressure, gender, smoking history (yes/no), medications in use, time practicing the sport and the presence of any comorbidities. All outcomes of interest (respiratory muscle strength, subjective perception of fatigue and results obtained in CrossFit® exercises) will be collected at baseline and reassessed at the following time points: medium term (8 weeks after allocation) and long term (12 weeks after allocation), in an assessment room at the gym. The collected data will initially be entered into a standardized data collection form and then transferred to an Excel table.

The evaluation process will be divided as follows: first, the participant will complete the evaluation form, and then their MIP and MEP values will be collected. Next, the first evaluation test will be performed: "Air Bike" (25 calories); then the evaluation sequence will be performed: Sit-up, Pistol, Burpee, Box Jump, 6MWT, Thruster, and Single-Under. Additionally, after completing all the exercises on the second day of evaluation, the Borg Scale will be administered.

The randomization sequence for the experimental and control groups, with an allocation ratio of 1:1, will be generated by a computer program by one of the researchers who will not be involved in the recruitment of participants. The groups will be coded and the allocation will be transferred to a series of sealed and sequentially numbered opaque envelopes. Two evaluators participated in this stage of the research: researcher 1 will be responsible for the evaluations; and researcher 2 for randomization and distribution of equipment.

Group with TMI: CrossFit® training: participants will be guided and encouraged to attend at least 5 days of training. TMI: the device used for the intervention will be the POWERbreathe®. The load used will be 50% of MIP. The TMI will be performed in two series of 30 breaths through the mouth through the mouthpiece connected to the POWERbreathe®, with a 1-minute interval between series.

Group without TMI: participants allocated to the "No TMI Group" will receive the same interventions as the "Group with TMI", but without the respiratory training included. In addition, they will also perform the TMI in a simulated manner.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60 years;
  • Be enrolled in a CrossFit® program;
  • Be available to perform TMI at home 5 days a week.

排除标准

  • Have any musculoskeletal, cardiovascular and/or neurological condition that prevents CrossFit® and/or IMT from being performed;
  • Be a smoker;
  • Not sign the Termo de Consentimento Livre Esclarecido (TCLE);
  • Be performing or have performed IMT using linear load equipment in the last month.

研究组 & 干预措施

Group with IMT

Experimental

CrossFit® Training: ParticipaIMT: The intervention will utilize the POWERbreathe® device. Participants will be provided with the device for home training. The model selected for this study is the POWERbreathe® Classic Medium Resistance (Fitness).

The load will be set at 50% of each participant's MIP, as determined during the assessment phase using a vacuum manometer. IMT will be performed in two sets of 30 breaths through a mouthpiece connected to the POWERbreathe®, with a one-minute rest between sets. Participants will complete the training five days per week at home over the course of eight weeks. Additionally, participants will monitor their adherence by completing a log sheet to mark training days. To ensure proper use and management of the device, each participant will receive individual training after randomization. At the end of the eight weeks, participants will return the equipment to the research team for cleaning and redistribution to another participant in the same group.

干预措施: CrossFit® Training (Behavioral)

Group with IMT

Experimental

CrossFit® Training: ParticipaIMT: The intervention will utilize the POWERbreathe® device. Participants will be provided with the device for home training. The model selected for this study is the POWERbreathe® Classic Medium Resistance (Fitness).

The load will be set at 50% of each participant's MIP, as determined during the assessment phase using a vacuum manometer. IMT will be performed in two sets of 30 breaths through a mouthpiece connected to the POWERbreathe®, with a one-minute rest between sets. Participants will complete the training five days per week at home over the course of eight weeks. Additionally, participants will monitor their adherence by completing a log sheet to mark training days. To ensure proper use and management of the device, each participant will receive individual training after randomization. At the end of the eight weeks, participants will return the equipment to the research team for cleaning and redistribution to another participant in the same group.

干预措施: Group with IMT (Device)

Group without IMT

Placebo Comparator

Group without IMT Participants allocated to the "No IMT Group" will receive the same interventions as the "IMT Group," except for respiratory training. These participants will continue attending CrossFit® training sessions at the gym. They will also perform a simulated IMT, using a device without the valve that generates resistance to the respiratory muscles.

干预措施: CrossFit® Training (Behavioral)

结局指标

主要结局

Effectiveness of TMI on race performance: 25 calorie expenditure on the Air Bike

时间窗: at 8 weeks

Before starting the test, the evaluator will adjust the seat to hip height and ensure that each participant's arms can comfortably reach the handles. The participant must then perform synchronous movements of the upper and lower limbs until reaching the 25-calorie mark

Respiratory muscle strength (Maximum inspiratory pressure (MIP)

时间窗: at 8 weeks and 12 weeks

Respiratory muscle strength (Maximum inspiratory pressure (MIP) Description: The assessment of the strength of the resistant muscles will be performed using a vacuum manometer with an operating range of ± 300 cmH2O. To measure the MIP, the participant must exhale until reaching their Residual Volume (RV), immediately connecting the mouthpiece to the oral tract and making a maximum inspiratory effort against the occluded airway, holding for at least one second.

Respiratory muscle strength (Maximum expiratory pressure (MEP))

时间窗: at 8 and 12 weeks

The assessment of the strength of the resistant muscles will be performed using a manovacuometer with an operating range of ± 300 cmH2O. To measure MEP, the participant must inhale until reaching their Total Lung Capacity and then, inserting the mouthpiece into the oral cavity, perform a maximum expiratory effort against the occluded airway, which must be maintained for at least one second.

次要结局

  • Respiratory muscle strength (Maximum expiratory pressure (MEP))(at 8 and 12 weeks)
  • Subjective perception of effort(at 8 weeks)
  • Respiratory muscle strength (Maximum inspiratory pressure (MIP)(at 8 and 12 weeks)
  • Sit Up(at 8 weeks)
  • 6-minute walk test (6MWT)(at 8 weeks)
  • Box Jump(at 8 weeks)
  • Burpee(at 8 weeks)
  • Pistol(at 8 weeks)
  • Single-Under(at 8 weeks)
  • Thruster(at 8 weeks)
  • Effectiveness of TMI on race performance: 25 calorie expenditure on the Air Bike(at 8 weeks)

研究者

发起方
Federal University of the Valleys of Jequitinhonha and Mucuri
申办方类型
Other
责任方
Sponsor

研究点 (2)

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