- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807957
Inspiratory Muscle Training in Amateur CrossFit® Athletes
Effectiveness of Inspiratory Muscle Training on Respiratory Muscle Strength and Physical Performance in Amateur CrossFit® Athletes: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diego M Xavier, PhD student
- Phone Number: +55 31 997106999
- Email: diegomendesxav@gmail.com
Study Contact Backup
- Name: Murilo X Oliveira, Pdh
- Phone Number: +55 38 9996-0002
- Email: murilo.xavier@ufvjm.edu.br
Study Locations
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-
Minas Gerais
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Sete Lagoas, Minas Gerais, Brazil, 35700-007
- Recruiting
- Academia Compasso - Kapura
-
Contact:
- Mariana P Oliveira, Phd
- Phone Number: +55 31 8585-8588
- Email: maripaulinoliveira@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 60 years;
- Be enrolled in a CrossFit® program;
- Be available to perform TMI at home 5 days a week.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group with IMT
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. |
Group with IMT + CrossFit training
The training routine will occur seven days a week, with participants encouraged and motivated to attend at least five training sessions.
CrossFit® classes will include: warm-up exercises, strength training (with a focus on Olympic weightlifting and free weights), strength endurance (body weight and external loads), aerobic capacity (across multiple domains), maximal aerobic power (across multiple domains), anaerobic capacity (across multiple domains), cool-down activities, and mobility exercises.
Each training session will be designed and supervised by a team of certified physical educators.
|
|
Placebo Comparator: Group without IMT
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.
|
The training routine will occur seven days a week, with participants encouraged and motivated to attend at least five training sessions.
CrossFit® classes will include: warm-up exercises, strength training (with a focus on Olympic weightlifting and free weights), strength endurance (body weight and external loads), aerobic capacity (across multiple domains), maximal aerobic power (across multiple domains), anaerobic capacity (across multiple domains), cool-down activities, and mobility exercises.
Each training session will be designed and supervised by a team of certified physical educators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory muscle strength (Maximum expiratory pressure (MEP))
Time Frame: 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.
|
at 8 and 12 weeks
|
|
Respiratory muscle strength (Maximum inspiratory pressure (MIP)
Time Frame: 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.
|
at 8 weeks and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of TMI on race performance: 25 calorie expenditure on the Air Bike
Time Frame: 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
|
at 8 weeks
|
|
Subjective perception of effort
Time Frame: at 8 weeks
|
At the end of the exercises on the second day of evaluation, study participants must respond/quantify their perception of effort after training - using the Borg's Perceived Exertion Scale (Scale Borg / 6 - 20).
The higher the score, the greater the feeling of effort
|
at 8 weeks
|
|
6-minute walk test (6MWT)
Time Frame: at 8 weeks
|
The 6MWT is a commonly used test for objective assessment of functional exercise capacity.
In this relatively low complexity test, the patient is asked to walk as far as possible along a 30 m corridor for a period of 6 minutes, with the primary outcome being the walking distance during the 6 minutes
|
at 8 weeks
|
|
Box Jump
Time Frame: at 8 weeks
|
Standardization of 60 repetitions with timed timing.
Height for male population: 60 centimeters (cm); Height for female population: 50 cm
|
at 8 weeks
|
|
Sit Up
Time Frame: at 8 weeks
|
Maximum repetitions in a 2-minute period.
In the starting position, the participant will have their back straight and lying on the floor.
The hands should be touching the floor behind the head and the legs should be in the "Butterfly" position.
The participant should raise the torso, flexing the spine, lifting the shoulders off the floor, until the hands touch the floor with the feet.
Then, the upper part of the body should return to the starting position.
The participant should perform as many movements as possible within a time of 2 minutes, with the number of repetitions recorded.
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at 8 weeks
|
|
Burpee
Time Frame: at 8 weeks
|
Maximum repetitions in a 2-minute period.
Initially, the participant will be in an upright position, then he/she must perform a squat with his/her hands on the floor.
After that, he/she must extend his/her elbows and push his/her legs back, keeping his/her hands in the same place, to get into a plank position.
Then, a full push-up must be performed.
With another small jump, the participant must return to the position of step 2, with his/her hands and feet on the floor.
Finally, use all his/her strength and momentum to perform a vertical jump.
The participant must perform as many repetitions as possible in a maximum period of 2 minutes, with the number of repetitions recorded
|
at 8 weeks
|
|
Pistol
Time Frame: at 8 weeks
|
Maximum repetitions in a 2-minute period.
The participant must perform as many repetitions of the movement as possible with the right and/or left leg in a maximum of 2 minutes.
Standing with arms extended forward, the participant must extend one leg forward.
The leg that will remain in support will perform the squat movement, keeping the other leg always extended.
The abdomen must remain contracted and the leg extended throughout the squat movement.
The torso must lean forward, while the hips are positioned backward.
The knee must always be forward, in the direction of the toes.
After the squat, return to the starting position.
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at 8 weeks
|
|
Single-Under
Time Frame: at 8 weeks
|
Standardization of 200 jumps with timed timing.
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at 8 weeks
|
|
Thruster
Time Frame: at 8 weeks
|
20 repetitions with timed exercise.
Men's load: 95lb - 25lb on each side; Women's load: 65lb - 15lb on each side
|
at 8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81443024.9.0000.5108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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