Breathing ExercisesNCT06134778
Effect of Inspiratory Muscle Training on Cardiopulmonary Capacity in Wheelchair Rugby Athletes
A study testing Inspiratory Muscle Training in people with Breathing Exercises and Disability Physical, run by Centro Universitário Augusto Motta.
Trial summary
The goal of this clinical trial is to learn about in inspiratory muscle training on cardiorespiratory capacity, pulmonary function, respiratory muscle strength, sports skills, and quality of life of wheelchair rugby athletes. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises, Disability Physical, Athletes
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male gender,
- Age equal to or greater than 18 years,
- Presence of quadriplegia or tetra-equivalence,
- Wheelchair Rugby training time equal to or greater than six months,
- Participation in at least one official competition in the previous year the search.
Who cannot join
- The presence of musculoskeletal injury or pain that could interfere with the performance of movements in the wheelchair,
- Respiratory infections in the three weeks before the evaluations.
About this study
Official title: Effect of Inspiratory Muscle Training on Cardiorespiratory Fitness, Pulmonary Function, Sports Skills, and Quality of Life in Wheelchair Rugby Athletes
The goal of this clinical trial is to learn about in inspiratory muscle training on cardiorespiratory capacity, pulmonary function, respiratory muscle strength, sports skills, and quality of life of wheelchair rugby athletes. The main question[s] it aims to answer are:
- Are the wheelchair rugby athletes show better results in cardiopulmonary assessment tests in safety and effort, in the post- inspiratory muscle training period, when compared to their results in the pre-inspiratory muscle training period?
- Is inspiratory muscle training capable of increasing ventilatory capacity at rest and during exertion?
Read more
Participants will be evaluated through questionnaires, laboratory and field tests, such as:
- Pulmonary function (spirometry),
- Inspiratory muscle strength (manovacuometry),
- Cardiorespiratory capacity under exertion (cardiopulmonary exercise test),
- Wheelchair rugby specific skills (Beck Battery)
- Quality of life (WHOQOL-DIS) .
Read the detailed description
People with physical-motor disabilities, dependent on wheelchairs, have less mobility compared to people without disabilities, which can, in turn, have a direct and negative impact on the aerobic capacity and health of these individuals. Wheelchair Rugby (WCR) practitioners, as well as other sports, seek constant performance improvement, given the need to achieve better results in competitions. There has been an increase in the evaluation of parameters that may be related to better sports performance, as well as interventions that improve such performance. In relation to collective sports, such as WCR, the evaluation of important parameters such as maximum oxygen consumption during effort, maximum heart rate achieved and anaerobic limits, which enable adequate training adjustment, has gained prominence. Different interventions, such as inspiratory muscle training (IMT), aim to improve respiratory capacity and, consequently, cardiopulmonary capacity in savings and maximum effort. Therefore, this is a clinical study, with the objective of verifying the impact of IMT on cardiopulmonary performance, spirometric variables at rest and during effort, performance in field tests (Beck Battery) and quality of life in WCR athletes. Rugby athletes will be recruited in wheelchairs from teams in Rio de Janeiro, to perform two daily sessions of 30 forced inspirations followed by long, but not maximum, expirations, with a load adjusted between 50% and 60% of maximum inspiratory muscle strength, five times a week for six weeks.
- Conditions
- Breathing Exercises, Disability Physical, Athletes
- Being tested
- Inspiratory Muscle Training
- Keywords
- Inspiratory Capacity, Oxygen consumption, Spirometry, Exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Inspiratory muscle training was performed for six weeks. Athletes performed two daily sessions of 30 forced inspirations followed by long but not maximal expirations, with load adjusted between 50% and 60% of maximum inspiratory pressure, five times a week. A specific device was used for this purpose (Classic, Powerbreathe, United Kingdom), with light or medium resistance adjustment, depending on the subject's maximum inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| IMT group | Experimental | Inspiratory muscle training group Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
Using spirometry, in accordance with the recommendations proposed by the American Thoracic Society (Miller et al 2005). The variables considered were: absolute forced vital capacity and % of predicted, absolute forced expiratory volume in the first second and % of predicted, and absolute maximum forced expiratory flow and % of predicted, with measurement unit in liters (l).
Measured: Six weeks
Respiratory muscle strength
Maximum inspiratory (MIP) and maximum expiratory pressures were evaluated using a digital manovacuometer (MVD300, MDI Produtos e Sistemas, Brazil) with measurement unit in CmH2O.
Measured: Six weeks
Cardiorespiratory capacity
Cardiorespiratory fitness was assessed using the cardiopulmonary exercise test (CPET), performed on an upper limb cycle ergometer (Excite; TechnoGym; ITA). For the gas exchange analysis, a metabolic gas analyzer (Medical Graphics; VO2000; USA) was used. The variables peak oxygen consumption (VO2peak) (ml/kg/min), maximum effort time (min) and final load (w) were considered for analysis.
Measured: Six weeks
Secondary outcomes (2)
Wheelchair Rugby specific skills
The specific skills assessments of the WCR were performed through the application of the Beck Battery (Yilla \& Sherril 1998; Gorla et al 2011) composed of the following tests: (i) passing accuracy; (ii) long-distance pass; (iii) ball-handling; (iv) blocking performance and (v) 20m speed.
Measured: Six weeks
Perceived quality of life
For the quality of life assessment, participants completed the Brazilian version of the World Health Organization Quality of Life Questionnaire for People with Disabilities (WHOQOL-DIS) (Bredemeier et al 2014). The options for each item are described on a five-level Likert scale, where participants rate satisfaction from 1 to 5 (5 "totally agree" and 1 "totally disagree"). The results were presented on a scale of 0 to 100 (WHOQOL,1998), scaled in a positive direction. In other words, the higher the score, the greater the interviewee's perception of QoL in each domain (WHOQOL,1998).
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startMay 2015
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134778
- Sponsor's protocol ID
- 40060714.5.0000.5235
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freitas JP, Costa R, Barranco LC, Reis K, Lopes AJ, Mainenti MRM, Dos Santos Vigario P. Effect of inspiratory muscle training on pulmonary function, respiratory muscle strength, aerobic performance, sports skills, and quality of life in wheelchair rugby athletes. J Bodyw Mov Ther. 2024 Oct;40:360-365. doi: 10.1016/j.jbmt.2024.04.049. Epub 2024 Apr 20.
PubMed 39593611
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Cardiorespiratory Fitness, Pulmonary Function, Sports Skills, and Quality of Life in Wheelchair Rugby Athletes
- ClinicalTrials.gov ID
- NCT06134778
- Acronym / sponsor ID
- 40060714.5.0000.5235
- Conditions
- Breathing Exercises, Disability Physical, Athletes
- Keywords
- Inspiratory Capacity, Oxygen consumption, Spirometry, Exercise test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about in inspiratory muscle training on cardiorespiratory capacity, pulmonary function, respiratory muscle strength, sports skills, and quality of life of wheelchair rugby athletes. The main question[s] it aims to answer are:
- Are the wheelchair rugby athletes show better results in cardiopulmonary assessment tests in safety and effort, in the post- inspiratory muscle training period, when compared to their results in the pre-inspiratory muscle training period?
- Is inspiratory muscle training capable of increasing ventilatory capacity at rest and during exertion?
Participants will be evaluated through questionnaires, laboratory and field tests, such as:
- Pulmonary function (spirometry),
- Inspiratory muscle strength (manovacuometry),
- Cardiorespiratory capacity under exertion (cardiopulmonary exercise test),
- Wheelchair rugby specific skills (Beck Battery)
- Quality of life (WHOQOL-DIS) .
Detailed description
People with physical-motor disabilities, dependent on wheelchairs, have less mobility compared to people without disabilities, which can, in turn, have a direct and negative impact on the aerobic capacity and health of these individuals. Wheelchair Rugby (WCR) practitioners, as well as other sports, seek constant performance improvement, given the need to achieve better results in competitions. There has been an increase in the evaluation of parameters that may be related to better sports performance, as well as interventions that improve such performance. In relation to collective sports, such as WCR, the evaluation of important parameters such as maximum oxygen consumption during effort, maximum heart rate achieved and anaerobic limits, which enable adequate training adjustment, has gained prominence. Different interventions, such as inspiratory muscle training (IMT), aim to improve respiratory capacity and, consequently, cardiopulmonary capacity in savings and maximum effort. Therefore, this is a clinical study, with the objective of verifying the impact of IMT on cardiopulmonary performance, spirometric variables at rest and during effort, performance in field tests (Beck Battery) and quality of life in WCR athletes. Rugby athletes will be recruited in wheelchairs from teams in Rio de Janeiro, to perform two daily sessions of 30 forced inspirations followed by long, but not maximum, expirations, with a load adjusted between 50% and 60% of maximum inspiratory muscle strength, five times a week for six weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Other: Inspiratory Muscle TrainingInspiratory muscle training group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male gender,
- Age equal to or greater than 18 years,
- Presence of quadriplegia or tetra-equivalence,
- Wheelchair Rugby training time equal to or greater than six months,
- Participation in at least one official competition in the previous year the search.
Key exclusion criteria (2 listed)
- The presence of musculoskeletal injury or pain that could interfere with the performance of movements in the wheelchair,
- Respiratory infections in the three weeks before the evaluations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory muscle training was performed for six weeks. Athletes performed two daily sessions of 30 forced inspirations followed by long but not maximal expirations, with load adjusted between 50% and 60% of maximum inspiratory pressure, five times a week. A specific device was used for this purpose (Classic, Powerbreathe, United Kingdom), with light or medium resistance adjustment, depending on the subject's maximum inspiratory pressure. | Other | IMT group |
Primary outcome
Pulmonary function
Time frame: Six weeks
Using spirometry, in accordance with the recommendations proposed by the American Thoracic Society (Miller et al 2005). The variables considered were: absolute forced vital capacity and % of predicted, absolute forced expiratory volume in the first second and % of predicted, and absolute maximum forced expiratory flow and % of predicted, with measurement unit in liters (l).
Respiratory muscle strength
Time frame: Six weeks
Maximum inspiratory (MIP) and maximum expiratory pressures were evaluated using a digital manovacuometer (MVD300, MDI Produtos e Sistemas, Brazil) with measurement unit in CmH2O.
Cardiorespiratory capacity
Time frame: Six weeks
Cardiorespiratory fitness was assessed using the cardiopulmonary exercise test (CPET), performed on an upper limb cycle ergometer (Excite; TechnoGym; ITA). For the gas exchange analysis, a metabolic gas analyzer (Medical Graphics; VO2000; USA) was used. The variables peak oxygen consumption (VO2peak) (ml/kg/min), maximum effort time (min) and final load (w) were considered for analysis.
2 secondary outcomes
Wheelchair Rugby specific skills
Time frame: Six weeks
Perceived quality of life
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39593611Freitas JP, Costa R, Barranco LC, Reis K, Lopes AJ, Mainenti MRM, Dos Santos Vigario P. Effect of inspiratory muscle training on pulmonary function, respiratory muscle strength, aerobic performance, sports skills, and quality of life in wheelchair rugby athletes. J Bodyw Mov Ther. 2024 Oct;40:360-365. doi: 10.1016/j.jbmt.2024.04.049. Epub 2024 Apr 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Breathing Exercises and Disability Physical, run by Centro Universitário Augusto Motta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (time frame: Six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.