- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06134778
Effect of Inspiratory Muscle Training on Cardiopulmonary Capacity in Wheelchair Rugby Athletes
November 13, 2023 updated by: Centro Universitário Augusto Motta
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?
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) .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IMT group
Inspiratory muscle training group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Six weeks
|
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.
|
Six weeks
|
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.
|
Six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wheelchair Rugby specific skills
Time Frame: Six weeks
|
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.
|
Six weeks
|
Perceived quality of life
Time Frame: Six weeks
|
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).
|
Six weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sports training
Time Frame: Six weeks
|
For the characterization of the study participants regarding injury and sports training, a questionnaire adapted from Gomes (2014) was applied, with questions related to WCR practice time, training routine, participation in competitions, functional classification, in addition to information about the type, level and time of injury.
|
Six weeks
|
Total body mass
Time Frame: Six weeks
|
The measurement of total body mass (TBM) was carried out with the participant in his wheelchair, using a scale of adequate dimensions, with an accuracy of 0.1 kg (ID-M300/5, Filizola, Brazil) and measurement unit in kilogram (kg).
To determine the final TBM, the weight of the wheelchair was discounted.
|
Six weeks
|
Height
Time Frame: Six weeks
|
Height was measured with the participant in the supine position on a stretcher (tape measure with 0.1 cm precision; CESCORF, Rio Grande do Sul, Brazil) and measurement unit in centimeters (cm).
The measurement of supine height was considered the distance between the plane of the vertex and the sole of the feet (Guedes & Guedes 2006).
|
Six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
October 26, 2023
First Submitted That Met QC Criteria
November 13, 2023
First Posted (Estimated)
November 16, 2023
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40060714.5.0000.5235
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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