NCT06134778

Brief 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. 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) .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

October 26, 2023

Last Update Submit

November 13, 2023

Conditions

Keywords

Inspiratory CapacityOxygen consumptionSpirometryExercise test

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    Six weeks

Secondary Outcomes (2)

  • Wheelchair Rugby specific skills

    Six weeks

  • Perceived quality of life

    Six weeks

Other Outcomes (3)

  • Sports training

    Six weeks

  • Total body mass

    Six weeks

  • Height

    Six weeks

Study Arms (1)

IMT group

EXPERIMENTAL

Inspiratory muscle training group

Other: Inspiratory Muscle Training

Interventions

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.

IMT group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 18, 2023

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

November 18, 2023

Record last verified: 2023-11