Respiratory Muscle Strength and Function in Healthy Kids

Respiratory muscle strength training (RMST) is a potential treatment option that has been shown to increase strength and ventilatory function in critically ill patients, patients on ventilators and patients with mild neuromuscular weakness. Currently researchers are examining the role of inspiratory muscle strength training (IMST) in pressure performance of ventilator dependent children with Pompe disease. However, normal pressure-flow-timing responses of lung function are not well-characterized in healthy children. The purpose of this study is to measure RMST-induced changes in respiratory function in healthy children. Children will undergo one session of lung function and strength testing. By studying healthy children's respiratory function, this study will also help to develop more efficient respiratory muscle training exercise prescriptions for children with neuromuscular weakness and impaired respiratory function.

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Key information

Conditions

Respiratory Muscle Strength

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

The goals of this study are to collect and evaluate respiratory muscle strength training (RMST) induced changes in ventilatory function in healthy children. Children will undergo one session of pulmonary function and strength testing to quantify rate of inspiratory and expiratory pressure development and to determine whether inspiratory and expiratory pressure correlate to maximal respiratory pressures and forced pulmonary function tests. Currently normal pressure-flow-timing responses are not well-characterized in healthy children. The purpose of this study is to help develop more efficient RMST exercise prescriptions for ill children on ventilators and with neuromuscular weakness.

Participants in the study will refrain from caffeine products and exercise on the day of respiratory testing. In conjunction with respiratory testing, baseline and exertional blood pressure, heart and respiratory rate, and pulse oximetry will be monitored. Participants will complete tidal flow-volume assessments and forced expiratory maneuvers according to the AMerican Thoracic Society guidelines. Participants will undergo 5 sets of 10 maximal-effort breaths against standardized resistances (one set each at 0, 5, 10, 15, and 20 cm H20). Following each set, subjects will rate the load magnitude and their feelings of breathing discomfort using a 0-10 visual analog scale. Participants will also perform maximal inspiratory and expiratory pressure maneuvers. All tests will be separated by at least 2-3 minutes of rest.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female subjects 4-16 years of age.
Healthy subjects

Exclusion criteria

Have primary pulmonary disease
Have primary neuromuscular disease
Have a connective tissue or autoimmune disease
Have had a respiratory infection with in 15 days prior to study date
Have acute aminoglycosides antibiotic therapy with in 15 days prior to study date
Have acute corticosteroids with in 15 days prior to study date
Have a need to use an inhaler routinely
Have hepatic failure
Have hematologic failure
Have participated in other studies related to medications or exercise
Have used tobacco products
Have other precautions

Treatment and study plan

Primary outcomes

Pulmonary Function Testing

Time frame: Day 1

Subjects will complete tidal flow-volume assessments and forced expiratory maneuvers.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Respiratory Muscle Strength and Function in Healthy Children

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Sep 19, 2011
Registry last updated: Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed