Respiratory Muscle Strength and Function in Healthy Kids

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01436318
First received: September 16, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition
Respiratory Muscle Strength

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Respiratory Muscle Strength and Function in Healthy Children

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Pulmonary Function Testing [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Subjects will complete tidal flow-volume assessments and forced expiratory maneuvers.


Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Respiratory Function
Children will undergo one session of pulmonary function and strength testing

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy Children

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436318

Contacts
Contact: Donna Johns (352) 392-7861 donnajohns@ufl.edu
Contact: Lee Ann Lawson, ARNP (352) 575-0852 llawson@pedcard.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Barb K Smith, PT, PhD    352-294-5315    bksmith@phhp.ufl.edu   
Contact: Donna Johns    (352) 392-7861    donnajohns@ufl.edu   
Principal Investigator: Barbara K Smith, PT, PhD         
Sub-Investigator: Barry J Byrne, MD, PhD         
Sub-Investigator: Lee Ann Lawson, ARNP         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Barbara K Smith, PT, PhD University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01436318     History of Changes
Other Study ID Numbers: HK 176-2011
Study First Received: September 16, 2011
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Healthy Kids
Respiratory
Volunteers

ClinicalTrials.gov processed this record on July 26, 2014