Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062421) titled 'Effects of maximum insufflation training on respiratory function' on July 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Japan University of Health Sciences
Condition:
Condition - Neuromuscular diseases (including amyotrophic lateral sclerosis [ALS])
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the effects of lung insufflation capacity (LIC) training and maximum insufflation capacity (MIC) training as lung volume recruitment (LVR) techniques on respiratory function and perceived difficulty in healthy male adults, and to obtain preliminary evidence for future studies in patients with neuromuscular diseases.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Lung insufflation capacity (LIC) training was performed as a lung volume recruitment (LVR) technique using the LIC TRAINER equipped with a one-way valve. The intervention was performed in the supine position with a pillow and the lower limbs extended, once weekly for 4 weeks. Each session consisted of three maximal insufflations with a 5-second breath hold, with adequate rest between repetitions. All interventions were administered by the principal investigator.
Interventions/Control_2 - Maximum insufflation capacity (MIC) training was performed using a bag-valve mask. The intervention was performed in the supine position with a pillow and the lower limbs extended, once weekly for 4 weeks. Each session consisted of three maximal insufflations with a 5-second breath hold, with adequate rest between repetitions. All interventions were administered by the principal investigator.
Eligibility:
Age-lower limit - 19
years-old
=
Gender - Male
Key inclusion criteria - Healthy male students enrolled in the Department of Physical Therapy, Osaka University of Human Sciences, who provided written informed consent to participate in the study.
Key exclusion criteria - Individuals with a history of respiratory diseases, including spontaneous pneumothorax or asthma, and students enrolled in the seminar supervised by the principal investigator.
Target Size - 10
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2018 Year 09 Month 28 Day
Date of IRB - 2018 Year 09 Month 28 Day
Anticipated trial start date - 2019 Year 07 Month 04 Day
Last follow-up date - 2019 Year 12 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071389
Disclaimer: Curated by HT Syndication.