Effects of a Home-Based Inspiratory Muscle Training on Pulmonary Function and Respiratory Muscle Function in Children and Adolescents with Obstructive Sleep Apnea and Obesity: A Pilot Study

• Register: TCTR
• Last refreshed on: 21 June 2021
• Main ID: TCTR20210611007
• Date of registration: 11/06/2021
• Prospective Registration: No
• Primary sponsor: Faculty of Associated Medical Sciences, Chiang Mai University
• Public title: Effects of a Home-Based Inspiratory Muscle Training on Pulmonary Function and Respiratory Muscle Function in Children and Adolescents with Obstructive Sleep Apnea and Obesity: A Pilot Study
• Scientific title: Effects of a Home-Based Inspiratory Muscle Training on Pulmonary Function and Respiratory Muscle Function in Children and Adolescents with Obstructive Sleep Apnea and Obesity: A Pilot Study
• Date of first enrolment: 21/08/2020
• Target sample size: 20
• Recruitment status: Enrolling by invitation
• URL: www.thaiclinicaltrials.org/show/TCTR20210611007
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 1/Phase 2

Countries of recruitment

Thailand

Contacts

• Name: Sainatee Pratanaphon
• Affiliation: Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University

• Name: Sainatee Pratanaphon
• Affiliation: Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Children and adolescents at snoring clinic
2. Obstructive sleep apnea diagnosed by polysomnography (AHI > 1 events/hour) and doctor
3. Individuals classified as obese based on International Obesity Task Force (IOTF) criteria
Exclusion criteria: 1. Abnormal chest shape (e.g., funnel chest, pigeon chest)
2. Craniofacial syndrome
3. Have underlying disease effect on pulmonary function , respiratory muscle function and inspiratory muscle training (e.g., sinusitis, respiratory tract infection, spinal cord injury, rib fracture, pneumonia, spontaneous/traumatic pneumothorax, ruptured eardrum/condition of the ear)
4. Receive pharmacological treatment that effect to decrease respiratory muscle function

Age minimum: 8 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

inspiratory muscle training, obstructive sleep apnea, obesity, children and adolescents

Pulmonary function and respiratory muscle function in children and adolescents with obstructive sleep apnea and obesity
inspiratory muscle training, obstructive sleep apnea, obesity, children and adolescents

Intervention(s)

Active Comparator Device,Sham Comparator Device

inspiratory muscle training (IMT) was performed using the POWERbreathe Classic light device. Protocol for the IMT group consisted of 6 weeks of home-based training with moderate resistance (60-70% of MIP), 3 days a week, once a day.,inspiratory muscle training (IMT) was performed using the POWERbreathe Classic light device. Protocol for the sham group consisted of 6 weeks of home-based training with non-therapeutic resistance (10% of MIP), 3 days a week, once a day.

inspiratory muscle training (IMT) with resistance 60-70% of MIP,inspiratory muscle training (IMT) with resistance 10% of MIP

Primary Outcome(s)

pulmonary function variables before, after 3 week and after 6 week of the intervention pulmonary function test,inspiratory muscle strength before, after 3 week and after 6 week of the intervention maximal inspiratory pressure (MIP)

Secondary Outcome(s)

respiratory muscle endurance before, after 3 week and after 6 week of the intervention maximal voluntary ventilation (MVV)

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

Faculty of Associated Medical Sciences, Chiang Mai University

Ethics review

Status: Submitted, pending
Approval date:
Contact:

[e-mail]

[e-mail]

053936026 Ext.

[e-mail]

Results

• Date Completed: 31/07/2021