UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054042 |
|---|---|
| Receipt number | R000061700 |
| Scientific Title | Effects of acute exercise on cardiorespiratory function in patients with obstructive sleep apnea syndrome. |
| Date of disclosure of the study information | 2024/04/03 |
| Last modified on | 2024/04/02 21:55:41 |
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Basic information
Public title
Effects of acute exercise on cardiovascular and respiratory function in patients with obstructive sleep apnea syndrome.
Acronym
Effects of acute exercise on cardiorespiratory function in patients with obstructive sleep apnea syndrome.
Scientific Title
Effects of acute exercise on cardiorespiratory function in patients with obstructive sleep apnea syndrome.
Scientific Title:Acronym
Effects of acute exercise on cardiorespiratory function in patients with obstructive sleep apnea syndrome.
Region
| Japan |
Condition
Condition
Obstructive sleep apnea syndrome
Healthy adults
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effects of acute inspiratory muscle exercise on the cardiorespiratory response during exercise and on post-exercise vascular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow-mediated dilation
Key secondary outcomes
Maximum inspiratory mouth pressure
Maximum expiratory mouth pressure
Forced vital capacity
Forced expiratory volume in 1 second
Cerebrovascular CO2 reactivity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Inspiratory muscle exercise
Inspiratory muscle loading device
Target intensity: 70-75% of maximal inspiratory mouth pressure
Frequency and time: 5 sets of 6 breaths with 2 min set rest, a total of 10.5 min
Inspiration and expiration durations during exercise: 2 sec and 3 sec
Interventions/Control_2
Inspiratory muscle exercise
Inspiratory muscle loading device
Target intensity: 10-15% of maximal inspiratory mouth pressure
Frequency and time: 5 sets of 6 breaths with 2 min set rest, a total of 10.5 min
Inspiration and expiration durations during exercise: 2 sec and 3 sec
To perform only healthy adults
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 40-80 with a diagnosis of obstructive sleep apnea
Healthy men and women aged 40-80 years without a diagnosis of obstructive sleep apnea
Key exclusion criteria
Currently have or are being treated for any of the following
Chronic heart failure, asthma, restricting and obstructive ventilation disorders, central and peripheral nervous system disorders, diabetes mellitus (HbA1c > 7%),
hypothyroidism, immunodeficiency disorders
Head, neck, or chest surgery within the past 3 years
Body Mass Index (BMI) greater than 40 or less than 18.5
Apnea Hypopnea Index (AHI) greater than 15 during treatment within the past year
Mixed (obstructive and central) sleep apnea
Resting blood pressure greater than 160/100 mmHg or less than 100/60 mmHg
Exercise at least 5 times a week at a moderate intensity or higher
Current smokers,
<Healthy adults> Subjects who have smoked within the past 5 years.
<Women> Currently undergoing hormone therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Iwamoto |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Science
Zip code
060-8556
Address
17 Chome Minami 1 Jo Nishi
TEL
011-611-2111
e.iwamoto@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Iwamoto |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Science
Zip code
060-8556
Address
17 Chome Minami 1 Jo Nishi
TEL
011-611-2111
Homepage URL
e.iwamoto@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Ethics Committee
Address
17 Chome Minami 1 Jo Nishi
Tel
011-611-2111
rinri@sapmed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061700
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| Registered date | File name |
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