UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051208 |
|---|---|
| Receipt number | R000058338 |
| Scientific Title | The Effects of Yoga on Coughing: A Randomized Crossover Study |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2025/06/01 09:07:00 |
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Basic information
Public title
The Effects of Yoga on Coughing: A Randomized Crossover Study
Acronym
The Effects of Yoga on Coughing: A Randomized Crossover Study
Scientific Title
The Effects of Yoga on Coughing: A Randomized Crossover Study
Scientific Title:Acronym
The Effects of Yoga on Coughing: A Randomized Crossover Study
Region
| Japan |
Condition
Condition
chronic cough
Classification by specialty
| Pneumology | Geriatrics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether yoga affects the cough reflex and whether it is related to pain threshold and dyspnea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of the cough reflex before and after the yoga intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention: A maximum of 60-minute yoga program (consisting of several yoga postures and breathing exercises) will be performed following the face-to-face guidance by a yoga instructor.
Interventions/Control_2
Control: No yoga program is performed, with a maximum of 60 minutes rest.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Healthy adult men and women between the ages of 18 and 65 (at the time of enrollment)
- Persons who do not regularly practice yoga
- Persons who have given their written consent to participate in the study
Key exclusion criteria
Patients with diseases that may affect respiratory function and physical activity: respiratory disease, gastroesophageal reflux disease, upper respiratory tract inflammation, angiotensin-converting enzyme inhibitors (ACE inhibitors), morphine or over-the-counter cough medicines, vocal nodules, malignant tumor, renal dysfunction, liver disease, hypertension (160/100 mmHg or higher), cerebrovascular disease, skeletal muscle disorder, orthopedic disease, chronic pain, women who are pregnant, may be pregnant, have cognitive impairment or mental dysfunction, current smokers, and those who have any of the following Current smokers, women who are pregnant, may become pregnant, or within 28 days postpartum, current smokers, those with cognitive or mental dysfunction, those who refused to participate in this study, and those who were deemed inappropriate by the physician to participate in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University
Division name
Department of Internal Medicine and Rehabilitation Science, Graduate School of Medicine
Zip code
980-0872
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-727-7353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | Miura |
Organization
Tohoku University
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-0872
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-727-7353
Homepage URL
hisakomiura@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 05 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058338
