UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058233 |
|---|---|
| Receipt number | R000066575 |
| Scientific Title | Effectiveness of self-controlled high-intensity interval training in patients with chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/20 11:10:58 |
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Basic information
Public title
Investigating the effects of self-imposed vigorous exercise training on patients with chronic obstructive pulmonary disease.
Acronym
Effects of vigorous exercise training on patients with chronic obstructive pulmonary disease.
Scientific Title
Effectiveness of self-controlled high-intensity interval training in patients with chronic obstructive pulmonary disease.
Scientific Title:Acronym
Active high-intensity exercise intervention for COPD patients.
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pilot study and a randomized controlled trial will be conducted in patients with stable COPD in the early stages of disease to examine the short- and long-term effects of implementing high-intensity interval training on physical activity, physical characteristics, and psychological aspects of the disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Exercise tolerance, limb muscle strength, respiratory function, body composition, dyspnea, anxiety/depression, motivation to exercise
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
48 weeks of self-management with high-intensity interval training at own body weight.
Interventions/Control_2
Exercise recommendations only.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with stable COPD.
No rehabilitation in the past year.
Key exclusion criteria
FEV1/FVC greater than 70%, mMRC greater than 3, concomitant respiratory disease other than COPD, concomitant cardiac disease, poor nutritional status (BMI < 18.5), gait disturbance due to lower limb orthopedic disease, deemed inappropriate by the physician in charge, inability to operate smart phones or DVD viewing devices.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Shojiro |
| Middle name | |
| Last name | Egoshi |
Organization
Hiroshima Cosmopolitan University
Division name
Faculty of Health Sciences, Department of Rehabilitation, Physical Therapy
Zip code
731-
Address
3-2-1 Ozukahigashi, Asaminami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-849-6883
egoshi@hcu.ac.jp
Public contact
Name of contact person
| 1st name | Shojiro |
| Middle name | |
| Last name | Egoshi |
Organization
Hiroshima Cosmopolitan University
Division name
Faculty of Health Sciences, Department of Rehabilitation, Physical Therapy
Zip code
731-3166
Address
3-2-1 Ozukahigashi, Asaminami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-849-6883
Homepage URL
egoshi@hcu.ac.jp
Sponsor or person
Institute
Hiroshima Cosmopolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Hiroshima Cosmopolitan University Ethics Review Committee
Address
3-2-1 Ozukahigashi, Asaminami-ku, Hiroshima City, Hiroshima Prefecture
Tel
082-849-6883
makitar@hcu.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
| 2025 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | 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
| 2025 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066575
