UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046453 |
|---|---|
| Receipt number | R000053004 |
| Scientific Title | Alternative index of maximum inspiratory strength in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2021/12/23 |
| Last modified on | 2024/12/25 09:09:34 |
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Basic information
Public title
Alternative index of maximum inspiratory strength in patients with chronic obstructive pulmonary disease
Acronym
Alternative index of maximum inspiratory strength in patients with chronic obstructive pulmonary disease
Scientific Title
Alternative index of maximum inspiratory strength in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Alternative index of maximum inspiratory strength in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to search for alternative indicators of maximum inspiratory strength in patients with chronic obstructive pulmonary disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximum inspiratory pressure
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have been diagnosed with chronic obstructive pulmonary disease
Stable symptoms
Those who are undergoing respiratory rehabilitation
Key exclusion criteria
Those with a history of pneumothorax
Those who have pain in the neck or elbow joint
Those who do not agree to participate in the research
Those who have difficulty understanding the evaluation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Tanaka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, 852-8520 Japan
TEL
+81958197919
tanakataka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Tanaka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, 852-8520 Japan
TEL
+81958197919
Homepage URL
tanakataka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for 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
Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamotomachi, Nagasaki city, Nagasaki
Tel
+81958197919
tanakataka@nagasaki-u.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
田上病院（長崎県）、まさき内科呼吸器クリニック（長崎県）、長生堂渡辺医院（佐賀県）、霧ヶ丘つだ病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 23 | 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
110
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the delay in measurement due to COVID-19, I requested the number of cooperating facilities and extended the period.
Due to take a time to analyze.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
nothing
Outcome measures
1) Basic information: age, gender, height, weight, Body Mass Index (BMI), presence or absence of comorbidity
2) Maximum inspiratory muscle strength
3) Dyspnea (at rest, during exertion)
4) Muscle strength: grip strength, neck flexion, elbow flexion
5) Pulmonary function test
6) Exercise tolerance: 6-minute walking test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
1) Basic information: age, gender, height, weight, Body Mass Index (BMI), presence or absence of comorbidity
2) Maximum inspiratory muscle strength
3) Dyspnea (at rest, during exertion)
4) Muscle strength: grip strength, neck flexion, elbow flexion
5) Pulmonary function test
6) Exercise tolerance: 6-minute walking test
7) Maximum inspiratory flow
8)Short Physical Performance Battery(SPPB)
Management information
Registered date
| 2021 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053004
