UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062438 |
|---|---|
| Receipt number | R000071457 |
| Scientific Title | A Randomized Feasibility Trial of Inspiratory Muscle Training Combined with Oral Nutritional Supplementation in Patients with Chronic Obstructive Pulmonary Disease |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/02 14:14:34 |
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Basic information
Public title
Effects of Inspiratory Muscle Training Combined with Nutritional Intervention in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Feasibility Trial
Acronym
Inspiratory Muscle Training and Nutrition COPD Trial
Scientific Title
A Randomized Feasibility Trial of Inspiratory Muscle Training Combined with Oral Nutritional Supplementation in Patients with Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym
Inspiratory Muscle Training and Nutrition COPD Feasibility Trial
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the preliminary effects of inspiratory muscle training (IMT) alone and IMT combined with oral nutritional supplementation (ONS) on respiratory muscle strength and respiratory muscle mass in patients with chronic obstructive pulmonary disease (COPD).
Basic objectives2
Others
Basic objectives -Others
Assessment of feasibility and preliminary efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory muscle strength: At 6 weeks after study initiation
Key secondary outcomes
Respiratory muscle mass, Dyspnea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Inspiratory muscle training (30 breaths per session, twice daily for 6 weeks) combined with oral nutritional supplementation (one serving of Rehab Time Jelly once daily after inspiratory muscle training for 6 weeks)
Interventions/Control_2
Inspiratory muscle training (30 breaths per session, twice daily for 6 weeks).
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) receiving outpatient pulmonary rehabilitation at participating institutions.
Clinically stable under standard medical treatment.
Able and willing to provide written informed consent.
Key exclusion criteria
1.Patients unable to assume the supine position for diaphragmatic ultrasonography or with comorbid conditions affecting diaphragmatic movement.
2.Patients who experienced an acute exacerbation within 4 weeks prior to enrollment.
3.Patients judged by the attending physician to be unable or unsuitable to perform inspiratory muscle training (IMT).
4.Patients unable to consume oral nutritional supplements because of allergy or dysphagia.
5.Patients whose clinical condition is expected to change during the study period, making study participation difficult.
6.Patients who had been performing inspiratory muscle training before study enrollment.
7.Patients considered unsuitable for participation by the attending physician or the principal investigator.
Target sample size
30
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
Zip code
8528520
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
0958197919
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
Zip code
8528520
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
0958197919
Homepage URL
takako_t4543@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Takako Tanaka
Funding Source
Organization
Japan Science and Technology Agency (JST)
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 Health Sciences Ethics Committee, Nagasaki University Graduate School of Biomedical Sciences,
Address
1-7-1 sakamoto, Nagasaki, Japan
Tel
0958197919
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 08 | Month | 02 | Day |
Last modified on
| 2026 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071457
