UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043099 |
|---|---|
| Receipt number | R000049200 |
| Scientific Title | Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2026/07/28 14:15:09 |
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Basic information
Public title
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Acronym
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Scientific Title
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Scientific Title:Acronym
Effect of inspiratory muscle Training on diaphragm and exercise tolerance in patients with COPD
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of inspiratory muscle training on the diaphragm in patient with COPD .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diaphragmatic excursion
Key secondary outcomes
exercise capacity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Setting Inspiratory Muscle Training for more than 12weeks.
Interventions/Control_2
Do not do inspiratory muscle training
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The participants are clinically stable COPD who visited the Department of Rehabilitation Medicine at kindai University Hospital.
Key exclusion criteria
The exclusion criteria includ unstable medical conditions that cause or contribute to breathlessness (i.e. metabolic, cardiovascular, or other respiratory diseases) or any other disorders that interfere with exercise testing, such as neuromuscular diseases or musculoskeletal problems.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Shiraishi |
Organization
Kindai University Hospital
Division name
Department of Rehabilitation
Zip code
589-8511
Address
377-2 Onohigashi, Osakasayama-city
TEL
072-366-0221
masashi-shiraishi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Shiraishi |
Organization
Kindai University Hospital
Division name
Department of Rehabilitation
Zip code
589-8511
Address
377-2 Onohigashi, Osakasayama-city
TEL
072-366-0221
Homepage URL
masashi-shiraishi@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Hospital
Address
377-2 Onohigashi, Osakasayama-city
Tel
072-366-0221
masashi-shiraishi@med.kindai.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
| 2021 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
https://doi.org/10.1183/23120541.00035-2024
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1183/23120541.00035-2024
Number of participants that the trial has enrolled
38
Results
38 COPD patients were enrolled; after standardised PR, 33 were randomised to IMT (n=17) or control (n=16). 15 (94%) and 14 (88%) completed the 12-week IMT programme. Maximum diaphragmatic excursion (DEmax) increased significantly in the IMT group (50.1 to 60.6 mm, p<0.001), not in controls (47.4 to 46.9 mm, p=0.10). Changes in DEmax and peak oxygen uptake were significantly greater in the IMT group (p<0.01). IMT after standardised PR improved DEmax and exercise tolerance in COPD.
Results date posted
| 2026 | Year | 07 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics were assessed at randomisation, after completion of the standardised pulmonary rehabilitation programme (n=29 analysed; IMT group n=15, control group n=14).
Age: 75 +/- 4 years (IMT group 76 +/- 3, control group 76 +/- 4)
Sex: 28 male/1 female (IMT group 14 male/1 female, control group 14 male/0 female)
Body mass index: 22.7 +/- 2.3 kg/m2
GOLD stage (1/2/3/4): 2/13/12/2
Maximum diaphragmatic excursion (DEmax): 48.8 +/- 8.0 mm
Maximum inspiratory pressure (PImax): 65.1 +/- 21.4 cmH2O (62.9 +/- 18.7% predicted)
6-minute walk distance (6MWD): 437 +/- 91 m (80.7 +/- 18.3% predicted)
COPD assessment test (CAT) score: 10 (IQR 5-11)
FEV1: 1.49 +/- 0.50 L (59.1 +/- 18.3% predicted)
FVC: 3.10 +/- 0.67 L (96.4 +/- 17.5% predicted)
There were no significant differences in any baseline parameters between the IMT and control groups (all p>0.05).
Participant flow
38 patients with stable COPD who visited the Department of Respiratory Medicine and Allergology at Kindai University Hospital between April 2019 and January 2023 and were referred to the pulmonary rehabilitation (PR) unit were registered for this study.
Of these, 5 patients were excluded because they were registered during the COVID-19 pandemic and could not continue rehabilitation. The remaining 33 patients completed the 12-week standardised PR programme and were subsequently randomised to the IMT group (n=17) or control group (n=16).
During the 12-week IMT programme, 2 participants withdrew from the IMT group (1 due to self-interruption and 1 due to worsening dyspnoea from overuse of the IMT device), while 2 patients in the control group experienced acute exacerbations.
Ultimately, 15 patients (94%) in the IMT group and 14 patients (88%) in the control group, 29 in total, completed the 12-week IMT programme and were included in the analysis.
Adverse events
In the IMT group, one participant experienced worsening dyspnoea due to overuse of the inspiratory muscle training (IMT) device and discontinued the study. With appropriate titration and regular guidance from a physiotherapist, IMT could be performed without severe adverse events.
In the control group, two patients experienced acute exacerbations during the 12-week observation period (a direct relationship to study participation was not established).
No other serious adverse events were reported.
Outcome measures
[Primary outcome]
Change in maximum diaphragmatic excursion (DEmax), measured by ultrasonography, from baseline to the end of the 12-week IMT programme.
[Secondary outcomes]
Change in inspiratory capacity during exercise (delta IC) during constant-loading testing, as a surrogate marker of dynamic lung hyperinflation
Peak oxygen uptake (peak VO2) during incremental loading testing
6-minute walk distance (6MWD)
Minute ventilation (VE) and ventilatory equivalent for carbon dioxide (VE/VCO2)
Maximum inspiratory pressure (PImax)
Endurance time during constant-loading testing
Dyspnoea, assessed using the modified Borg scale
COPD assessment test (CAT) score
Breathing pattern indices, including peak tidal volume-to-inspiratory capacity ratio (peak VT/IC), inspiratory duty cycle (ti/ttot), inspiratory tidal volume (VTI) and expiratory tidal volume (VTE)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049200
