Unique ID issued by UMIN | UMIN000039893 |
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Receipt number | R000045500 |
Scientific Title | The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease |
Date of disclosure of the study information | 2020/03/22 |
Last modified on | 2020/03/22 23:26:57 |
The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease
The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease
The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease
The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease
Japan |
outpatients with chronic obstructive pulmonary disease
Pneumology | Rehabilitation medicine |
Others
NO
To investigate the effect of inspiratory muscle training on exercise capacity and physical activity in patients with chronic obstructive pulmonary disease
Efficacy
1) physical activity
1) 6-minutes walking test
2) maximum inspiratory mouth pressure (PImax)
3) COPD assessment test (CAT)
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
YES
Institution is considered as a block.
YES
Pseudo-randomization
2
Treatment
Device,equipment |
The pulmonary rehabilitation added inspiratory muscle training.
Inspiratory muscle training: 30-50% of PImax intensity, 30 breaths per session, 2 session per day, everyday during 3 months.
The pulmonary rehabilitation added inspiratory muscle training.
Inspiratory muscle training: less than 10% of PImax intensity, 30 breaths per session, 2 session per day, everyday during 3 months.
20 | years-old | <= |
Not applicable |
Male
1) The patients are in a stable condition with no exacerbation of COPD for at least the previous 3 months
2) The patients is able to operate the inspiratory muscle trainer and activity monitor
3) The patients is able to walk without assist and be independent in daily life
4) The patients do not experiment inspiratory muscle training at least the previous 1 year
the patients have no severe and/or unstable cardiac disease, orthopedic disease or mental disorder.
100
1st name | Takanobu |
Middle name | |
Last name | Shioya |
Akita University Graduate School of Health Sciences
Department of Physical Therapy
010-8543
1-1-1, Hondo, Akita
018-884-1111
shioya@hos.akita-u.ac.jp
1st name | Kazuki |
Middle name | |
Last name | Okura |
Akita University Hospital
Division of Rehabilitation
010-8543
44-2, Hasunuma, Aza, Hiroomote, Akita
0188846372
okura@hos.akita-u.ac.jp
Akita University Graduate School of Health Sciences
Self funding
Self funding
the medical ethics committee of Akita University School of Medicine
1-1-1, Hondo, Akita
018-884-6028
soken@hos.akita-u.ac.jp
NO
市立秋田総合病院(秋田県)、海南病院(愛知県)、公立陶生病院(愛知県)、坂出市立病院(香川県)、江南病院(熊本県)、要町病院(東京都)、KKR高松病院(香川県)
2020 | Year | 03 | Month | 22 | Day |
Unpublished
59
In primary outcome, a significant interaction was observed in the number of steps. In addition, there was a significant within-group difference only in the IMT group. In addition, MVPA also had a significant interaction. In addition, there was a significant within-group difference only in the IMT group.
In secondary outcome, PImax showed a significant interaction. In addition, there was a significant within-group difference only in the IMT group. There was no significant interaction with 6MWD and CAT.
2020 | Year | 03 | Month | 21 | Day |
Delay expected |
Delayed analysis and article writing
Eligibility was assessed on 87 patients.
Consent was obtained from 59 patients during the recruitment period.
Four of them were excluded because even if the load on the inspiratory muscle trainer was minimized, the strength of the control group (less than 10% PImax) could not be satisfied.
55 patients were assigned to 27 in the intervention group and 28 in the control group.
In the intervention group, 3 patients dropped out due to acute exacerbation, acute orthopedic disease, and refusal to continue the intervention.
In the control group, one patient dropped out due to acute exacerbation.
Due to measurement deficiencies in one of the intervention groups, the analysis included 23 intervention groups and 27 control groups.
None
Completed
2016 | Year | 08 | Month | 01 | Day |
2016 | Year | 08 | Month | 29 | Day |
2016 | Year | 11 | Month | 01 | Day |
2018 | Year | 01 | Month | 31 | Day |
2020 | Year | 03 | Month | 21 | Day |
2020 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045500
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