UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061243 |
|---|---|
| Receipt number | R000070082 |
| Scientific Title | A Study of Changes in Cough Strength Induced by Inspiratory Muscle Training in Hospitalised Dialysis Patients |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/13 15:43:01 |
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Basic information
Public title
A Study of Changes in Cough Strength Induced by Inspiratory Muscle Training in Hospitalised Dialysis Patients
Acronym
A Study of Changes in Cough Strength Induced by Inspiratory Muscle Training in Hospitalised Dialysis Patients
Scientific Title
A Study of Changes in Cough Strength Induced by Inspiratory Muscle Training in Hospitalised Dialysis Patients
Scientific Title:Acronym
A Study of Changes in Cough Strength Induced by Inspiratory Muscle Training in Hospitalised Dialysis Patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of inspiratory muscle training (IMT) on peak cough flow (PCF) in hospitalised haemodialysis patients, and to determine whether it contributes to improvements in respiratory muscle strength (PImax and PEmax) and cough function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is an analysis of the difference in changes in cough force (PCF) between the IMT intervention group and the sham group in patients with HD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
In this study, the IMT group consists of participants who undergo inspiratory muscle training using the POWERbreathe, a respiratory muscle training device, with the aim of improving inspiratory muscle strength. The resistance pressure is set at 50 of each participantspeak inspiratory oral pressure .The intervention is performed in a seated position leaning against a wall, involving a rapid and forceful single inhalation from the end-expiratory position. Each session consists of 30 repetitions, performed once daily, four days a week. The duration of each session is approximately 15 minutes.The intervention period is 4 weeks, and the intervention is to be carried out continuously throughout the study period. Assessments are to be conducted prior to the intervention , before the start of the first intervention each week, and upon completion of the final intervention.Furthermore, to assess coughing ability, participants are to perform voluntary coughing whilst wearing a face mask, and the peak cough flow is to be measured.
Interventions/Control_2
In this study, the SHAM group serves as the placebo control; although participants use the POWERbreathe device, the intervention is conducted under conditions where no substantial training load is applied. The pressure is set to 10 mmHg, the minimum value for the device.The intervention conditions (posture, procedure, number of repetitions, frequency, and duration) are the same as those for the IMT group, and the exercise is performed by sitting with the back against a wall and inhaling rapidly from the end-expiratory position. One set consists of 30 repetitions, performed once a day, four days a week (on non-dialysis days). The duration of each session is approximately 15 minutes.The intervention period is 4 weeks. As with the IMT group, assessments are conducted prior to the intervention, before the first intervention of each week, and upon completion of the final intervention.As with the IMT group, the assessment will involve measuring PCF using voluntary coughing via a face mask.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing maintenance haemodialysis who are currently admitted to Hidaka Rehabilitation Hospital, Hidaka Medical Corporation
2) Patients who are adults (in principle, aged 18 years or over) at the time of study enrolment
3) Patients who are able to sit independently and who can undergo IMT and respiratory function tests whilst understanding instructions
4) Patients who have been undergoing dialysis for at least three months
5) Patients from whom written informed consent has been obtained regarding participation in the study
Key exclusion criteria
1) Patients in the acute phase of serious heart conditions, such as acute heart failure or acute coronary syndrome
2) Patients with traumatic pneumothorax or rib fractures that have not fully healed
3) Patients with asthma that frequently relapses
4) Patients with injuries such as a perforated eardrum
5) Patients with a marked increase in left ventricular end-diastolic volume and left ventricular end-diastolic pressure
6) Patients with abdominal hernias
7) Patients who have developed pneumonia or an acute respiratory infection within the last four weeks and whose condition is not stable
8) Patients who have difficulty understanding instructions or coughing safely due to severe cognitive impairment or dysphagia
9) Other patients deemed unsuitable for participation in this study by the principal investigator or a co-investigator
[Rationale for Exclusion Criteria]
1) to 7) From a safety perspective, as these patients are considered to be at high risk of deterioration due to the intervention or measurements.
8) As compliance with measurement and intervention procedures is difficult, which may affect data reliability and safety.
9) To rule out the possibility that participation in the study may be detrimental, based on individual medical judgement.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | HITOSHI |
| Middle name | |
| Last name | KUBOTA |
Organization
Hidaka Rehabilitation Hospital
Division name
Plastic Surgery
Zip code
370-2104
Address
2204 Umate, Yoshii-machi, Takasaki City, Gunma Prefecture
TEL
027-388-2005
nikexero@gmail.com
Public contact
Name of contact person
| 1st name | HITOSHI |
| Middle name | |
| Last name | KUBOTA |
Organization
Hidaka Rehabilitation Hospital
Division name
Plastic Surgery
Zip code
370-2104
Address
2204 Umate, Yoshii-machi, Takasaki City, Gunma Prefecture
TEL
027-388-2005
Homepage URL
nikexero@gmail.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital, Faculty of Medicine Secretariat of the Institutional Review Board
Address
3-39-15 Showa-cho, Maebashi City, Gunma Prefecture
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
IRB2025-119
Org. issuing International ID_1
Gunma University Hospital, Faculty of Medicine Secretariat of the Institutional Review Board
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 | 04 | Month | 14 | 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
| 2026 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2029 | 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 | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070082
