UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047619 |
|---|---|
| Receipt number | R000053942 |
| Scientific Title | A study of a randomized control trial of the effect of respiratory muscle training on suppressing recurrence of pneumonia in older people |
| Date of disclosure of the study information | 2022/05/02 |
| Last modified on | 2022/10/28 17:29:51 |
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Basic information
Public title
A study of a randomized control trial of the effect of respiratory muscle training on suppressing recurrence of pneumonia in older people
Acronym
A study of a randomized control trial of the effect of respiratory muscle training on suppressing recurrence of pneumonia in older people
Scientific Title
A study of a randomized control trial of the effect of respiratory muscle training on suppressing recurrence of pneumonia in older people
Scientific Title:Acronym
Respiratory muscle training and recurrence of pneumonia in older people
Region
| Japan |
Condition
Condition
Pneumonia in older people
Classification by specialty
| Medicine in general | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We include older pneumonia inpatients aged 70 years and more with a cognitive function test mini mental state examination (MMSE) 10 and more points. All cases will receive standard treatments for pneumonia according to the guidelines. We will divide them into 2 groups, a group with respiratory muscle training + fortification + rehabilitation for 4 weeks (intervention group) and a rehabilitation group (control group). After the intervention, we will observe the recurrence rate of pneumonia during the 1-year follow-up period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the recurrence rate of pneumonia in the intervention and the control group for 1 year after the beginning of the training. We will observe the presence of superiority of the intervention group to the control group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
The intervention group; Respiratory muscle training + fortification + rehabilitation.
The respiratory muscle training machines are set at a resistance value of 50-80% of the maximum respiratory muscle strength. The patients repeat inspiration and expiration 6 times. Patients will train 5-7 sets a day, 3-5 days a week for 4 weeks.
Nutrition is strengthened with supplemental calories and proteins (especially branched chain amino acids) after its evaluation.
Patients will receive a general respiratory rehabilitation.
Interventions/Control_2
control group; rehabilitation
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older pneumonia patients requiring hospitalization aged 70 years and older, regardless of gender.
Patients that can tolerate standard treatments for pneumonia according to the guidelines.
Patients with a cognitive function test MMSE score 10 and higher, who can perform respiratory muscle training.
Key exclusion criteria
Cancer patients managed within the past 5 years, patients with pacemakers (muscle mass and fat mass cannot be measured), postoperative pneumonia, intubated patients, patients with tracheostomy. Patients that are prone to pneumothorax such as severe interstitial pneumonia and chronic obstructive pulmonary disease, patients whose blood pressure rising is danger such as aortic aneurysm and severe heart failure, patients with severe renal failure (before introduction of dialysis), septic patients, patients with tube feeding, gastric fistula, immunodeficiency patients such as taking immunosuppressive agents or dialysis, patients with multiple fractures of ribs, patients with severe dementia and etc.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Tatsuma |
| Middle name | |
| Last name | Okazaki |
Organization
Tohoku University Hospital
Division name
Department of Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177338
tmokazaki0808@gmail.com
Public contact
Name of contact person
| 1st name | Ryuuko |
| Middle name | |
| Last name | Ishimoda |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Physical Medicine and Rehabilitation
Zip code
9808575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177338
Homepage URL
ishimoda@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Kakenhi
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 05 | Month | 02 | 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
| 2022 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | 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
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053942
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| Registered date | File name |
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