UMIN-CTR Clinical Trial

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
Email	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
Email	ishimoda@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053942