UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Pulmonary Rehabilitation in Patients with Interstitial Pneumonia
Acronym	Effects of Pulmonary Rehabilitation in Patients with Interstitial Pneumonia
Scientific Title	Effects of Pulmonary Rehabilitation in Patients with Interstitial Pneumonia
Scientific Title:Acronym	Effects of Pulmonary Rehabilitation in Patients with Interstitial Pneumonia
Region	Japan

Condition
Condition	Interstitial Pneumonia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of Pulmonary Rehabilitation in Patients with Interstitial Pneumonia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6MWT
Key secondary outcomes	quadriceps force, hand grip, SGRQ, CAT

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	PRP consisted of aerobic exercise, upper and lower limb resistance training, breathing exercises (pursed lip breathing, diaphragmatic breathing), trunk-centered stretching, and patient education (disease knowledge, self-management of disease, and how to use oxygen). Aerobic exercise was performed using a treadmill, at 60-80% of the patient's maximum walking speed, for at least 20-30 min. The maximum walking speed was calculated based on the 6MWD at baseline. Weights were used for resistance training of the upper and lower limbs. Each set consisted of 10-15 repetitions, and the volume was gradually increased to 3-5 sets.
Interventions/Control_2	For patients who did not wish to have outpatient PR (control groups), we provided guidance, using a pamphlet, on how to exercise at home, at the initial evaluation.
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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who were diagnosed with IP, were medically stable, and were able to walk independently were included in this study.
Key exclusion criteria	Patients with orthopedic or central nervous system disorders that cause gait disturbance, dementia, and other diseases with poor prognosis (terminal malignant tumors, severe heart failure, etc.). Further, patients who had previously participated in PRP or recently changed medications were excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name yuji Middle name Last name iwanami
Organization	Toho University Omori Medical Center
Division name	6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
Zip code	1438541
Address	6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
TEL	0337624151
Email	yuuji.iwanami@med.toho-u.ac.jp

Public contact
Name of contact person	1st name yuji Middle name Last name iwanami
Organization	Toho University Omori Medical Center
Division name	Department of Rehabilitation Medicine
Zip code	143-8541
Address	6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
TEL	0337624151
Homepage URL
Email	yuuji.iwanami@med.toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical Center
Institute
Department

Funding Source
Organization	Toho University Omori Medical Center
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	Toho University Omori Medical Center
Address	6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
Tel	0337624151
Email	yuuji.iwanami@med.toho-u.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 03 Month 21 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	Open public recruiting
Date of protocol fixation	2021 Year 09 Month 21 Day
Date of IRB	2022 Year 03 Month 08 Day
Anticipated trial start date	2022 Year 03 Month 21 Day
Last follow-up date	2025 Year 09 Month 21 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 03 Month 21 Day
Last modified on	2022 Year 03 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053880