UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047241 |
|---|---|
| Receipt number | R000053880 |
| Scientific Title | Effects of Pulmonary Rehabilitation in Patients with Interstitial Pneumonia |
| Date of disclosure of the study information | 2022/03/21 |
| Last modified on | 2022/03/21 20:18:51 |
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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
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
yuuji.iwanami@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053880
