UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061992 |
|---|---|
| Receipt number | R000070940 |
| Scientific Title | A Multicenter Study of Gravity Release Intervention Technique for Improving Exercise Capacity in Patients with Idiopathic Pleuroparenchymal Fibroelastosis (PPFE): The GRIT Study |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/21 22:12:32 |
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Basic information
Public title
Multicenter Study on the Effects of Body Position on Exercise Capacity in Patients with Idiopathic Pleuroparenchymal Fibroelastosis (PPFE)
Acronym
GRIT Study
Scientific Title
A Multicenter Study of Gravity Release Intervention Technique for Improving Exercise Capacity in Patients with Idiopathic Pleuroparenchymal Fibroelastosis (PPFE): The GRIT Study
Scientific Title:Acronym
GRIT Study
Region
| Japan |
Condition
Condition
Idiopathic Pleuroparenchymal Fibroelastosis (PPFE)
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to determine the differences in exercise capacity and ventilatory efficiency between sitting and supine positions in patients with idiopathic pleuroparenchymal fibroelastosis (PPFE). In addition, this study aims to evaluate the effectiveness of the Gravity Release Intervention Technique (GRIT) and to identify factors associated with its therapeutic effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in exercise endurance time between sitting-cycle ergometer testing and supine-cycle ergometer testing in patients with idiopathic pleuroparenchymal fibroelastosis (PPFE)
Key secondary outcomes
1.Factors associated with the difference in exercise endurance time between sitting and supine positions in patients with PPFE.
2.Differences in ventilatory efficiency between sitting and supine positions and factors associated with these differences in patients with PPFE.
3.Comparisons of exercise endurance time, ventilatory efficiency, and diaphragmatic excursion among patients with PPFE, COPD, IPF, and healthy controls.
4.Changes in 6-minute walk distance, exercise endurance time, and ventilatory efficiency after pulmonary rehabilitation and factors associated with these changes.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with idiopathic pleuroparenchymal fibroelastosis (iPPFE), chronic obstructive pulmonary disease (COPD), or idiopathic pulmonary fibrosis (IPF), whose clinical condition has been stable for at least 4 weeks, or healthy adults.
2.Patients with a modified Medical Research Council (mMRC) dyspnea score >1.
3.Written informed consent obtained prior to participation.
Key exclusion criteria
1.Pneumothorax within 3 months before enrollment.
2.Receiving long term oxygen therapy.
3.Musculoskeletal disorders affecting upper or lower limb muscle strength.
4.Connective tissue diseases interfering with physical function assessment.
5.Cerebrovascular disease with clinically significant neurological deficits.
6.6. Ongoing pulmonary rehabilitation at enrollment (completion at least 6 months before enrollment is allowed).
7.Any condition judged by the investigator to make participation inappropriate.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Matsumoto |
Organization
Kindai University Faculty of Medicine
Division name
Department of Respiratory Medicine and Allergology
Zip code
590-0197
Address
1-14-1 Mihara-dai, Minami-ku, Sakai, Osaka 590-0197, Japan
TEL
072-288-7222
hmatsumoto@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Shiraishi |
Organization
Kindai University Hospital
Division name
Department of Rehabilitation
Zip code
590-0197
Address
1-14-1 Mihara-dai, Minami-ku, Sakai, Osaka 590-0197, Japan
TEL
072-288-7222
Homepage URL
masashi-shiraishi@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Masashi Shiraishi
Funding Source
Organization
Department of Respiratory Medicine and Allergology, Kindai University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine Ethics Committee
Address
1-14-1 Mihara-dai, Minami-ku, Sakai, Osaka 590-0197, Japan
Tel
072-288-7222
zizen@med.kindai.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
Osaka
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | 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
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter interventional study. The primary target population is patients with idiopathic pleuroparenchymal fibroelastosis (PPFE). Exercise capacity and ventilatory efficiency will be compared between sitting and supine positions. In addition, the effectiveness of pulmonary rehabilitation using the Gravity Release Intervention Technique (GRIT) will be evaluated. Patients with COPD, patients with IPF, and healthy adults will be enrolled as comparison groups.
Management information
Registered date
| 2026 | Year | 06 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070940
