UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039531 |
|---|---|
| Receipt number | R000045050 |
| Scientific Title | Investigation for effects and functional mechanisms of exercise therapy for patients with fibromyalgia |
| Date of disclosure of the study information | 2020/02/19 |
| Last modified on | 2024/09/06 10:53:39 |
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Basic information
Public title
Investigation for effects and functional mechanisms of exercise therapy for patients with fibromyalgia
Acronym
Investigation for effects and functional mechanisms of exercise therapy for patients with fibromyalgia
Scientific Title
Investigation for effects and functional mechanisms of exercise therapy for patients with fibromyalgia
Scientific Title:Acronym
Investigation for effects and functional mechanisms of exercise therapy for patients with fibromyalgia
Region
| Japan |
Condition
Condition
Fibromyalgia
Classification by specialty
| Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to reveal effects and functional mechanisms of exercise therapy for patients with fibromyalgia.
Basic objectives2
Others
Basic objectives -Others
functional mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity (NRS), PDAS, HADS, PSEQ, PCS, JFIQ, EQ-5D, SF-8, Trail Making Test score, functional connectivity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver | Other |
Interventions/Control_1
Exercise therapy including range of motion exercise, strength training, balance training, aerobic exercise
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who meet the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
Key exclusion criteria
People who are not prescribed exercise therapy because of unstable vital signs; who are implanted with non-MRI-compatible materials; who are claustrophobia; who are or may become pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Fujita |
Organization
Naragakuen University
Division name
Facalty of Health Sciences, Department of Rehabilitation
Zip code
651-8524
Address
3-15-1 Nakatomigaoka, Nara, Nara
TEL
0742-93-5428
nobuko-fujita@naragakuen-u.jp
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Fujita |
Organization
Naragakuen University
Division name
Department of Rehabilitation, Facalty of Health Sciences
Zip code
651-8524
Address
3-15-1 Nakatomigaoka, Nara, Nara
TEL
0742-93-5428
Homepage URL
nobuko-fujita@naragakuen-u.jp
Sponsor or person
Institute
Naragakuen University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethcal Committee of Naragakuen University Faculty of Helth Sciences
Address
3-15-1 Nakatomigaoka, Nara, Nara
Tel
0742-93-5431
tuzisita@nara-su.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
早石病院（大阪府）、大阪大学大学院医学系研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
17
Results
Using resting-state fMRI, we investigated the mechanism of effectiveness of the exercise program for patients with fibromyalgia. In 13 patients, the scores on the FM questionnaire and the scales of anxiety and fear significantly decreased after the exercise program, and the improvement in depressive tendencies due to the exercise program was significantly correlated with changes in the strength of functional connectivity between the medial PFC and the right amygdala in the limbic system.
Results date posted
| 2024 | Year | 09 | Month | 06 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045050
