UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001753 |
|---|---|
| Receipt number | R000002112 |
| Scientific Title | Hydrokinesiotherapy treatment for fibromyalgia |
| Date of disclosure of the study information | 2009/03/04 |
| Last modified on | 2009/03/04 08:15:58 |
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Basic information
Public title
Hydrokinesiotherapy treatment for fibromyalgia
Acronym
Hydrokinesiotherapy treatment for fibromyalgia
Scientific Title
Hydrokinesiotherapy treatment for fibromyalgia
Scientific Title:Acronym
Hydrokinesiotherapy treatment for fibromyalgia
Region
| South America |
Condition
Condition
Despite that fibromyalgia possesses an unknown etiology, it presents some signals and symptoms of pain in hypersensitizing regions defined as tender points, sleep disturbances, psychological disturbances such as depression and anxiety. Fibromyalgia occurs mostly in middle ages women, but it can also occur in men and youths.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this work was to investigate a program of treatment for patients with fibromyalgia using a combination of stretching, aerobics and relaxation exercises in a swimming pool.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Improve quality of life, decrease pain and stress.
Key secondary outcomes
Decrease anxiety, increase muscle strength and flexibility.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Fibromyalgic patients participated in this program. They were all evaluated before and after this program by a life quality questionnaire (SF-36) and an analogical measurement scale of pain. They performed 10 sessions of a combination of stretching, aerobics and relaxation exercises in a swimming pool twice a week with duration of 1 hour.
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Medical diagnostic of Fibromyalgia disease, in a hydrotherapy due to fibromyalgia, no other disease associated, female.
Key exclusion criteria
any other disease associated, male.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Edgard Morya |
Organization
Unicapital
Division name
Physicaltherapy
Zip code
Address
Ibipetuba 130. Parque da Mooca.
TEL
55-11-93501957
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Edgard Morya |
Organization
Unicapital
Division name
Physicaltherapy
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Unicapital
Institute
Department
Personal name
Funding Source
Organization
Unicapital
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
Address
Tel
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
| 2009 | Year | 03 | Month | 04 | 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
Completed
Date of protocol fixation
| 2008 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 04 | Day |
Last modified on
| 2009 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002112
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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