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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001753
Receipt No. R000002112
Scientific Title Hydrokinesiotherapy treatment for fibromyalgia
Date of disclosure of the study information 2009/03/04
Last modified on 2009/03/04

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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
Email

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
Email

Sponsor
Institute Unicapital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002112

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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