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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022353
Receipt No. R000025280
Scientific Title Theraputic effect of aerobic exercise on severe tinnitus patients
Date of disclosure of the study information 2016/05/31
Last modified on 2019/03/19

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Basic information
Public title Theraputic effect of aerobic exercise on severe tinnitus patients
Acronym Theraputic effect of aerobic exercise on tinnitus
Scientific Title Theraputic effect of aerobic exercise on severe tinnitus patients
Scientific Title:Acronym Theraputic effect of aerobic exercise on tinnitus
Region
Japan

Condition
Condition severe tinnitus
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aerobic exercise has been used to treat several disease, although aerobic exercise is not used to treat tinnitus. We identified the decrease of blood flow in the cerebellum of severe tinnitus patients. In this study, we examine the therapeutic effect of aerobic exercise on tinnitus, because it is reported that aerobic exercise increase the blood flow in the cerebellum.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analog scale of loudness (VAS-L)
Key secondary outcomes Subjective loudness (SubL)
Tinnitus measrures (Hearing level: HL)
Pitch match method
Visual analog scale of QOL (VAS-QOL)
SF-36 (Health Related Quality of Life:HRQOL)
Tinnitus handicap inventory (THI)
Brain region related to symptom of tinnitus
Hamilton Rating Scale for Depression (HAM-D)
YG Personality Inventory
State-Trait Anxiety Inventry-Form (STAI)
Beck Depression Inventory (BDI)
Daily activity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A week before the main study, the exercise intensity needed to drive the heart rate (HR) to 70% of the estimated maximum during the plateau phase of the exercise by bicycle ergometer was determined for each subject. At this exercise intensity, the subjects exercise with bicycle ergometer for 30 min in 5 successive days.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1. The loudness of tinnitus evaluated by the hearing level (HL) is between
60 dB and 90 dB (60 dB <= Loudness of tinnitus (dB HL) <= 90 dB).
2. The averaged-hearing threshold of the subject is within 40 dB.
3. Subjects can exercise with bicycle ergometer.
4. Subjects can take medicine including antianxiety, hypnotic, and antidepressant in usual dose.
Key exclusion criteria Exclusion criteria are as follows:
1. pregnant or lactating women
2. mental disability taking psychotropic drug
3. neurosurgery disease
4. cardiovascular disease
5. respiratory disease
6. orthopedic disease in lower limb
7. patients treated for insulin
8. hearing-impaired patients including sudden hearing loss and Meniere&#39;s disease.
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Ueyama
Organization Wakayama Medical University School of Medicine
Division name Department of Anatomy and Cell Biology
Zip code
Address 811-1 Kimiidera Wakayama, Japan
TEL 073-441-0616
Email tueyama@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Ueyama
Organization Wakayama Medical University School of Medicine
Division name Department of Anatomy and Cell Biology
Zip code
Address 811-1 Kimiidera Wakayama, Japan
TEL 073-441-0616
Homepage URL
Email tueyama@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University School of Medicine
Institute
Department

Funding Source
Organization Wakayama Medical University School of Medicine
Organization
Division
Category of Funding Organization Local Government
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
2016 Year 05 Month 31 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 18 Day
Date of IRB
2015 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2020 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
2016 Year 05 Month 19 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025280

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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