UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022353 |
|---|---|
| Receipt number | 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 16:59:45 |
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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'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
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
tueyama@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025280
