UMIN-CTR Clinical Trial

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
Last 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
1st 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