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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011736
Receipt No. R000013510
Scientific Title Respiratory muscle fatigue following an aquatic treadmill walking: a randomized, cross-over trial
Date of disclosure of the study information 2013/09/17
Last modified on 2016/04/08

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Basic information
Public title Respiratory muscle fatigue following an aquatic treadmill walking: a randomized, cross-over trial
Acronym Respiratory muscle fatigue following an aquatic treadmill walking: a randomized, cross-over trial
Scientific Title Respiratory muscle fatigue following an aquatic treadmill walking: a randomized, cross-over trial
Scientific Title:Acronym Respiratory muscle fatigue following an aquatic treadmill walking: a randomized, cross-over trial
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Pneumology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of subaerial versus aquatic treadmill walking with equal exercise intensity on the respiratory muscle fatigue, and whether swimming could potentiate respiratory muscle strength and endurance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximal inspiratory and expiratory mouth pressure at functional residual capacity
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 aquatic treamill walking
Interventions/Control_2 subaerial treadmill walking
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
25 years-old >=
Gender Male
Key inclusion criteria Male student volunteers among the swimming club or other sports club with informed, written concent for participation
Key exclusion criteria Volunteers who have smoking habit, respiratory disease, ischemic heart disease, chronic heart failure, hypertension(blood pressure is 140/90mmHg or more), or diabetes

Volunteers who are judged inappropriate for participation to the trial by the physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisayo Yokoyama
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code
Address 3-3-138, Sugimoto, Sumiyoshi-ku, Osaka, Osaka
TEL 06-6605-2947
Email yokoyama@sports.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisayo Yokoyama
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code
Address 3-3-138, Sugimoto, Sumiyoshi-ku, Osaka, Osaka
TEL 06-6605-2947
Homepage URL
Email yokoyama@sports.osaka-cu.ac.jp

Sponsor
Institute Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
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
2013 Year 09 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2013 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 12 Day
Last modified on
2016 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013510


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