UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011736 |
|---|---|
| Receipt number | 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 11:15:33 |
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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
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
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
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
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Environmental Physiology for Exercise, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013510
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
