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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020587
Receipt No. R000023761
Scientific Title Effect of pedaling exercise in bed on breathing function, muscular strength of lower limbs and motivation.
Date of disclosure of the study information 2016/02/01
Last modified on 2017/08/09

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Basic information
Public title Effect of pedaling exercise in bed on breathing function, muscular strength of lower limbs and motivation.
Acronym Effect of pedaling exercise in bed on breathing function, muscular strength of lower limbs and motivation.
Scientific Title Effect of pedaling exercise in bed on breathing function, muscular strength of lower limbs and motivation.
Scientific Title:Acronym Effect of pedaling exercise in bed on breathing function, muscular strength of lower limbs and motivation.
Region
Japan

Condition
Condition healthy person
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to find out effect of pedaling exercise in bed on breathing function, muscular strength of lower limbs and motivation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measuring before and after of intervention the following items:vital signs,SpO2,lung capacity,forced expiratory volume in 1 second,forced expiratory volume% in 1 second,respiratory tidal volume,respiratory minute volume, strength of quadriceps muscles and Borg scale.
Key secondary outcomes Measuring during intervention the following items : SpO2,heart rate,respiratory tidal volume,respiratory minute volume, respiratory frequency,end-expiratory oxygen concentration,maximum oxygen intake,tissue oxigen metabolism of lower limbs.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Group of standard rehabilitation
Person carry out a deep breathing exercise in Semifara position on bed for 15 minutes
Interventions/Control_2 Group of pedaling exercise
Person carry out pedaling exercise in Semifara position on bed for 15 minutes
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
45 years-old >=
Gender Male and Female
Key inclusion criteria more than 20 years old and less than 45 years old
Key exclusion criteria Person with a history of no smoking
Person with less than FEV1.0% 70% and less than %VC 80% by an examination for Spirometry
Person with movement limitation by doctor's order
Person with a history of heart disease
Person with injury part and prominent edema of lower limbs
Person with a history of varicose Veins of lower limbs
Person with a history of DVT
Person with body temperature more than 38 degree
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Saeki
Organization Yamaguchi University Graduate School of Medicine
Division name Faculty of Health Science
Zip code
Address 1-1-1 Minani Kogushi, Ube, Yamaguchi
TEL 0836-22-2817
Email kyo0651@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoko Saeki
Organization Yamaguchi University Graduate School of Medicine
Division name Faculty of Health Science
Zip code
Address 1-1-1 Minani Kogushi, Ube, Yamaguchi
TEL 0836-22-2817
Homepage URL
Email kyo0651@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School
Institute
Department

Funding Source
Organization Scientific research fund
Organization
Division
Category of Funding Organization Other
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 02 Month 01 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
This study investigated the effects of breathing function, muscular strength of lower limbs and motivation that the rehabilitation by the pedaling exercise in bed. In healthy,
the end-point of the breathing function was significantly higher than standard rehabilitation by the lower limbs pedaling exercise generally, and the pulse was significantly high, and it was found that circulation was promoted from results of the tissue metabolism index of lower limbs. Because the lower limbs muscular strength was short-term intervention, there was not the effect. In the end-point of the will, lower limbs pedaling exercise showed the actual feeling that exercised.
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 Completed
Date of protocol fixation
2016 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 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
2016 Year 01 Month 15 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023761

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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