UMIN-CTR Clinical Trial

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

healthy person

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yamaguchi University Graduate School

Institute

Department

Personal name

Organization

Scientific research fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

01

Month

15

Day

Last modified on

2017

Year

08

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023761