UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033582
Receipt number R000038283
Scientific Title Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.
Date of disclosure of the study information 2018/08/01
Last modified on 2024/03/06 15:23:18

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Basic information

Public title

Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.

Acronym

Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.

Scientific Title

Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.

Scientific Title:Acronym

Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.

Region

Japan


Condition

Condition

Chronic respiratory disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of rehabilitation with low loading program teaching home-based physical exercise and a self-managed activity program using a pedometer and diary method on physical function, activities of dairy living(ADL), and quality of life(QOL) in patients with chronic respiratory disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

6-Minute Walk Test(6MWT)

Key secondary outcomes

Lung function, Isometoric knee extensiton strength, St George's Respiratory Questionnaire(SGRQ), Modified MRC dyspnea scale, COPD Assessment scale(CAT), The Nagasaki University Respiratory ADL questionnaire(NRADL), 30-second chair-stand test, Average number of steps a day


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

We teach home-based physical exercises to patients.Patients record the number of steps and self-evaluation of physical activity in a diary every day.We prompt them to increase 5% of the average number of steps in 1 month every month.Thease intervention will be held for 6 months.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The chronic respiratory disease patients visiting Jobu Hospital for Respiratory Disease.
The patients going to hospital regularly.
The patients who agreed in written to join this clinical trial.

Key exclusion criteria

The patients have any of sever heart, medical or orthopedic diseases and has judged by the treating physician to be inappropriate to participate in the study.

The patients with acute diseases, malignant disease, bronchial asthma, graphia or dementia.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Daigo
Middle name
Last name Kato

Organization

Gunma University

Division name

Graduate School of Health Science

Zip code

371-8514

Address

3-39-22,Showa,Maebashi,Gunma,JAPAN

TEL

027-220-8971

Email

katod.rpt@gmail.com


Public contact

Name of contact person

1st name Daigo
Middle name
Last name Kato

Organization

Gunma University

Division name

Graduate School of Health Science

Zip code

371-8514

Address

3-39-22,Showa,Maebashi,Gunma,JAPAN

TEL

027-220-8971

Homepage URL


Email

katod.rpt@gmail.com


Sponsor or person

Institute

Jobu hospital for respiratory diseases

Institute

Department

Personal name



Funding Source

Organization

Non

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

Institutional review board of Jobu hospital for respiratory diseases

Address

586-1, Taguchi, Maebashi, Gunma, JAPAN

Tel

027-232-5000

Email

ichiyokai-jkn@mvd.biglobe.ne.jp


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

2018 Year 08 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


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

2018 Year 07 Month 05 Day

Date of IRB

2018 Year 07 Month 25 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2024 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 01 Day

Last modified on

2024 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name