UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033093
Receipt number R000037694
Scientific Title The effect of comprehensive respiratory rehabilitation using cloud system on exacerbation of patients with chronic obstructive pulmonary disease at home
Date of disclosure of the study information 2018/07/01
Last modified on 2021/06/12 14:52:25

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Basic information

Public title

The effect of comprehensive respiratory rehabilitation using cloud system on exacerbation of patients with chronic obstructive pulmonary disease at home

Acronym

The effect of cloud system on exacerbation of patients with chronic obstructive pulmonary disease

Scientific Title

The effect of comprehensive respiratory rehabilitation using cloud system on exacerbation of patients with chronic obstructive pulmonary disease at home

Scientific Title:Acronym

The effect of cloud system on exacerbation of patients with chronic obstructive pulmonary disease

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease

Classification by specialty

Pneumology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to clarify whether to prevent exacerbation by comprehensive respiratory rehabilitation at home using cloud system

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of exacerbations of chronic obstructive pulmonary disease 24 months after randomization

Key secondary outcomes

Daily physical activity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

For the intervention group,comprehensive respiratory rehabilitation is performed using a multi-occupational cooperation tool by Vital Link (Teijin Pharma, Tokyo),and the control group is treated as usual.
The program is about 1.exercise therapy, 2. Physical activity instruction in daily life, 3. Patient education, and when intervening at the time of visit, the nurse and the caregiver confirm and intervene the contents of 1 - 3.
After the intervention, the nurse and the caregiver states Program implementation status, content change and continuation.

Interventions/Control_2

Performing a usual care in the control group

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

65 years-old <=

Age-upper limit

120 years-old >

Gender

Male and Female

Key inclusion criteria

50 subjects who are in a stable period not suffering from exacerbations and infectious diseases such as pneumonia in patients with chronic obstructive pulmonary disease (COPD) who are seeking a Shinshu University Medical School affiliated hospital or a research cooperation facility (to be recruited) . Those that meet the eligibility criteria of 1 to 4 below are targeted. 1. Patients aged 65 years or older diagnosed with COPD (Guidelines for Diagnosis and Treatment of COPD 4th Edition, Japan Respiratory Society) 2. Shinshu University Medical School Hospital for the purpose of diagnosis and treatment of COPD Patients who visited research collaborative facilities (to be recruited) 3. Patients who obtained informed consent for this study 4. Patients who are involved in visiting rehabilitation, nursing caregivers, or caregivers

Key exclusion criteria

1. Patients suffering from exacerbation and respiratory infection within 3 months
2. Patients who are impaired in walking or writing on question paper due to the influence of exercise function or cognitive function or difficult patients
3. Patients with complications such as severe heart failure

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shohei Kawachi

Organization

Shinshu university hospital

Division name

Rehabilitation department

Zip code


Address

3-1-1 Asahi, Matsumoto Nagano Japan 390-8621

TEL

0263-37-2836

Email

drodman@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shohei Kawachi

Organization

Shinshu university hospital

Division name

Rehabilitation department

Zip code


Address

3-1-1 Asahi, Matsumoto Nagano Japan 390-8621

TEL

0263-37-2836

Homepage URL


Email

drodman@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

none

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

2018 Year 07 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 01 Day

Date of IRB

2018 Year 06 Month 05 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2018 Year 07 Month 31 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 06 Month 21 Day

Last modified on

2021 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037694


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name