UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042022
Receipt number R000047805
Scientific Title Effect of pulmonary tele-rehabilitation in patients with COPD: a randomized controlled trial.
Date of disclosure of the study information 2020/10/06
Last modified on 2023/04/10 08:16:46

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Basic information

Public title

Effect of pulmonary tele-rehabilitation in patients with COPD

Acronym

Effect of pulmonary tele-rehabilitation in patients with COPD

Scientific Title

Effect of pulmonary tele-rehabilitation in patients with COPD: a randomized controlled trial.

Scientific Title:Acronym

Effect of pulmonary tele-rehabilitation in patients with COPD: a randomized controlled trial.

Region

Japan


Condition

Condition

Chronic Obstructive Pulmonary Disease

Classification by specialty

Pneumology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effect of pulmonary tele-rehabilitation compared with centre based pulmonary rehabilitation in patiens with COPD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incremental Shuttle Walking Test (ISWT)

Key secondary outcomes

cardiopulmonary exercise test (CPET), daily step count, COPD Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), program sessions, acute exacerbation / hospitalization, Client Satisfaction Questionnaire-8 (CSQ-8)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

pulmonary tele-rehabilitation

Interventions/Control_2

centre based pulmonary rehabilitation

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

40 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Cases decided by a doctor to be indicated for pulmonary rehabilitation
Cases who can obtain a sufficient understanding of how to use the equipment of the tele-rehabilitation system by themselves or their housemates

Key exclusion criteria

Hospitalized due to exacerbation of respiratory failure within the past 4 weeks
Have a any serious comorbidities (eg, pulmonary hypertension, malignant tumor)

Target sample size

46


Research contact person

Name of lead principal investigator

1st name Kazuaki
Middle name
Last name Suyama

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Cardiopulmonary Rehabilitation Science

Zip code

852-8520

Address

1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture

TEL

095-819-7963

Email

kazuaki_s104@ret.bbiq.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Kozu

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Cardiopulmonary Rehabilitation Science

Zip code

852-8520

Address

1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture

TEL

095-819-7963

Homepage URL


Email

ryokozu@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tagami Hospital, Inoue Hospital, Integrity Healthcare Inc.

Name of secondary funder(s)

Philips Japan Inc.


IRB Contact (For public release)

Organization

Nagasaki University Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture

Tel

095-819-7198

Email

miyaji195@nagasaki-u.ac.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

2020 Year 10 Month 06 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

Open public recruiting

Date of protocol fixation

2020 Year 09 Month 23 Day

Date of IRB

2021 Year 01 Month 06 Day

Anticipated trial start date

2021 Year 11 Month 01 Day

Last follow-up date

2023 Year 03 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

2020 Year 10 Month 06 Day

Last modified on

2023 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name