UMIN-CTR Clinical Trial

Basic information
Public title	Effects of heat stress and exercise training on exercise capacity, dyspnea, and health-related quality of life in patients with interstitial lung disease
Acronym	Effects of heat stress and exercise training in interstitial lung disease
Scientific Title	Effects of heat stress and exercise training on exercise capacity, dyspnea, and health-related quality of life in patients with interstitial lung disease
Scientific Title:Acronym	Effects of heat stress and exercise training in interstitial lung disease
Region	Japan

Condition
Condition	interstitial lung disease
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to establish the impact of heat stress and exercise training on exercise capacity, dyspnea, and health-related quality of life in patients with interstitial lung disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	6-min walk distance (6 and 12 weeks)
Key secondary outcomes	isometric quadriceps force quadriceps muscle thickness dyspnea (mMRC dyspnea scale) health-related QOL (SGRQ)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	heat stress
Interventions/Control_2	exercise training (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	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. diagnosis of ILD 2. mMRC dyspnea grade 2, 3 or 4 3. clinically stable for at least 4 weeks before recruitment 4. written, informed consent
Key exclusion criteria	1. severe orthopedic or neurological disorders 2. non-ambulatory 3. unstable cardiac disease 4. any type of pacemaker implantation 5. active skin disease or weakness of skin 6. previous participation in a pulmonary rehabilitation program
Target sample size	66

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Kozu
Organization	Nagasaki University
Division name	Department of Cardiopulmonary Rehabilitation, Graduate School of Biomedical Sciences
Zip code	852-8520
Address	1-7-1 Sakamoto, Nagasaki 852-8520
TEL	095-819-7963
Email	ryokozu@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Kozu
Organization	Nagasaki University
Division name	Department of Cardiopulmonary Rehabilitation, Graduate School of Biomedical Sciences
Zip code	852-8520
Address	1-7-1 Sakamoto, Nagasaki 852-8520
TEL	095-819-7963
Homepage URL
Email	ryokozu@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Graduate School of Biomedical Sciences
Address	1-7-1 Sakamoto
Tel	095-819-7963
Email	ryokozu@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	長崎呼吸器リハビリクリニック

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 15 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	Terminated
Date of protocol fixation	2016 Year 10 Month 01 Day
Date of IRB	2016 Year 04 Month 15 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2018 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 15 Day
Last modified on	2021 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031811