UMIN-CTR Clinical Trial

Basic information
Public title	Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
Acronym	Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
Scientific Title	Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
Scientific Title:Acronym	Effects of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease
Region	Japan

Condition
Condition	Cardiovascular disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to examine the effect of exercise intensity above anaerobic threshold on exercise tolerance in patients with heart disease who visit a cardiac rehabilitation outpatient clinic.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peak oxygen intake
Key secondary outcomes

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	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Aerobic exercise was performed with an exercise intensity of 1/3 of the anaerobic threshold to the start of respiratory compensation. The period is 3 months. The equipment used is an exercise bike. The frequency was twice a week.
Interventions/Control_2	Aerobic exercise was performed at the anaerobic threshold. The period is 3 months. The equipment used is an exercise bike. The frequency was twice a week.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients undergoing cardiac rehabilitation in cardiovascular medicine and cardiovascular surgery Patients who have received sufficient explanation for participation in this study, and who have fully understood and agreed to the document freely.
Key exclusion criteria	Patients who do not have voluntary consent Patients judged by doctors and research staff as inappropriate for this study Patients with large infarct size (CK: 10000 or more) Patients who still have severe coronary stenosis Patients with left ventricular ejection fraction of less than 40% Patients with atrial fibrillation (including mild atrial fibrillation) Patients with renal dysfunction (serum creatinine 1 or higher) (including dialysis patients)
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Tagashira Middle name Last name Satoshi
Organization	Nozaki Tokushukai Hospital
Division name	Department of rehabilitation
Zip code	574-0074
Address	2-10-50 Tanikawa, Daito City, Osaka, Japan
TEL	0728471641
Email	gasira1981@yahoo.co.jp

Public contact
Name of contact person	1st name Tagashira Middle name Last name Satoshi
Organization	Nozaki Tokushukai Hospital
Division name	Department of rehabilitation
Zip code	574-0074
Address	2-10-50 Tanikawa, Daito City, Osaka, Japan
TEL	0728471641
Homepage URL
Email	gasira1981@yahoo.co.jp

Sponsor
Institute	Medical corporation Tokushukai Nozaki Tokushukai Hospital
Institute
Department

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	Nozaki Tokushukai Hospital Clinical Trials Center
Address	2-10-50 Tanikawa, Daito City, Osaka, Japan
Tel	072-874-1641
Email	gasira1981@yahoo.co.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	2019 Year 12 Month 11 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	64
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 03 Month 25 Day
Date of IRB	2018 Year 05 Month 22 Day
Anticipated trial start date	2018 Year 05 Month 24 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 06 Month 01 Day
Date analysis concluded	2020 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2019 Year 12 Month 10 Day
Last modified on	2022 Year 12 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044296