UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on glucose metabolism of low-intensity exercise in elderly heart failure patients who have insulin resistance or type 2 diabetes mellitus
Title of the study (Brief title)	Effects on glucose metabolism of low-intensity exercise in elderly patients with heart failure
Region	Japan

Condition
Condition	Heart failure patients with abnormal glucose metabolism
Classification by specialty	Cardiology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For elderly heart failure patients with abnormal glucose metabolism, to verify low-intensity exercise is whether to improve glucose metabolism abnormalities, such as postprandial hyperglycemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Twenty four hour average blood sugar,prevalence of hyperglycemia over the course of 24h,Incremental area under the curve (IAUC)of 3 hours each postprandial Day, time activity level;amount of physical activity, number of steps, calories, mets
Key secondary outcomes	Full execution rate,Drop-out rate, Dietary intake,Blood pressure,Pulse

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	All subjects is carried out in a randomized cross-over study to test two of the non-exercise and low intensity exercise.Glycemic control was assessed during the subsequent 24h postexercise and no exercise period by continuous glucose monitoring.All subjects attached a total of 88 hours CGM(Medtronic ipro2).The study carried out in five days, including the washout period.Subjects of A group and was attached with a CGMS on the first day of the 16:00, Implementation for 35 minutes chair exercise is a low-intensity exercise in 9:30 of the second day;1.5to2.5Mets.Washout period of 46 hours after exercise, and rest 35 minutes from 9:30 as a non-exercise day to day 4.CGM removal at 10 the next day 5.The intake respectively 8:00, 12:00, 18:00 in the hospital diet during the study period.At least four daily SMBG measurements are obtained with a gluco-meter(One touch ultra vue,Johnson&Johnson) and enter into the CGMS for calibration.Evaluation of outcomes analyze the data in the Medtronic CareLink iPro software.All subjects are not permitted snacking,and exercise except for intervention during the study period.
Interventions/Control_2	All subjects is carried out in a randomized cross-over study to test two of the non-exercise and low intensity exercise.Glycemic control was assessed during the subsequent 24h postexercise and no exercise period by continuous glucose monitoring.All subjects attached a total of 88 hours CGM(Medtronic ipro2).The study carried out in five days, including the washout period.Subjects of B group and was attached with a CGMS on the first day of the 16:00,Implementation for rest 35 minutes from 9:30 as a non-exercise of the second day.Implementation for 35 minutes chair exercise is a low-intensity exercise in 9:30 of the day3;1.5to2.5Mets. Washout period of 46 hours after exercise, and CGM removal at 8 the day5.The intake respectively 8:00, 12:00, 18:00 in the hospital diet during the study period.At least four daily SMBG measurements are obtained with a gluco-meter(One touch ultra vue,Johnson&Johnson) and enter into the CGMS for calibration.Evaluation of outcomes analyze the data in the Medtronic CareLink iPro software.All subjects are not permitted snacking,and exercise except for intervention during the study period.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	a.Those who start cardiac rehabilitation in patients with heart failure in the hospital, or have started a rehabilitation already, who has passed for more than fourty eight hours from the previous exercise b.Age of consent at the time of obtaining 65 years of age or older c.Patients with HOMA-R> 2.5 or more or type2 diabetes patient (diabetes treatment guiding criterion) d.There is no change of oral during the period e.Patient consent was obtained in writing from the person for this study participants f.Patient with 6MWT<350m
Key exclusion criteria	a. Patients who are considered by the unstable mental state and decrease in comprehension, participation in this study is difficult b. Unstable patients with hemodynamic NYHA4, degrees arrhythmia control is unstable c. Severe disease; severe heart failure EF20% less than, severe Aortic stenosis, cirrhosis d. Patients who can not exercise and walk due to a failure functional by cerebrovascular disease and orthopedic problems e. Patients with inflammatory active disease f. Dialysis patient g.Patients with insulin therapy h. Patients of 300mg/dl or more fasting blood glucose or urine ketone positive i. After hepatic resection and post-gastrectomy j.The patients were determined to be unsuitable for the study by the physician
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuko Nin
Organization	Kyoto University Graduate School of Medicine,Human Health Sciences
Division name	Clinical Nursing Laboratory
Address	53 kawahara-cho,shogoin,sakyo-ku, kyoto
TEL	075-751-3946
Email	nin@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Soong Rae Cho
Organization	Kyoto University Graduate School of Medicine,Human Health Sciences
Division name	Clinical Nursing Laboratory
Address	53 kawahara-cho,shogoin,sakyo-ku, kyoto
TEL	075-751-3946
Homepage URL
Email	cho.soongrae.77u@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine,Human Health Sciences
Institute
Department

Funding Source
Organization	Osaka Gas Group Welfare Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

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	京都大学医学部附属病院(京都府) 和泉市立病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 05 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 01 Month 17 Day
Anticipated trial start date	2014 Year 03 Month 05 Day
Last follow-up date	2014 Year 12 Month 16 Day
Date of closure to data entry	2015 Year 01 Month 15 Day
Date trial data considered complete	2015 Year 02 Month 03 Day
Date analysis concluded	2015 Year 02 Month 03 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 04 Day
Last modified on	2019 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015555