UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of muscle power training on balance function and walking ability in elderly patients with heart failure
Title of the study (Brief title)	The effect of muscle power training on balance function and walking ability in elderly patients with heart failure
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elderly patients with heart failure tend to develop physical flails. Thus, there is concern that increased risk of falling, accompanying fracture, and transition to bedridden. The purpose of this study is to examine the effect of muscle power training in addition to normal cardiac rehabilitation program on the improvement of balance function and walking ability in elderly patients with heart failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Berg Balance Scale(Baseline, 12 weeks and 24 weeks after training)
Key secondary outcomes	Muscle power of quadriceps femoris and hamstrings, Timed Up and Go test,10m walking test, Short physical performance battery(Baseline, 12 weeks and 24 weeks after training)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	We will do muscle power training in addition to normal cardiac rehabilitation program(a total of 24 weeks, once a week)
Interventions/Control_2	We will do normal cardiac rehabilitation program alone for 12 weeks and then add 12-week muscle power training
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Heart failure patients
Key exclusion criteria	Severe heart failure patients with NYHA class III or more Patients who have severe arrhythmia (ventricular extrasystole over Lown Class III or complete left bundle branch block, other lethal arrhythmias) Patients whose blood pressure excessively rises or falls with exercise Patients who can not walk on flat ground by themselves Patients who are difficult to perform training due to cognitive decline, hemiplegia after stroke, joint pain due to exerciser disease, etc.
Target sample size	40

Research contact person
Name of lead principal investigator	Miyai Nobuyuki
Organization	Wakayama Medical University
Division name	Graduate school of Health and Nursing Science
Address	Wakayama prefecture Wakayama city Mikazura 580
TEL	073-446-6716
Email	miyain@wakayama-med.ac.jp

Public contact
Name of contact person	Sakaguchi Masato
Organization	Wakayama Medical University
Division name	Graduate school of Health and Nursing Science
Address	Wakayama prefecture Wakayama city Mikazura 580
TEL	080-5307-1376
Homepage URL
Email	n1711005@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	角谷リハビリテーション病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 04 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 10 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2018 Year 04 Month 03 Day
Last modified on	2018 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036550