UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032087
Receipt No. R000036550
Scientific Title The effect of muscle power training on balance function and walking ability in elderly patients with heart failure
Date of disclosure of the study information 2018/04/04
Last modified on 2018/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of muscle power training on balance function and walking ability in elderly patients with heart failure
Acronym The effect of muscle power training on balance function and walking ability in elderly patients with heart failure
Scientific Title The effect of muscle power training on balance function and walking ability in elderly patients with heart failure
Scientific Title:Acronym 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
1st name
Middle name
Last name Miyai Nobuyuki
Organization Wakayama Medical University
Division name Graduate school of Health and Nursing Science
Zip code
Address Wakayama prefecture Wakayama city Mikazura 580
TEL 073-446-6716
Email miyain@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakaguchi Masato
Organization Wakayama Medical University
Division name Graduate school of Health and Nursing Science
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036550

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.