UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032087 |
|---|---|
| Receipt number | 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 14:37:17 |
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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
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
n1711005@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036550
