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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007598
Receipt No. R000008978
Scientific Title Low intensity physical activity leads to improvement in brachial-ankle pulse wave velocity in the affected leg of hemiplegics
Date of disclosure of the study information 2012/03/29
Last modified on 2012/03/29

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Basic information
Public title Low intensity physical activity leads to improvement in brachial-ankle pulse wave velocity in the affected leg of hemiplegics
Acronym Low intensity physical activity leads to improvement in brachial-ankle pulse wave velocity in the affected leg of hemiplegics
Scientific Title Low intensity physical activity leads to improvement in brachial-ankle pulse wave velocity in the affected leg of hemiplegics
Scientific Title:Acronym Low intensity physical activity leads to improvement in brachial-ankle pulse wave velocity in the affected leg of hemiplegics
Region
Japan

Condition
Condition Cerebrovascular disorder
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We used pulse wave velocity (PWV) as an indicator of aortic distensibility and investigated whether low intensity physical activity (LIPA) administered to elderly hemiplegic patients may decrease aortic stiffness in the affected leg.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes brachial-ankle aortic PWV (baPWV)
Key secondary outcomes Several physical parameters were measured weekly in both groups, including: physical activity levels based on posture and intensity (PAPI), resting heart rate, systolic blood pressure (SBP), ankle-brachial pressure index (ABI), heart-aortic PWV (haPWV)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Interventions, LIPA was administered daily to the IG over 8 weeks, and was designed to increase the daily energy consumption by 40 cal/day compared to the individual baseline value. The exercises included half squats and passive ankle dorsiflexion-plantar flexion.
Interventions/Control_2 In the control group only the daily physical activity was measured.
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
Key inclusion criteria The inclusion criteria were: age above 65 years, male, hemiplegic, onset of stroke within 5 years, some of them required walking aid indoors, and all of them required a walking aid outdoors.
Key exclusion criteria 1) severe functional limitations that precluded any increase in PA, 2) presence of associated cardiovascular conditions such as uncontrolled hypertension or angina, 3) presence of undiagnosed or untreated health conditions that manifested as abnormal findings in laboratory test and contraindicated exercise tests.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Kimura
Organization Gunma PAZ College
Division name Physical Therapy
Zip code
Address 1-7-1, Tonyamachi, Takasaki, Gunma, JAPAN 370-0006
TEL 0273770865
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kimura
Organization Gunma PAZ College
Division name Physical Therapy
Zip code
Address 1-7-1, Tonyamachi, Takasaki, Gunma, JAPAN 370-0006
TEL 0273770865
Homepage URL http://kimuakilabo.main.jp/
Email kimuaki@nifty.com

Sponsor
Institute Gunma PAZ College
Institute
Department

Funding Source
Organization Kimura Akira Labo,Gunma PAZ College
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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 Comminity care Takakusa(Sizuoka), Aonashi Nursinghomein Paz Group(Gunma)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2004 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2004 Year 07 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 29 Day
Last modified on
2012 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008978

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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