UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007598 |
|---|---|
| Receipt number | 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 04:56:51 |
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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
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/
kimuaki@nifty.com
Sponsor or person
Institute
Gunma PAZ College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008978
