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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001865
Receipt No. R000002244
Scientific Title Lifestyle intervention for prevention of stroke recurrence in mild stroke - A Randomized Controlled Trial -
Date of disclosure of the study information 2009/04/10
Last modified on 2013/04/19

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Basic information
Public title Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Acronym Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Scientific Title Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Scientific Title:Acronym Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Region
Japan

Condition
Condition mild stroke patients with large and small vessel disease
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of lifestyle intervention for stroke recurrence.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stroke Recurrence
Other cardiovascular event
(Myocardial infarction, Angina pectris,Peripheral artery disease)
Key secondary outcomes Blood Pressure
Low density lipoprotein
High density lipoprotein
HbA1c
HOMA-R
high sensitivity protein
n-3/n-6 fatty acid
FMD
CAVI
ABI
Waist circumference
The Hospital Anxiety and Depression Scale
Alcohol/exercise/smorking habit
Physical activity
Salt intake

Base
Study type

Study design
Basic design Parallel
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 NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Lifestyle Intervention (Exercise, Salt intake, Nutrition, standard medication)
Interventions/Control_2 Control (standard medication)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ischemic stroke with large and small vessel diseases
aged over 20 years old
mRS 0-2 (independent in mobility)
discharge directly to home
Key exclusion criteria The patient who have;
cognitive disorders (MMSE<18)
mental disorders
disability of communication
extracorporenal dialysis
hypercoagulable state
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Yamada
Organization Nagoya University
Division name School of Health Sciences
Zip code
Address 1-1-20, Daiko-minami, Higashi-ku, Nagoya
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Kono
Organization Nagoya University Graduate School of Medicine
Division name Program in Physical Therapy
Zip code
Address 1-1-20, Daiko-minami, Higashi-ku, Nagoya
TEL 052-719-1876
Homepage URL
Email el-condor-pasa@tiara.ocn.ne.jp

Sponsor
Institute Yamada Labolatory, School of Health Sciences, Nagoya University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This trial was terminated earlier than expected because the prespecified early stopping rule for efficacy had been met. After 2.9 years median follow-up period, 12 patients allocated the control group and 1 patient in the lifestyle intervention group experienced at least one vascular event. A sequential plans analysis indicated superiority of lifestyle intervention in interim analysis. Kaplan&#8211;Meier survival curves after log-rank test showed significant prognostic difference between randomized groups (P=0.005).
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 Terminated
Date of protocol fixation
2009 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information After 24 weeks intervention period, the intervention group showed a significant increase in daily physical activity and a significant decrease in salt intake (physical activity, P=0.012; salt intake, P<0.001), with a significant difference between the randomized groups (physical activity, P<0.001; salt intake, P=0.018). Similarly, BP were decreased and the HDL-C levels were increased in the intervention group (SBP; P < 0.001, HDL-C; P = 0.018), with significant differences between the randomized groups (SBP; P < 0.001, HDL-C; P = 0.022). In contrast, LDL-C, HbA1c and hs-CRP tended to decrease in the intervention group but did not indicate significance.

Management information
Registered date
2009 Year 04 Month 09 Day
Last modified on
2013 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002244

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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