Unique ID issued by UMIN | UMIN000001865 |
---|---|
Receipt number | 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 17:06:05 |
Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Lifestyle intervention for prevention of stroke recurrence in mild stroke
- A Randomized Controlled Trial -
Japan |
mild stroke patients with large and small vessel disease
Neurology | Rehabilitation medicine |
Others
NO
To clarify the effects of lifestyle intervention for stroke recurrence.
Efficacy
Confirmatory
Stroke Recurrence
Other cardiovascular event
(Myocardial infarction, Angina pectris,Peripheral artery disease)
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
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Behavior,custom |
Lifestyle Intervention (Exercise, Salt intake, Nutrition, standard medication)
Control (standard medication)
20 | years-old | <= |
Not applicable |
Male and Female
ischemic stroke with large and small vessel diseases
aged over 20 years old
mRS 0-2 (independent in mobility)
discharge directly to home
The patient who have;
cognitive disorders (MMSE<18)
mental disorders
disability of communication
extracorporenal dialysis
hypercoagulable state
140
1st name | |
Middle name | |
Last name | Sumio Yamada |
Nagoya University
School of Health Sciences
1-1-20, Daiko-minami, Higashi-ku, Nagoya
1st name | |
Middle name | |
Last name | Yuji Kono |
Nagoya University Graduate School of Medicine
Program in Physical Therapy
1-1-20, Daiko-minami, Higashi-ku, Nagoya
052-719-1876
el-condor-pasa@tiara.ocn.ne.jp
Yamada Labolatory, School of Health Sciences, Nagoya University
Ministry of Education, Culture, Sports, Science and Technology
NO
2009 | Year | 04 | Month | 10 | Day |
Published
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–Meier survival curves after log-rank test showed significant prognostic difference between randomized groups (P=0.005).
Terminated
2009 | Year | 03 | Month | 20 | Day |
2009 | Year | 04 | Month | 01 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
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.
2009 | Year | 04 | Month | 09 | Day |
2013 | Year | 04 | Month | 19 | Day |
Value
https://center6.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 |