Intermittent Fasting, Ischemic Stroke
Conditions
Brief summary
Despite numerous kinds of evidence on functional health and CNS protection of intermittent fasting after injuries were found in many brain-, and spinal cord-damaged animal models, there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral infarction. The aim of this study is to evaluate the neurological, functional and clinical efficacy of intermittent fasting in patients after acute ischemic stroke.
Detailed description
In order to verify the validity and clinical efficacy of intermittent fasting for neurological and functional effects of ischemic cerebral infarction, the first ischemic stroke (diagnosed within 1 year through brain MRI / CT) patients will be randomly assigned to intermittent fasting group or control group. In both groups, physical therapy, occupational therapy and speech therapy will be provided during 3 hours in total a day. The intermittent fasting group should maintain intermittent fasting for no less than 12 hours or more every day during the rehabilitation period (at least 1 week), and the control group is able to eat all of the hospital meals and all the participants want without any time limit. The efficacy of intermittent fasting is to be verified by performing the electro-physiological tests and functional evaluations before participation, 1st week, 2nd weeks after participation, before discharge, 3 months, and 6 months after the stroke onset.
Interventions
DIETARY_SUPPLEMENTIntermittent Fasting
The aforementioned intermittent fasting in arm/group descriptions.
Sponsors
Ulsan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who was diagnosed first ischemic stroke within preceeding 1 year through brain MRI/CT
Exclusion criteria
* Musculo-skeletal disease with limbs malformation or joint contracture * Weigh more than 135 kg or taller than 195 cm * Diabetes mellitus * unstable patient in neurology * Refusal of participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Surface electromyography | 1 day before the initiation of intervention, and 6 months after the stroke onset | root mean square and root peak square of compound motor action potential |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Korean-modified Barthel index | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Korean version-Modified Barthel Index (minimum of 0 and maximum scores of 100); higher values and a better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of Wecsler aphasia battery | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Wecsler aphasia battery(minimum of 0 and maximum scores of 100); higher values and a better outcome. |
| Change of Berg balance scale | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Berg balance scale(minimum of 0 and maximum scores of 56); higher values and a better outcome. |
| Change of Functional Ambulation Category | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Functional Ambulation Category(minimum of 0 and maximum scores of 5); higher values and a better outcome. |
| Change of Motricity Index | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Motricity Index(minimum of 0 and maximum scores of 99); higher values and a better outcome. |
| Change of 10m walking test | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | 10m walking test |
| Change of Grasping force (kg) | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Grasping force (kg) |
| Change of 9-hole pegboard | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | 9-hole pegboard |
| Change of Jebsen Taylor test | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Jebsen-Taylor Hand Function Test |
| Change of Nottingham sensory scale | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Nottingham sensory scale(minimum of 0 and maximum scores of 20); higher values and a better outcome. |
| Change of Arm motor Fugl-Mayer scale | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Arm motor Fugl-Mayer scale; wrist & hand/proximal arm(minimum of 0 and maximum scores of 24 and of 34, respectively ); higher values and a better outcome. |
| Change of Mini mental status exam | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Mini mental status exam(minimum of 0 and maximum scores of 30); higher values and a better outcome. |
| Change of Ashworth scale | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Ashworth scale; elbow, wrist, knee & ankle(minimum of 0 and maximum scores of 4); higher values and a worse outcome. |
| Change of Knee joint kinesthesia | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | The smallest iso-kinetic angle from which the participants could detect any passive flexion or extension movement of their own knee, using Biodex; (minimum of 0 and maximum scores of 360 degree); higher values and a worse outcome. |
| Change of Behavioral inatention test | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Behavioral inatention test(minimum of 0 and maximum scores of 146); higher values and a better outcome. |
| Change of Apraxia screen of Tulia | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Apraxia screen of (minimum of 0 and maximum scores of 12); higher values and a better outcome. |
| Change of motor evoked potential | 1 day before the initiation of intervention, and 6 months after the stroke onset | Amplitude (uV) of motor evoked potential was recorded on abductor pollicis brevis and extentor digitorum brevis following trans-cranial magnetic stimulation for cortico-spinal excitability. |
| Change of Weight | 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention | Weight (Kg) |
| Change of Temperature | 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention | temperature (Celsius) |
| Change of Serum glucose level | 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention | Serum glucose level (mg/ml) |
| Change of Hypoglycemia-related severity | every day following the start of intervention until 2 weeks of intervention | Assessment of hypoglycemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome. |
| Change of Stroke impact scale | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Hand motor, Stroke Impact Scale (minimum of 12 and maximum scores of 60); higher values and a better outcome. |
| Change of Beck depression inventory | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset | Beck depression inventory(minimum of 0 and maximum scores of 63); higher values and a worse outcome. |
Countries
South Korea
Contacts
Primary ContactChang Ho Hwang
Outcome results
None listed