Clinical trial NCT03789409: Intermittent Fasting Following Acute Ischemic Stroke
Official title: Intermittent Fasting Following Acute Ischemic Stroke: Prospective, Randomized, Parallel Group, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Intermittent Fasting
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Surface electromyography
timeFrame: 1 day before the initiation of intervention, and 6 months after the stroke onset
Secondary outcomes:
measure: Change of Korean-modified Barthel index
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Other outcomes:
measure: Change of Mini mental status exam
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Beck depression inventory
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Wecsler aphasia battery
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Berg balance scale
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Functional Ambulation Category
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Motricity Index
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of 10m walking test
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Grasping force (kg)
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of 9-hole pegboard
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Jebsen Taylor test
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Nottingham sensory scale
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Arm motor Fugl-Mayer scale
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Stroke impact scale
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Ashworth scale
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Knee joint kinesthesia
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Behavioral inatention test
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of Apraxia screen of Tulia
timeFrame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
measure: Change of motor evoked potential
timeFrame: 1 day before the initiation of intervention, and 6 months after the stroke onset
measure: Change of Weight
timeFrame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
measure: Change of Temperature
timeFrame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
measure: Change of Serum glucose level
timeFrame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
measure: Change of Hypoglycemia-related severity
timeFrame: every day following the start of intervention until 2 weeks of intervention
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References: