Intermittent Fasting Following Acute Ischemic Stroke

Intermittent Fasting Following Acute Ischemic Stroke: Prospective, Randomized, Parallel Group, Controlled Trial

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.

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.

Over rehabilitation treatment during and admission (at least 1 week), intermittent fasting (IF) for more than 12 hours (water can be allowed). For subgroup assignment, participants can choose IF1 (eat early in the evening and late in the morning) or Post-IF2 (eat the remaining two meals without breakfast), depending on own their faver.

Korean version-Modified Barthel Index (minimum of 0 and maximum scores of 100); higher values and a better outcome.

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

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.

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

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.

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.

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.

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.

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.

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset

1 day before the initiation of intervention and 3rd week after start of intervention, 3 months 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.

Assessment of hypoglycemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome.

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