Intermittent Fasting Following Acute Ischemic Stroke: Prospective, Randomized, Parallel Group, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ulsan University Hospital
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change of Surface electromyography
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intermittent Fasting
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.
Intervention: Intermittent Fasting (Dietary Supplement)
Ad libitium
Participants will be allowed to have hospital meals and all the desired intake without time limit.
Outcomes
Primary Outcomes
Change of Surface electromyography
Time Frame: 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 Outcomes
- 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)
Investigators
Chang Ho Hwang
Associate Professor
Ulsan University Hospital