Intermittent Fasting Following Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789409
• Other study ID #: chhwang11
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: December 2019
• Source: Ulsan University Hospital
• Contact: Chang Ho Hwang
• Phone: +82-52-250-7210
• Email: chhwang1220ciba[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Intermittent Fasting
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Dietary Supplement:
• Intermittent Fasting
The aforementioned intermittent fasting in arm/group descriptions.

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Mini mental status exam	Mini mental status exam(minimum of 0 and maximum scores of 30); 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
Other	Change of Beck depression inventory	Beck depression inventory(minimum of 0 and maximum scores of 63); 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
Other	Change of Wecsler aphasia battery	Wecsler aphasia battery(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
Other	Change of Berg balance scale	Berg balance scale(minimum of 0 and maximum scores of 56); 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
Other	Change of Functional Ambulation Category	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
Other	Change of Motricity Index	Motricity Index(minimum of 0 and maximum scores of 99); 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
Other	Change of 10m walking test	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
Other	Change of Grasping force (kg)	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
Other	Change of 9-hole pegboard	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
Other	Change of Jebsen Taylor test	Jebsen-Taylor Hand Function Test	1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
Other	Change of Nottingham sensory scale	Nottingham sensory scale(minimum of 0 and maximum scores of 20); 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
Other	Change of Arm motor Fugl-Mayer scale	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
Other	Change of Stroke impact scale	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
Other	Change of Ashworth scale	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
Other	Change of Knee joint kinesthesia	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
Other	Change of Behavioral inatention test	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
Other	Change of Apraxia screen of Tulia	Apraxia screen of (minimum of 0 and maximum scores of 12); 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
Other	Change of motor evoked potential	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.	1 day before the initiation of intervention, and 6 months after the stroke onset
Other	Change of Weight	Weight (Kg)	1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Other	Change of Temperature	temperature (Celsius)	1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Other	Change of Serum glucose level	Serum glucose level (mg/ml)	1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
Other	Change of Hypoglycemia-related severity	Assessment of hypoglycemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome.	every day following the start of intervention until 2 weeks of intervention
Primary	Change of Surface electromyography	root mean square and root peak square of compound motor action potential	1 day before the initiation of intervention, and 6 months after the stroke onset
Secondary	Change of Korean-modified Barthel index	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