Intermittent Fasting Following Acute Ischemic Stroke

• ClinicalTrials.gov Identifier: NCT03789409
• Recruitment Status: Recruiting
• First Posted: December 28, 2018
• Last Update Posted: July 10, 2019
• Sponsor: Ulsan University Hospital
• Information provided by (Responsible Party): Chang Ho Hwang, Ulsan University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ischemic Stroke; Intermittent Fasting	Dietary Supplement: Intermittent Fasting	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intermittent Fasting Following Acute Ischemic Stroke: Prospective, Randomized, Parallel Group, Controlled Trial
• Actual Study Start Date: March 4, 2019
• Estimated Primary Completion Date: January 31, 2020
• Estimated Study Completion Date: January 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Dietary Supplement: Intermittent Fasting; The aforementioned intermittent fasting in arm/group descriptions.
No Intervention: Ad libitium; Participants will be allowed to have hospital meals and all the desired intake without time limit.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change of Korean-modified Barthel index [ Time Frame: 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 Outcome Measures:

1. Change of Mini mental status exam [ Time Frame: 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.
2. Change of Beck depression inventory [ Time Frame: 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.
3. Change of Wecsler aphasia battery [ Time Frame: 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.
4. Change of Berg balance scale [ Time Frame: 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.
5. Change of Functional Ambulation Category [ Time Frame: 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.
6. Change of Motricity Index [ Time Frame: 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.
7. Change of 10m walking test [ Time Frame: 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
8. Change of Grasping force (kg) [ Time Frame: 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)
9. Change of 9-hole pegboard [ Time Frame: 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
10. Change of Jebsen Taylor test [ Time Frame: 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
11. Change of Nottingham sensory scale [ Time Frame: 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.
12. Change of Arm motor Fugl-Mayer scale [ Time Frame: 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.
13. Change of Stroke impact scale [ Time Frame: 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.
14. Change of Ashworth scale [ Time Frame: 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.
15. Change of Knee joint kinesthesia [ Time Frame: 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.
16. Change of Behavioral inatention test [ Time Frame: 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.
17. Change of Apraxia screen of Tulia [ Time Frame: 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.
18. Change of motor evoked potential [ Time Frame: 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.
19. Change of Weight [ Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention ]
    Weight (Kg)
20. Change of Temperature [ Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention ]
    temperature (Celsius)
21. Change of Serum glucose level [ Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention ]
    Serum glucose level (mg/ml)
22. Change of Hypoglycemia-related severity [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Chang Ho Hwang; +82-52-250-7210; chhwang1220ciba@gmail.com

Locations

Korea, Republic of

Ulsan University Hospital; Recruiting

Ulsan, Korea, Republic of, 682-714

Contact: Chang Ho Hwang, M.D., Ph.D. +82-52-250-7210 chhwang1220ciba@gmail.com

Principal Investigator: Chang Ho Hwang, M.D., Ph.D.

Sponsors and Collaborators

Ulsan University Hospital

Investigators

• Study Director: Chang Ho Hwang, M.D., Ph.D.; Ulsan University Hospital

More Information

• Responsible Party: Chang Ho Hwang, Associate Professor, Ulsan University Hospital
• ClinicalTrials.gov Identifier: NCT03789409 History of Changes
• Other Study ID Numbers: chhwang11
• First Posted: December 28, 2018
• Last Update Posted: July 10, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Cerebral Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia