Clinical trial NCT05281679: The Effects of Blood Flow Restriction With Low-intensity Resistance Training Versus Traditional Resistance Exercise on Lower Limb Strength, Walking Capacity, and Balance in Patients With Ischemic Stroke: (BFR-Stroke RESILIENCE Trial)
Official title: The Effects of Blood Flow Restriction With Low-intensity Resistance Training Versus Traditional Resistance Exercise on Lower Limb Strength, Walking Capacity, and Balance in Patients With Ischemic Stroke: (BFR-Stroke RESILIENCE Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Cerebrovascular Accident
Keywords: Blood flow restriction
Resistance exercise
Mobility
Walking capacity
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately causes mobility and functional limitation. Worldwide, the incidence of stroke has been increased by 30% in the last decade. In Europe, more than one million cases have been reported each year and six million stroke survivors are known to be alive till now. The annual estimated cause of stroke treatment in Europe is twenty-seven billion Euros. By 2030, it is estimated that the cost of stroke treatment will be triple the current amount and can reach up to 184 billion dollars. Therefore, it is necessary to develop an economical rehabilitation program that prevents or reduces long-term disability after stroke.

Detailed description: Blood flow restriction combined with resistance training may be an economic and time-efficient alternative to High-Intensity Training to manage the risk factors of stroke and can also be useful in reducing stroke-related impairment effectively. During BFRT, the blood flow of the exercising muscle is restricted by placing the inflated tourniquets at the most proximal part of the legs or arms. By restricting the blood flow to the limbs, the desired muscle group will work in an ischemic environment and can trigger a significant increase in muscle mass, power, and strength by recruiting the fast-twitch muscle fibers. BFRT could be a promising type of exercise for high-risk groups of patients such as Cardiovascular disease, stroke, etc, and the hypertrophy responses induced by is comparable to that produced by high-intensity training. It was found that BFRT and high-intensity training produced similar effects on both systolic, diastolic blood pressure, and heart rate (HR) in young individuals and older adults. Previous evidence from neurological studies showed that resistance combined with blood flow restriction can improve muscle strength, balance, walking capacity, and cognitive function in Multiple Sclerosis and spinal cord injury patients. Recent study showed that BFR combined with resistance training has improved brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) and rate of perceived exertion in ischemic stroke patients. Kaatsu training society also reported a few cases in which BFRT has produced a positive effect on the recovery of stroke patients, but the evidence is insufficient to support this assertion.

Eligibility criteria: Inclusion Criteria:

* All the participants will be evaluated to be in stable Cardio-vascular condition i,e ACSM Class B.
* 18 to 90 years of age.
* More than 1 month of stroke onset.
* First ever unilateral ischemic stroke.
* Being able to walk 10 m independently with or without an assistive device.
* Being an independent ambulator (Functional Ambulation Scale\>3).
* Muscle tension of the modified Ashworth scale was lower than grade.

Exclusion Criteria

* People with a history of mental illness.
* People with obvious cognitive impairments.
* Combination with peripheral neuropathy.
* Having resting blood pressure above 160/100 mmHg even after taking medications.
* Hemorrhagic stroke
* Cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardiomyopathy).
* Transient ischemic attack.
* By-pass surgery in the recent three months
* Any 0ther musculoskeletal problems that prevented the participants from doing resistance training
* People who have taken antipyretics, analgesics, dopamine, and other drugs that affect autonomic nerve function within 2 weeks.

Primary outcomes:
measure: Change score of Sit to stand Test
timeFrame: Baseline, Post-intervention (Approximately 5 weeks), follow-up (up to 3 Months)
measure: Change score of 10 Meter walk Test
timeFrame: Baseline, Post-intervention (Approximately 5 weeks)
measure: Change score of Timed up and Go Test (TUG)
timeFrame: Baseline, Post-intervention (Approximately 5 weeks)
measure: Change score of 6 Minute walk Test
timeFrame: Baseline, Post-intervention (Approximately 5 weeks)
measure: Change score of Barthel Index
timeFrame: Baseline, Post-intervention (Approximately 5 weeks)
Secondary outcomes:
measure: Change score of Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Post-intervention (Approximately 5 weeks)
measure: Attendance
timeFrame: Number of sessions attended will be measured during the 5 weeks of intervention protocol.
measure: Adverse Events
timeFrame: Any adverse event reported during the 5 weeks of intervention protocol.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Rustem Mustafaoglu, PhD
role: STUDY_CHAIR
References:
citation: Freitas EDS, Miller RM, Heishman AD, Aniceto RR, Larson R, Pereira HM, Bemben D, Bemben MG. The perceptual responses of individuals with multiple sclerosis to blood flow restriction versus traditional resistance exercise. Physiol Behav. 2021 Feb 1;229:113219. doi: 10.1016/j.physbeh.2020.113219. Epub 2020 Oct 24.
citation: Du X, Chen W, Zhan N, Bian X, Yu W. The effects of low-intensity resistance training with or without blood flow restriction on serum BDNF, VEGF and perception in patients with post-stroke depression. Neuro Endocrinol Lett. 2021 Aug 28;42(4):229-235. Online ahead of print.