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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Ischemic
• Cerebrovascular Accident

Interventions

Type	Name	Description
OTHER	Low-intensity resistance exercise with blood flow restriction group (L-BFR)	The blood flow restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 40% of 1-RM. The SB protocol consists of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min recovery interval between sets and 3-min between exercises. Blood flow to the active muscle during training will be restricted by a blood flow restriction band (tourniquet) placed at the proximal end of the lower limbs. When the subjects performed training with BFR, the proximal portions of their lower limbs will be compressed at the pressure of 120-160 mmHg by electronically controlled air pressure belts. The air pressure belt will be inflated before the exercise and will remain inflated during one-minute intervals between the sets and will be deflated during the three-minute interval between the exercise.
OTHER	High-intensity resistance exercise without blood flow restriction group (H-BFR).	The high-intensity restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 80% of 1-RM. The SB protocol consist of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min rest interval between sets and 3-min between exercises.

Timeline

• Start date: 2022-03-20
• Primary completion: 2022-08-15
• Completion: 2022-12-15
• First posted: 2022-03-16
• Last updated: 2022-03-22

Locations

1 site across 1 country: Turkey (Türkiye)