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)

NCT05281679 | Unknown

• 1 other identifier: E-13022260-199-207631
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Cerebrovascular Accident

Keywords

Blood flow restriction; Resistance exercise; Mobility; Walking capacity

Outcome Measures

Primary Outcomes (5)

• Change score of Sit to stand Test

  Five time sit to stand test will be used to assess lower extremity muscle strength, balance and risk of fall in stroke patients. The test measure amount of time taken to complete five repetitions of sit to stand task. The test will be performed with standard height chair without an armrest and with straight back (43-45 cm high). He patients will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Timing began when the patient's back left the backrest and stopped once the back touched the backrest for the fifth time.

  Baseline, Post-intervention (Approximately 5 weeks), follow-up (up to 3 Months)

• Change score of 10 Meter walk Test

  The Comfortable 10-m Walk Test (10 MWT) will be used to determine the speed of comfortable walking. The test will be applied in a 14-m corridor. The patients will be instructed to walk comfortably and allowed to use walking aid. At the 2nd meter, the stopwatch will be started and stopped when the patient reached the 12th meter. Walking time and number of steps will be assessed to calculate gait speed (m/s), stride length (m), and cadence (steps/min). After three trials, the average of the three trials will be recorded as m/s.

  Baseline, Post-intervention (Approximately 5 weeks)

• Change score of Timed up and Go Test (TUG)

  The Timed Up \& Go test is a functional mobility test used to assess dynamic balance, transfer, and gait. The patient is instructed to stand up from a chair (46 cm high) with support for the arms, walk for a short distance (3 m), turn, go back and sit down as quickly as possible. The stopwatch will be used to measure the time to perform these tasks from start to end. The patients will be allowed to use their walking aids. After three trials, the average of the three trials will be recorded.

  Baseline, Post-intervention (Approximately 5 weeks)

• Change score of 6 Minute walk Test

  The walking distance will be measured by the 6 Minute walk Test (6MWT), the most commonly used for measuring the physical performance of individuals after stroke. The patients will be asked to walk as far as possible throughout the 30-meter course within 6 minutes by following the standardized instructions provided by the physiotherapist. Participants will be allowed by the physiotherapist to use aiding device if necessary. Physiotherapist will guard the participants during the walk test but will not offer any assistance or support to the participant.

  Baseline, Post-intervention (Approximately 5 weeks)

• Change score of Barthel Index

  The Barthel Index measures a person's performance in activities of daily living. The Barthel Index consists of 10 items of mobility and self care activities of daily living. This score will be measured on admission and at the end of intervention (at the end of 5th week). The minimum score is 0 and the maximum is 100. A higher score indicates a better outcome.

  Baseline, Post-intervention (Approximately 5 weeks)

Secondary Outcomes (3)

• Change score of Hospital Anxiety and Depression Scale (HADS)

  Baseline, Post-intervention (Approximately 5 weeks)

• Attendance

  Number of sessions attended will be measured during the 5 weeks of intervention protocol.

• Adverse Events

  Any adverse event reported during the 5 weeks of intervention protocol.

Study Arms (2)

Low-intensity resistance exercise with blood flow restriction group (L-BFR).

EXPERIMENTAL

All the participants in the low-intensity resistance exercise with blood flow restriction group (L-BFR) will receive 3 sessions of low-intensity resistance training with blood flow restriction for a total of 5 weeks.

Other: Low-intensity resistance exercise with blood flow restriction group (L-BFR)

High-intensity resistance exercise without blood flow restriction group (H-BFR).

ACTIVE COMPARATOR

All the participants in the high-intensity resistance exercise without blood flow restriction group (H-BFR) will receive 3 sessions of high-intensity resistance training without blood flow restriction for a total of 5 weeks.

Other: High-intensity resistance exercise without blood flow restriction group (H-BFR).

Interventions

Low-intensity resistance exercise with blood flow restriction group (L-BFR) OTHER

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.

Low-intensity resistance exercise with blood flow restriction group (L-BFR).

High-intensity resistance exercise without blood flow restriction group (H-BFR). OTHER

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.

High-intensity resistance exercise without blood flow restriction group (H-BFR).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the participants will be evaluated to be in stable Cardio-vascular condition i,e ACSM Class B.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, 34160, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33250152 BACKGROUND

• 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.

  PMID: 34436843 RESULT

• Ahmed I, Mustafaoglu R, Erhan B. The effects of low-intensity resistance training with blood flow restriction versus traditional resistance exercise on lower extremity muscle strength and motor functionin ischemic stroke survivors: a randomized controlled trial. Top Stroke Rehabil. 2024 May;31(4):418-429. doi: 10.1080/10749357.2023.2259170. Epub 2023 Sep 19.

  PMID: 37724785 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rustem Mustafaoglu, PhD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 16, 2022
• Study Start: March 20, 2022
• Primary Completion: August 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)