The Short-term Effect of Low-load Resistance Training with Blood-flow Restriction on Somatosensory-evoked Potentials in Healthy Young Adults

NCT06762912 | Not Yet Recruiting

• 1 other identifier: BFRT-SSEP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the short-term effect of lower limb BFRT on the somatosensory processing and related changes in SSEP amplitude and latency. The main questions it aims to answer are:

• Is there an effect of short-term application of BFRT on the somatosensory system?
• How do different cuff widths affect the somatosensory system?
• How do three different cuff widths affect perceived pain? Researchers will compare 3 different cuff widths to see if different cuff widths affect the somatosensory system and perceived pain. Participants will:
• Undergo 3 experimental sessions, sessions will be separated by 72 hours and the order of the sessions to be randomly selected.
• Perform low-load resistance training with blood flow restriction.

Conditions

The Current Study Focuses on Investigating the Short-term Effect of BFRT on the Somatosensory System Among Healthy Young Adults

Keywords

Blood Flow Restriction Training; Somatosensory Evoked Potentials; Neuroplasticity; Pain

Outcome Measures

Primary Outcomes (1)

• Somatosensory-evoked Potential

  SSEP is a reliable, reproducible, and frequently employed to detect alterations in electrophysiological conduction within the central and peripheral nervous pathways. The assessment of SSEP will involve the placement of electrodes for tibial nerve stimulation at the ankle, which includes both stimulating and recording electrodes.

  1st Session: Before BFR cuff. During (4 times, 2 min apart). After (4 times, 5 min apart). 2nd & 3rd Sessions: Before exercise with/without BFR cuff. During (4 times, after each set, during rest period). After (4 times, 5 min apart).

Secondary Outcomes (1)

• Perceived Pain

  Immediately after each session: - Rate perceived pain during the session (BFR cuff application and resistance exercise). - Rate if they are currently experiencing pain.

Study Arms (3)

Passive application of BFR cuff

EXPERIMENTAL

Other: Passive application of BFR cuff

Resistance exercise with BFR

EXPERIMENTAL

Other: Resistance exercise with BFR

Resistance exercise without BFR

EXPERIMENTAL

Other: Resistance exercise without BFR

Interventions

Passive application of BFR cuff OTHER

The first experimental session will start by conducting the one repetition maximum (1-RM) test of unilateral knee extension of the dominant leg, in which the dominant side was identified by asking the participants which side they will use to kick a ball. Before conducting the 1-RM test, 5 minutes warm-up on the cycle ergometer at 75W will be done. Calibration of the dynamometer will be done before operating the machine with each participant, then the participant will be positioned on the dynamometer seat comfortably with ensuring the back is supported and the knee is aligned with the axis of rotation. The participant will be asked to complete one successful repetition of knee extension through full range of motion (ROM), with increasing load until the participant can no longer complete full knee extension ROM, 3 minutes of rest will be allowed between attempts until the 1-RM is identified.

Passive application of BFR cuff

Resistance exercise with BFR OTHER

For both experimental sessions 2 and 3, the order of exercise condition will be randomly selected, either to be (1) the application of BFR cuff with resistance exercise, or (2) resistance exercise without the application of BFR cuff to decrease the incidence of learning effect. Cuff pressure during the application of BFR will be standardized to 50% of AOP. The resistance exercise for both experimental sessions 2 and 3 will be exactly similar and will involve four sets of isometric knee extensions at an intensity of 20% of 1-RM with repetitions of 30, 15, 15, and 15 by using the isokinetic dynamometer machine, which has a good to excellent test-retest reliability for knee extension movement with ICC value of 0.95-0.99. To minimize cognitive and neuromuscular fatigue, the experimental sessions will be separated by a minimum of three days (72 hours).

Resistance exercise with BFR

Resistance exercise without BFR OTHER

For both experimental sessions 2 and 3, the order of exercise condition will be randomly selected, either to be (1) the application of BFR cuff with resistance exercise, or (2) resistance exercise without the application of BFR cuff to decrease the incidence of learning effect. Cuff pressure during the application of BFR will be standardized to 50% of AOP. The resistance exercise for both experimental sessions 2 and 3 will be exactly similar and will involve four sets of isometric knee extensions at an intensity of 20% of 1-RM with repetitions of 30, 15, 15, and 15 by using the isokinetic dynamometer machine, which has a good to excellent test-retest reliability for knee extension movement with ICC value of 0.95-0.99. To minimize cognitive and neuromuscular fatigue, the experimental sessions will be separated by a minimum of three days (72 hours).

Resistance exercise without BFR

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be included if they are aged 18-30 years of both genders, with no history of cardiovascular problems or osteo-articular problems in the lower limbs, and if they responded negatively to all items of the Physical Activity Readiness Questionnaire (PAR-Q).
• Participants will be included if they have a body mass index (BMI) less than 25 or non-overweight individuals.
• Use of the long international physical activity questionnaire (L-IPAQ) to ensure all participants have equal physical activity levels.

You may not qualify if:

• Participants will be excluded if they were diagnosed with any neurological disease.
• Participants will be excluded if they have had any musculoskeletal injury in the past 3 months to avoid potential effect on their physical activity levels.

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, United Arab Emirates

Location

Related Publications (17)

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Taif A. M. Omran, Master's Student

CONTACT

+971551610573; u23102812@sharjah.ac.ae

Dr. Tamer Mohamed Shousha, PhD

CONTACT

+971562224469; tshousha@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Model Details: Participants will be randomly assigned to one of the three groups: small cuff width (5 cm), medium cuff width (12 cm), and large cuff width (18 cm). Each participant in all three groups will enroll in the three experimental sessions in a random order. All experimental sessions will be provided by the same physiotherapist to minimize the inter-rater variations.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 8, 2025
• Study Start: January 20, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

AE (1)