Effect of Cross-Education in Blood Flow Restriction Resistance Training on Lower Limbs in Older Women

NCT07155967 | Enrolling By Invitation

• 1 other identifier: 86845325.1.0000.5402
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Unilateral resistance training has been shown to promote strength adaptations in the directly trained limb and also improve strength in the contralateral limb, a phenomenon known as cross-education (CE), with more pronounced effects observed in high-load training. However, high-load resistance training may be unfeasible for older adults. Blood flow restriction (BFR) training emerges as a low-load alternative that reduces joint stress, is easy to apply, and has low cost. Although there is already evidence showing significant effects of CE during resistance training with BFR, gaps remain regarding its applicability in older adults. This study aims to evaluate the effects of CE in resistance training with BFR on the lower limbs of older women.

Conditions

Muscle Strength; Hypertrophy

Keywords

Elderly population; Strength training; Physical exercise; Lower limb; Blood flow restriction therapy

Outcome Measures

Primary Outcomes (15)

• Muscle strength assessment

  The one-repetition maximum (1RM) test will be used to assess muscle strength, as well as to prescribe the training protocol. It will be performed bilaterally during the initial, intermediate, and final assessments. Initially, participants will perform one repetition to familiarize themselves with the knee extension movement, followed by 10 warm-up repetitions using a load of 30-40% of the estimated 1RM. After the warm-up, the test will begin with a load equivalent to 20% of the participant's body mass, considering the target muscle group (quadriceps muscle). Load will then be progressively increased by 5-10% with each attempt. The participant must perform only one repetition per attempt. If successful, a rest interval of 3 to 5 minutes will be given before the next load increment and attempt. The 1RM is defined as the highest load the participant can lift once with proper form, without any compensatory movements. The test is considered valid if the participant reaches their maximum.

  3 days (baseline, mid-intervention, and final assessment)

• Ultrasound

  The assessment of the muscular structure will be carried out using ultrasound images of the participant's lower limbs, which will be captured using BodyMetrix BX-2000. Participants will be assessed in the supine position with legs fully extended and muscles relaxed. The ultrasound transducer will be covered with water-soluble transmission gel and positioned perpendicular to the skin over the muscle.

  3 days (baseline, mid-intervention, and final assessment)

• Quadriceps circumference

  Thigh circumference measurements will be taken at the proximal, medial, and distal positions, with the participant standing upright, heels approximately 10 cm apart, and body weight evenly distributed between both feet. For all measurements, the evaluator should position themselves so that their line of sight is level with the measurement site. Three non-consecutive measurements will be performed at each site, and the highest value will be recorded. A marker pen will be used to identify the exact anatomical locations for measurement.

  3 days (baseline, mid-intervention, and final assessment)

• Arterial pressure

  It will be collected with a sphygmomanometer

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Heart rate

  Heart rate will be continuously monitored using a portable heart rate monitor, Polar® RS800cx model (Polar Electro OY, Finland).

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Oxygen saturation

  Oxygen saturation will be measured using a fingertip pulse oximeter (ChoiceMMED - MD300C1 Fingertip, China), attached to the right index finger of each participant.

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Subjective Pain Assessment

  Subjective pain assessment will be obtained using the Visual Analog Scale (VAS), graded from 0 to 10, with zero indicating no pain and 10 representing the maximum level of pain tolerated by the participant, as described by Ferreira et al. Participants will be asked about the presence of pain in the dominant and non-dominant lower limbs, identifying on the scale the number corresponding to their current pain intensity.

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Subjective Perception of Discomfort

  Subjective perception of discomfort will be assessed using the Borg CR-10 scale, representing the perception of discomfort, with 0 corresponding to "no discomfort" and 10 to "maximum discomfort." Participants will be asked to report the discomfort perceived immediately after unilateral training with blood flow restriction (BFR). It should be noted that although the Borg CR-10 scale is not specifically designed for this purpose, it is commonly used in the BFR literature. The scale will be presented to participants in a way that prevents influence from the researcher.

  6 weeks (immediately after the training sessions)

• Subjective Perception of Recovery

  Subjective perception of recovery of the lower limb subjected to the exercise protocol will be assessed using a 10-point Likert scale, where 1 indicates "not recovered" and 10 "fully recovered." The scale will be presented to participants in a way that prevents influence from the researcher. The question will first be asked for the dominant lower limb and subsequently for the non-dominant lower limb.

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Subjective Perception of Effort

  The Borg Rating of Perceived Exertion (RPE) scale (45) is an instrument used to assess the subjective perception of effort generated during a given activity. This instrument, proposed by Borg, consists of a 0 to 10-point scale (CR-10), where participants select the descriptor and number that best reflect their psychophysiological stress related to the exercise. Before the exercise, participants will receive instructions on how to accurately respond to the RPE scale. Participants will report their perceived effort while looking at the scale, where 0 indicates "no effort" and 10 indicates "maximal effort."

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Myotonometry

  Muscle tone, stiffness, and elasticity of the quadriceps femoris will be assessed using the MyotonPRO® device (MyotonAS, Tallinn, Estonia). The device will be positioned at two-thirds of the distance between the anterior superior iliac spine (ASIS) and the superior pole of the patella, 4 cm above the base of the patella, 15 cm below the ASIS, at the midpoint between the patella and the anterior inferior iliac spine (AIIS), and 2 cm medially and 2 cm laterally from the midpoint. The device will be placed perpendicular to the assessed region, applying a light pre-load pressure, controlled at 0.18 N of initial compression of the subcutaneous tissue. Subsequently, an additional impulse of 0.40 N will be released for 15 ms, inducing tissue oscillation, which will then be dampened or attenuated.

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Bioelectrical impedance analysis

  Bioimpedance will be measured using a tetrapolar device (BIA Analyzer, 50 kHz, 800 µA). Electrodes will be positioned on the quadriceps femoris muscles. Analyzed variables will include resistance (R), reactance (Xc), phase angle (PhA), and tolerance ellipse, via Bioscan software.

  9 weeks (at baseline, mid-intervention, and post-intervention, as well as before and immediately after training sessions)

• Functional mobility

  The Timed Up and Go (TUG) test is a simple and quick physical test used to assess and classify functional mobility and fall risk in older adults. A time of up to 10 seconds is considered normal for healthy and independent individuals; 11 to 20 seconds are considered partially independent, with impairment and/or low risk of falls; 21 to 29 seconds indicates a moderate risk of falls; and more than 30 seconds suggests impaired physical mobility and a high risk of falls.

  3 days (baseline, mid-intervention, and final assessment)

• Physical performance

  The Short Physical Performance Battery (SPPB) assesses physical performance and includes three domains: semi-static balance, lower limb strength, and gait speed. Each test has a maximum score of 4 points, and the total score is the sum of the three tests, with a maximum of 12 points. The final classification is as follows: 0-3 points - disability or poor performance; 4-6 points - low performance; 7-9 points - moderate performance; 10-12 points - good performance.

  3 days (baseline, mid-intervention, and final assessment)

• Agility and dynamic balance test

  The Agility and Dynamic Balance (AGIL) test is part of the AAHPERD test battery, in which tasks similar to daily functional fitness activities are performed. Reference values for older women: 10.3-19.5 seconds - very good; 19.6-21.4 seconds - good; 21.5-23.6 seconds - fair; 23.7-26.4 seconds - poor; 26.5-44.4 seconds - very poor.

  3 days (baseline, mid-intervention, and final assessment)

Other Outcomes (1)

• Occlusion pressures (AOP)

  Baseline

Study Arms (2)

Low-intensity unilateral resistance training group with blood flow restriction

EXPERIMENTAL

This group will perform the training protocol, with the dominant lower limb (LL) executing the exercises using an occlusion cuff set at 40% of total occlusion pressure (TOP), applied continuously throughout the session, while the other limb will perform the exercises without BFR.

Device: Blood Flow Restriction Cuff

Low-intensity bilateral resistance training group without blood flow restriction

NO INTERVENTION

This group will perform the training protocol on both limbs (bilaterally) without the use of blood flow restriction (BFR).

Interventions

Blood Flow Restriction Cuff DEVICE

Inflatable device that exerts an external pressure above a muscle or joint of the extremities.

Low-intensity unilateral resistance training group with blood flow restriction

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Only individuals assigned female at birth will be included, due to physiological characteristics relevant to the study objectives.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly women who present one or more of the following characteristics will not be included:
• a history of stroke, progressive neurological disease, or dementia;
• communication difficulties due to aphasia or hearing loss;
• any health condition that contraindicates or prevents physical exercise;
• a history of hip or knee surgery (e.g., arthroscopy or arthroplasty) or recent lower limb musculoskeletal injury that could impair performance during tests or training (e.g., osteoarthritis, osteoporotic fracture, muscle injury, and/or back pain in the past six months);
• use of supplements aimed at improving physical performance and/or muscle mass; or
• one or more predisposing risk factors for thromboembolism.

You may not qualify if:

• Participants will be excluded from the study if they use medications (analgesics or anti-inflammatory drugs) or other therapeutic interventions that could interfere with any outcomes, or if they sustain an injury resulting from the training and choose to withdraw from the study.

Sponsors & Collaborators

• Paulista University: lead

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

MeSH Terms

Conditions

Hypertrophy; Motor Activity

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 4, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)