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Completed

NCT Number: NCT05744167

Blood Flow Restriction and High-intense Resistance Training in Aging: Interactions Between Neuroplasticity and Muscle

BRAIN-M is a randomized controlled trial designed to examine the effects of a single bout or 12 weeks of blood-flow restriction training or high-intensity resistance training on cognitive function, brain health, muscular properties and physical performance in healthy older men 60-75 years old.

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Key information

Conditions

Aging Atrophy Cognition Disorders Cognitive Decline Cognitive Dysfunction Frailty Mental Disorders Muscle Degeneration Muscular Atrophy Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Disability Sarcopenia Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian Sports University

Kaunas, LT 44221, Lithuania

About this study

The BRAIN-M project is driven by the idea that understanding the mechanisms through which muscle and brain interact could offer new approaches to magnifying the beneficial and detrimental effects of exercise training on health at older age. Specifically, the investigators aim at identifying brain, blood, and muscle biomarkers that could serve as predictors of response to exercise training at either cognitive, brain, muscle or physical performance levels and study the associations between biomarkers in order to suggest a physiological model of brain-muscle and muscle-brain crosstalk in ageing. 60 male older adults (60-75y old) will be included in either 12 weeks of high-intense blood-flow restriction training (n = 20), muscle damaging resistance training (n = 20) or no exercise (n = 20). The control group will be asked to maintain their usual lifestyle.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male older adults
  • able to speak and read fluent Lithuanian
  • living in community during the study

Exclusion criteria

  • cognitive and neurological disorders (e.g. dementia, stroke, Parkinson, multiple sclerosis)
  • previous lower extremity injury
  • diabetes mellitus type I or II
  • no oncologic disease
  • no bone fractures in the previous year
  • deep vein thrombosis
  • cardiovascular disorders (e.g. congestive heart failure, angina pectoris, uncontrolled arrhythmia, history of myocardial infarction or coronary bypass grafting in the past year)
  • obesity (BMI >30kg/m²)
  • chronic fatigue, chronic headache, or chronic dizziness
  • ineligibility to MRI scanning (e.g. due to claustrofobia or metal implants)
  • The participants should not be engaged in any regular exercise programme during the previous 6 months (according to IPAQ), but able to perform 10 sit-ups
  • Any other consideration that interferes with the study aims and/or risk to the participant, at the discretion of the researcher

Treatment and study plan

BFRT

Behavioral

Following a warm-up of 10 min, subjects in the experimental group will undergo BFRT for two times per week, consisting of lower extremity exercises (leg press, knee extension, knee flexion). BFRT will be at 40% of 1 repetition maximum (1RM); The volume % (V% = number of repetitions x number of sets x number of exercises x % 1 repetition max) = 57.6%. Progression during the 12 week program will be attained by a 1RM test every 4 weeks.

MDRT

Behavioral

Following a warm-up of 10 min, subjects in the experimental group will undergo MDRT for two times per week, consisting of lower extremity exercises (leg press, knee extension, knee flexion). The exercise will be at 80% of 1RM concentric-only or 120% of 1RM eccentric-only in a 3:1 ratio. The volume % (V% = number of repetitions x number of sets x number of exercises x % 1 repetition max) = 57.6%. Progression during the 12 week program will be attained by a 1RM test every 4 weeks.

Primary outcomes

  1. Change in cognitive function on the Switching task (executive function)

    Time frame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period

    The switching task is a complex task where subjects need to switch (executive function) between a manikin task (visuospatial skill, attention and problem solving) and a mathematical computation task (mathematical computation skill, concentration and working memory).

Secondary outcomes

  1. Change in cognitive function on the 2-Choice Reaction time (processing speed), Go/No-Go (inhibition) or 6 letter Memory Search (memory) test

    Time frame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period

    Cognitive functioning will be assessed with the Automated Neuropsychological Assessment Metrics 4 (ANAM4) cognitive test battery, testing several cognitive domains.

  2. Changes in lactate levels

    Time frame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout

    Capillary lactate levels will be measured in the acute exercise test.

  3. Changes in blood serum levels of TNFalpha and syndecan

    Time frame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout

    We will use enzyme-linked immunosorbent assays (ELISAs) to measure acute changes in TNFalpha, and syndecan before and after the first exercise bout.

  4. Changes in blood plasma levels of BDNF

    Time frame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period

    We will use enzyme-linked immunosorbent assays (ELISAs) to measure acute and chronic changes in BDNF before and after the first exercise bout; and after 12 weeks intervention

  5. Changes in blood serum levels of IGF-1, IL-6 and kynurenine

    Time frame: Before and after the 12 week intervention period

    We will use enzyme-linked immunosorbent assays (ELISAs) to measure chronic changes in IGF-1, IL-6 and kynurenine before and after 12 weeks intervention

  6. Changes in blood CK levels

    Time frame: Before first exercise bout and every 3 weeks for a total of 7 times 48 hours after the eccentric-only training session in the MDRT group.

    Blood CK levels will be measured in the MDRT group 48 hours after each eccentric-only training session to assess the muscle damaging effect/repeated bout effect.

  7. Changes in muscle contractile characteristics (with tensiomyography (TMG))

    Time frame: Before and after the 12 week intervention period

    Muscle involuntary contractile characteristics of the lower-limb muscles-the rectus femoris (RF), vastus medialis (VM), vastus lateralis (VL), biceps femoris (BF), semitendinosus (ST), tibialis anterior (TA), gastrocnemius medialis (GM) and gastrocnemius lateralis (GL)-will be recorded by measuring the response of these muscles to an induced electric stimulus (provoked by two self-adhesive electrodes) using TMG equipment on both the left and right lower extremities.

  8. Changes in BMI

    Time frame: Before and after the 12 week intervention period

    Weight and height will be combined to report BMI in kg/m^2

  9. Changes in body fat %

    Time frame: Before and after the 12 week intervention period

    body fat % will be measured using bio-impedance analysis (Tanita)

  10. Changes in SMI

    Time frame: Before and after the 12 week intervention period

    Skeletal muscle mass index (SMI, kg/m^2) will be measured using bio-impedance analysis (Tanita)

  11. Changes in fat free mass

    Time frame: Before and after the 12 week intervention period

    Fat free mass (kg) will be measured using bio-impedance analysis (Tanita)

  12. Changes in patellar tendon crossectional area

    Time frame: Before and after the 12 week intervention period

    Ultrasound will be used to assess the crossectional area (cm^2) of the pattella tendon

  13. Changes in patellar tendon stiffness

    Time frame: Before and after the 12 week intervention period

    While producing isometric knee extension force, ultrasound will be used to assess patellar tendon distension, which is a measure of tendon stiffness.

  14. Changes in quadriceps muscle fascicle length

    Time frame: Before and after the 12 week intervention period

    Ultrasound will be used to quantify muscle geometrical properties such as fascicle length (cm).

  15. Changes in quadriceps muscle fascicle angle

    Time frame: Before and after the 12 week intervention period

    Ultrasound will be used to quantify muscle geometrical properties such as fascicle angle (°).

  16. Changes in quadriceps muscle thickness

    Time frame: Before and after the 12 week intervention period

    Ultrasound will be used to quantify muscle geometrical properties such as quadriceps muscle thickness.

  17. Changes in quadriceps muscle cross-sectional area

    Time frame: Before and after the 12 week intervention period

    MRI will be used to measure muscle cross-sectional volume changes of the quadriceps muscles

  18. Changes in quadriceps muscle fiber type

    Time frame: Before and after the 12 week intervention period

    H-MRS (proton magnetic resonance spectroscopy) will be used to measure fiber type in the quadriceps muscle

  19. Changes in quadriceps muscle intramuscular fat

    Time frame: Before and after the 12 week intervention period

    H-MRS (proton magnetic resonance spectroscopy) will be used to measure intramuscular fat in the quadriceps muscle

  20. Changes in brain gray matter volume (with magnetic resonance imaging)

    Time frame: Before and after the 12 week intervention period

    MRI will be used to measure changes in gray matter volume using T1 images

  21. Changes in brain white matter volume (with magnetic resonance imaging)

    Time frame: Before and after the 12 week intervention period

    MRI will be used to measure changes in white matter integrity using DTI sequence

  22. Changes in brain neural integrity (with proton magnetic resonance spectroscopy)

    Time frame: Before and after the 12 week intervention period

    H-MRS will be used to measure changes in N-acetylaspartate levels in specific brain regions: right dorsolateral prefrontal cortex, left hippocampus and left primary sensorimotor cortex.

  23. Changes in brain neuroinflammation (with proton magnetic resonance spectroscopy)

    Time frame: Before and after the 12 week intervention period

    H-MRS will be used to measure changes in myo-inositol levels in specific brain regions: right dorsolateral prefrontal cortex, left hippocampus and left primary sensorimotor cortex.

  24. Changes in brain neuroplasticity marker (with proton magnetic resonance spectroscopy)

    Time frame: Before and after the 12 week intervention period

    H-MRS will be used to measure changes in Glx in specific brain regions: right dorsolateral prefrontal cortex, left hippocampus and left primary sensorimotor cortex.

  25. Changes in balance (with posturography on Kistler platform)

    Time frame: Before and after the 12 week intervention period

    Balance will be assessed in four different positions (two legs stance vs Romberg stance with eyes open vs closed) with or without a cognitive task to measure dual task effects.

  26. Changes in handgrip strength

    Time frame: Before and after the 12 week intervention period

    Handgrip strength will be measured using Jamar dynamometry

  27. Changes in maximal isometric strength (with Biodex)

    Time frame: Before and after the 12 week intervention period

    Knee extension/flexion maximal isometric strength (N) will be measured using Biodex.

  28. Changes in isokinetic peak torque (with Biodex)

    Time frame: Before and after the 12 week intervention period

    Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s

  29. Changes in rate of force development (with Biodex)

    Time frame: Before and after the 12 week intervention period

    Rate of force development will be measured during maximal knee extension/flexion movement.

  30. Changes in physical performance (with the Fitness Fullerton Test battery for the Senior)

    Time frame: Before and after the 12 week intervention period

    Determination of motor control tasks relevant to daily life activities. A selection of tests, including the sit-to-stance test, timed up-and-go test, and other physical tests

  31. Changes in subjective quality of life (patient reported outcome questionnaires)

    Time frame: Before and after the 12 week intervention period

    Quality of life will be assessed using the World Health Organisation 100 (WHO 100) questionnaire

  32. Changes in nutrition (patient reported outcome questionnaires)

    Time frame: Before and after the 12 week intervention period

    We will use a selection of patient reported outcome measures to evaluate their nutrition (using the Actual nutrition registration questionnaire).

  33. Changes in subjective sleep quality (patient reported outcome questionnaires)

    Time frame: Before and after the 12 week intervention period

    We will use a selection of patient reported outcome measures to evaluate their quality of sleep (using the Stanford sleep quality scale).

  34. Changes in reported physical activity levels (patient reported outcome questionnaires)

    Time frame: Before and after the 12 week intervention period

    We will assess physical activity levels using the International Physical Activities Questionnaire (IPAQ)

Sponsors and collaborators

Lead sponsor

Lithuanian Sports University

Other

Collaborators

  • KU Leuven
  • Lithuanian University of Health Sciences
  • Maastricht University
  • Research Council of Lithuania
  • Vrije Universiteit Brussel
  • Wingate Institute

Registry information

Official study title

Resistance Training and Muscle - Brain Crosstalk

Acronym: BRAIN-M

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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