Aging Clinical Trial
— BRAIN-MOfficial title:
Resistance Training and Muscle - Brain Crosstalk
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 31, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 60 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Lithuania | Lithuanian Sports University | Kaunas |
Lead Sponsor | Collaborator |
---|---|
Lithuanian Sports University | KU Leuven, Lithuanian University of Health Sciences, Maastricht University, Research Council of Lithuania, Vrije Universiteit Brussel, Wingate Institute |
Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cognitive function on the Switching task (executive function) | 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). | Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period | |
Secondary | Change in cognitive function on the 2-Choice Reaction time (processing speed), Go/No-Go (inhibition) or 6 letter Memory Search (memory) test | Cognitive functioning will be assessed with the Automated Neuropsychological Assessment Metrics 4 (ANAM4) cognitive test battery, testing several cognitive domains. | Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period | |
Secondary | Changes in lactate levels | Capillary lactate levels will be measured in the acute exercise test. | Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout | |
Secondary | Changes in blood serum levels of TNFalpha and syndecan | We will use enzyme-linked immunosorbent assays (ELISAs) to measure acute changes in TNFalpha, and syndecan before and after the first exercise bout. | Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout | |
Secondary | Changes in blood plasma levels of BDNF | 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 | Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period | |
Secondary | Changes in blood serum levels of IGF-1, IL-6 and kynurenine | 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 | Before and after the 12 week intervention period | |
Secondary | Changes in blood CK levels | 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. | 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. | |
Secondary | Changes in muscle contractile characteristics (with tensiomyography (TMG)) | 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. | Before and after the 12 week intervention period | |
Secondary | Changes in BMI | Weight and height will be combined to report BMI in kg/m^2 | Before and after the 12 week intervention period | |
Secondary | Changes in body fat % | body fat % will be measured using bio-impedance analysis (Tanita) | Before and after the 12 week intervention period | |
Secondary | Changes in SMI | Skeletal muscle mass index (SMI, kg/m^2) will be measured using bio-impedance analysis (Tanita) | Before and after the 12 week intervention period | |
Secondary | Changes in fat free mass | Fat free mass (kg) will be measured using bio-impedance analysis (Tanita) | Before and after the 12 week intervention period | |
Secondary | Changes in patellar tendon crossectional area | Ultrasound will be used to assess the crossectional area (cm^2) of the pattella tendon | Before and after the 12 week intervention period | |
Secondary | Changes in patellar tendon stiffness | While producing isometric knee extension force, ultrasound will be used to assess patellar tendon distension, which is a measure of tendon stiffness. | Before and after the 12 week intervention period | |
Secondary | Changes in quadriceps muscle fascicle length | Ultrasound will be used to quantify muscle geometrical properties such as fascicle length (cm). | Before and after the 12 week intervention period | |
Secondary | Changes in quadriceps muscle fascicle angle | Ultrasound will be used to quantify muscle geometrical properties such as fascicle angle (°). | Before and after the 12 week intervention period | |
Secondary | Changes in quadriceps muscle thickness | Ultrasound will be used to quantify muscle geometrical properties such as quadriceps muscle thickness. | Before and after the 12 week intervention period | |
Secondary | Changes in quadriceps muscle cross-sectional area | MRI will be used to measure muscle cross-sectional volume changes of the quadriceps muscles | Before and after the 12 week intervention period | |
Secondary | Changes in quadriceps muscle fiber type | H-MRS (proton magnetic resonance spectroscopy) will be used to measure fiber type in the quadriceps muscle | Before and after the 12 week intervention period | |
Secondary | Changes in quadriceps muscle intramuscular fat | H-MRS (proton magnetic resonance spectroscopy) will be used to measure intramuscular fat in the quadriceps muscle | Before and after the 12 week intervention period | |
Secondary | Changes in brain gray matter volume (with magnetic resonance imaging) | MRI will be used to measure changes in gray matter volume using T1 images | Before and after the 12 week intervention period | |
Secondary | Changes in brain white matter volume (with magnetic resonance imaging) | MRI will be used to measure changes in white matter integrity using DTI sequence | Before and after the 12 week intervention period | |
Secondary | Changes in brain neural integrity (with proton magnetic resonance spectroscopy) | 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. | Before and after the 12 week intervention period | |
Secondary | Changes in brain neuroinflammation (with proton magnetic resonance spectroscopy) | 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. | Before and after the 12 week intervention period | |
Secondary | Changes in brain neuroplasticity marker (with proton magnetic resonance spectroscopy) | 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. | Before and after the 12 week intervention period | |
Secondary | Changes in balance (with posturography on Kistler platform) | 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. | Before and after the 12 week intervention period | |
Secondary | Changes in handgrip strength | Handgrip strength will be measured using Jamar dynamometry | Before and after the 12 week intervention period | |
Secondary | Changes in maximal isometric strength (with Biodex) | Knee extension/flexion maximal isometric strength (N) will be measured using Biodex. | Before and after the 12 week intervention period | |
Secondary | Changes in isokinetic peak torque (with Biodex) | Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s | Before and after the 12 week intervention period | |
Secondary | Changes in rate of force development (with Biodex) | Rate of force development will be measured during maximal knee extension/flexion movement. | Before and after the 12 week intervention period | |
Secondary | Changes in physical performance (with the Fitness Fullerton Test battery for the Senior) | 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 | Before and after the 12 week intervention period | |
Secondary | Changes in subjective quality of life (patient reported outcome questionnaires) | Quality of life will be assessed using the World Health Organisation 100 (WHO 100) questionnaire | Before and after the 12 week intervention period | |
Secondary | Changes in nutrition (patient reported outcome questionnaires) | We will use a selection of patient reported outcome measures to evaluate their nutrition (using the Actual nutrition registration questionnaire). | Before and after the 12 week intervention period | |
Secondary | Changes in subjective sleep quality (patient reported outcome questionnaires) | We will use a selection of patient reported outcome measures to evaluate their quality of sleep (using the Stanford sleep quality scale). | Before and after the 12 week intervention period | |
Secondary | Changes in reported physical activity levels (patient reported outcome questionnaires) | We will assess physical activity levels using the International Physical Activities Questionnaire (IPAQ) | Before and after the 12 week intervention period |
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