Clinical trial NCT05744167: Blood Flow Restriction and High-intense Resistance Training in Aging: Interactions Between Neuroplasticity and Muscle
Official title: Resistance Training and Muscle - Brain Crosstalk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cognitive Decline
Sarcopenia
Frailty
Muscle Degeneration
Physical Disability
Keywords: Aging
Motor control
Cognitive function
Neuroplasticity
Brain health
Muscular fitness
Exerkines
Myokines
(Neuro)inflammation
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
Collaborators: name: Research Council of Lithuania
name: Lithuanian University of Health Sciences
name: Maastricht University
name: Vrije Universiteit Brussel
name: KU Leuven
name: Wingate Institute
First posted: 2023-02-24
Enrollment: 60
Sex: MALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive function on the Switching task (executive function)
timeFrame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period
Secondary outcomes:
measure: Change in cognitive function on the 2-Choice Reaction time (processing speed), Go/No-Go (inhibition) or 6 letter Memory Search (memory) test
timeFrame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period
measure: Changes in lactate levels
timeFrame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout
measure: Changes in blood serum levels of TNFalpha and syndecan
timeFrame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout
measure: Changes in blood plasma levels of BDNF
timeFrame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period
measure: Changes in blood serum levels of IGF-1, IL-6 and kynurenine
timeFrame: Before and after the 12 week intervention period
measure: Changes in blood CK levels
timeFrame: 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.
measure: Changes in muscle contractile characteristics (with tensiomyography (TMG))
timeFrame: Before and after the 12 week intervention period
measure: Changes in BMI
timeFrame: Before and after the 12 week intervention period
measure: Changes in body fat %
timeFrame: Before and after the 12 week intervention period
measure: Changes in SMI
timeFrame: Before and after the 12 week intervention period
measure: Changes in fat free mass
timeFrame: Before and after the 12 week intervention period
measure: Changes in patellar tendon crossectional area
timeFrame: Before and after the 12 week intervention period
measure: Changes in patellar tendon stiffness
timeFrame: Before and after the 12 week intervention period
measure: Changes in quadriceps muscle fascicle length
timeFrame: Before and after the 12 week intervention period
measure: Changes in quadriceps muscle fascicle angle
timeFrame: Before and after the 12 week intervention period
measure: Changes in quadriceps muscle thickness
timeFrame: Before and after the 12 week intervention period
measure: Changes in quadriceps muscle cross-sectional area
timeFrame: Before and after the 12 week intervention period
measure: Changes in quadriceps muscle fiber type
timeFrame: Before and after the 12 week intervention period
measure: Changes in quadriceps muscle intramuscular fat
timeFrame: Before and after the 12 week intervention period
measure: Changes in brain gray matter volume (with magnetic resonance imaging)
timeFrame: Before and after the 12 week intervention period
measure: Changes in brain white matter volume (with magnetic resonance imaging)
timeFrame: Before and after the 12 week intervention period
measure: Changes in brain neural integrity (with proton magnetic resonance spectroscopy)
timeFrame: Before and after the 12 week intervention period
measure: Changes in brain neuroinflammation (with proton magnetic resonance spectroscopy)
timeFrame: Before and after the 12 week intervention period
measure: Changes in brain neuroplasticity marker (with proton magnetic resonance spectroscopy)
timeFrame: Before and after the 12 week intervention period
measure: Changes in balance (with posturography on Kistler platform)
timeFrame: Before and after the 12 week intervention period
measure: Changes in handgrip strength
timeFrame: Before and after the 12 week intervention period
measure: Changes in maximal isometric strength (with Biodex)
timeFrame: Before and after the 12 week intervention period
measure: Changes in isokinetic peak torque (with Biodex)
timeFrame: Before and after the 12 week intervention period
measure: Changes in rate of force development (with Biodex)
timeFrame: Before and after the 12 week intervention period
measure: Changes in physical performance (with the Fitness Fullerton Test battery for the Senior)
timeFrame: Before and after the 12 week intervention period
measure: Changes in subjective quality of life (patient reported outcome questionnaires)
timeFrame: Before and after the 12 week intervention period
measure: Changes in nutrition (patient reported outcome questionnaires)
timeFrame: Before and after the 12 week intervention period
measure: Changes in subjective sleep quality (patient reported outcome questionnaires)
timeFrame: Before and after the 12 week intervention period
measure: Changes in reported physical activity levels (patient reported outcome questionnaires)
timeFrame: Before and after the 12 week intervention period
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
affiliation: Lithuanian Sports University
name: Nerijus Masiulis, PhD
role: PRINCIPAL_INVESTIGATOR
References: