AgingBRAIN-MNCT05744167
Blood Flow Restriction and High-intense Resistance Training in Aging: Interactions Between Neuroplasticity and Muscle
A study testing BFRT and MDRT in people with Aging and Cognitive Decline, run by Lithuanian Sports University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Decline, Sarcopenia
- What is being tested?
- BFRT and MDRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Oct 2022to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male older adults
- able to speak and read fluent Lithuanian
- living in community during the study
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the 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.
- Conditions
- Aging, Cognitive Decline, Sarcopenia, Frailty, Muscle Degeneration, Physical Disability
- Being tested
- BFRT, MDRT
- Keywords
- Aging, Motor control, Cognitive function, Neuroplasticity, Brain health, Muscular fitness, Exerkines, Myokines, (Neuro)inflammation
- Medical subject headings
- Cognitive Dysfunction, Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRTBehavioural
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.
MDRTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction training (BFRT) | Experimental | Participants will engage in a supervised 12-week lower extremity resistance exercise program, 2 times per week. BFRT will be at an intensity of 40% of 1RM with an occlusive cuff placed at the proximal end of both lower extremities to restrict the return of blood flow. The cuff will be inflated to 50% of the limb occlusion pressure in the first week, which will be increased with 10% every week during the first 4 weeks to reach a maximum of 80% limb occlusion pressure on week 4 that will be kept for the remaining 9 weeks of the program. Each exercise will be performed for 4 sets of 12 repetitions with a 30-second rest period between sets and 3 minutes rest between exercises without occlusion. Receives: Behavioral: BFRT |
| Muscle damaging resistance training (MDRT) | Experimental | Participants will engage in a supervised 12-week lower extremity resistance exercise program, 2 times per week. MDRT will be at an intensity of 80% or 120% of 1RM. The first session will be at 120% 1RM and consist of eccentric-only exercises. The concentric phase of the movement will be supported completely by a coach. The eccentric phase of the movement will be accentuated by increasing the time under tension to six seconds. Each exercise will be performed for 4 sets of 4 repetitions with 2 minutes rest between sets and 3 minutes rest between exercises. The eccentric-only exercise session will be followed by 2 (after the first session) or 3 (after all other sessions) concentric-only exercise sessions at 80% of 1RM. Here, the eccentric phase of the movement will be supported completely by a coach. In the 12 week period, there will be a total of seven eccentric-only exercise sessions. Receives: Behavioral: MDRT |
| Control group | No intervention | Control group will be asked to maintain their usual lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (34)
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.
Measured: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period
Changes in lactate levels
Capillary lactate levels will be measured in the acute exercise test.
Measured: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout
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.
Measured: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout
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
Measured: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period
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
Measured: Before and after the 12 week intervention period
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.
Measured: 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.
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.
Measured: Before and after the 12 week intervention period
Changes in BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: Before and after the 12 week intervention period
Changes in body fat %
body fat % will be measured using bio-impedance analysis (Tanita)
Measured: Before and after the 12 week intervention period
Changes in SMI
Skeletal muscle mass index (SMI, kg/m^2) will be measured using bio-impedance analysis (Tanita)
Measured: Before and after the 12 week intervention period
Changes in fat free mass
Fat free mass (kg) will be measured using bio-impedance analysis (Tanita)
Measured: Before and after the 12 week intervention period
Changes in patellar tendon crossectional area
Ultrasound will be used to assess the crossectional area (cm^2) of the pattella tendon
Measured: Before and after the 12 week intervention period
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.
Measured: Before and after the 12 week intervention period
Changes in quadriceps muscle fascicle length
Ultrasound will be used to quantify muscle geometrical properties such as fascicle length (cm).
Measured: Before and after the 12 week intervention period
Changes in quadriceps muscle fascicle angle
Ultrasound will be used to quantify muscle geometrical properties such as fascicle angle (°).
Measured: Before and after the 12 week intervention period
Changes in quadriceps muscle thickness
Ultrasound will be used to quantify muscle geometrical properties such as quadriceps muscle thickness.
Measured: Before and after the 12 week intervention period
Changes in quadriceps muscle cross-sectional area
MRI will be used to measure muscle cross-sectional volume changes of the quadriceps muscles
Measured: Before and after the 12 week intervention period
Changes in quadriceps muscle fiber type
H-MRS (proton magnetic resonance spectroscopy) will be used to measure fiber type in the quadriceps muscle
Measured: Before and after the 12 week intervention period
Changes in quadriceps muscle intramuscular fat
H-MRS (proton magnetic resonance spectroscopy) will be used to measure intramuscular fat in the quadriceps muscle
Measured: Before and after the 12 week intervention period
Changes in brain gray matter volume (with magnetic resonance imaging)
MRI will be used to measure changes in gray matter volume using T1 images
Measured: Before and after the 12 week intervention period
Changes in brain white matter volume (with magnetic resonance imaging)
MRI will be used to measure changes in white matter integrity using DTI sequence
Measured: Before and after the 12 week intervention period
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.
Measured: Before and after the 12 week intervention period
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.
Measured: Before and after the 12 week intervention period
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.
Measured: Before and after the 12 week intervention period
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.
Measured: Before and after the 12 week intervention period
Changes in handgrip strength
Handgrip strength will be measured using Jamar dynamometry
Measured: Before and after the 12 week intervention period
Changes in maximal isometric strength (with Biodex)
Knee extension/flexion maximal isometric strength (N) will be measured using Biodex.
Measured: Before and after the 12 week intervention period
Changes in isokinetic peak torque (with Biodex)
Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s
Measured: Before and after the 12 week intervention period
Changes in rate of force development (with Biodex)
Rate of force development will be measured during maximal knee extension/flexion movement.
Measured: Before and after the 12 week intervention period
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
Measured: Before and after the 12 week intervention period
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
Measured: Before and after the 12 week intervention period
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).
Measured: Before and after the 12 week intervention period
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).
Measured: Before and after the 12 week intervention period
Changes in reported physical activity levels (patient reported outcome questionnaires)
We will assess physical activity levels using the International Physical Activities Questionnaire (IPAQ)
Measured: Before and after the 12 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start15 Oct 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Council of Lithuania, Lithuanian University of Health Sciences, Maastricht University, Vrije Universiteit Brussel, KU Leuven, Wingate Institute
- Responsible party
- Principal investigator, Vilma Dudoniene, Lithuanian Sports University
- Investigators
- Nerijus Masiulis, PhD, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744167
- Sponsor's protocol ID
- LithuanianSportsU-11
- Acronym
- BRAIN-M
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2022
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cesanelli L, Dranevicius G, Mickevicius M, Satkunskiene D, Muanjai P, Cesnaitiene VJ, Levin O, Vints W, Masiulis N, Kamandulis S. Effects of high-intensity and blood-flow-restricted resistance training on tendon adaptations in older men. Eur J Appl Physiol. 2026 Aug;126(8):4495-4506. doi: 10.1007/s00421-026-06255-0. Epub 2026 May 26.
PubMed 42191902
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training and Muscle - Brain Crosstalk
- ClinicalTrials.gov ID
- NCT05744167
- Acronym / sponsor ID
- BRAIN-M / LithuanianSportsU-11
- Conditions
- Aging, Cognitive Decline, Sarcopenia, Frailty, Muscle Degeneration, Physical Disability
- Keywords
- Aging, Motor control, Cognitive function, Neuroplasticity, Brain health, Muscular fitness, Exerkines, Myokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Collaborators
- Research Council of Lithuania, Lithuanian University of Health Sciences, Maastricht University, Vrije Universiteit Brussel, KU Leuven, Wingate Institute
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction training (BFRT) | Experimental | Behavioral: BFRTParticipants will engage in a supervised 12-week lower extremity resistance exercise program, 2 times per week. BFRT will be at an intensity of 40% of 1RM with an occlusive cuff placed at the proximal end of both lower extremities to restrict the return of blood flow. The cuff will be inflated to 50% of the limb occlusion pressure in the first week, which will be increased with 10% every week during the first 4 weeks to reach a maximum of 80% limb occlusion pressure on week 4 that will be kept for the remaining 9 weeks of the program. Each exercise will be performed for 4 sets of 12 repetitions with a 30-second rest period between sets and 3 minutes rest between exercises without occlusion. |
| Muscle damaging resistance training (MDRT) | Experimental | Behavioral: MDRTParticipants will engage in a supervised 12-week lower extremity resistance exercise program, 2 times per week. MDRT will be at an intensity of 80% or 120% of 1RM. The first session will be at 120% 1RM and consist of eccentric-only exercises. The concentric phase of the movement will be supported completely by a coach. The eccentric phase of the movement will be accentuated by increasing the time under tension to six seconds. Each exercise will be performed for 4 sets of 4 repetitions with 2 minutes rest between sets and 3 minutes rest between exercises. The eccentric-only exercise session will be followed by 2 (after the first session) or 3 (after all other sessions) concentric-only exercise sessions at 80% of 1RM. Here, the eccentric phase of the movement will be supported completely by a coach. In the 12 week period, there will be a total of seven eccentric-only exercise sessions. |
| Control group | No intervention | –Control group will be asked to maintain their usual lifestyle. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy male older adults
- able to speak and read fluent Lithuanian
- living in community during the study
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFRTFollowing 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. | Behavioural | Blood flow restriction training (BFRT) |
| MDRTFollowing 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. | Behavioural | Muscle damaging resistance training (MDRT) |
Primary outcome
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).
34 secondary outcomes
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
Changes in lactate levels
Time frame: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout
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
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
Changes in blood serum levels of IGF-1, IL-6 and kynurenine
Time frame: Before and after the 12 week intervention period
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.
Changes in muscle contractile characteristics (with tensiomyography (TMG))
Time frame: Before and after the 12 week intervention period
Changes in BMI
Time frame: Before and after the 12 week intervention period
Changes in body fat %
Time frame: Before and after the 12 week intervention period
Changes in SMI
Time frame: Before and after the 12 week intervention period
Changes in fat free mass
Time frame: Before and after the 12 week intervention period
Changes in patellar tendon crossectional area
Time frame: Before and after the 12 week intervention period
Changes in patellar tendon stiffness
Time frame: Before and after the 12 week intervention period
Changes in quadriceps muscle fascicle length
Time frame: Before and after the 12 week intervention period
Changes in quadriceps muscle fascicle angle
Time frame: Before and after the 12 week intervention period
Changes in quadriceps muscle thickness
Time frame: Before and after the 12 week intervention period
Changes in quadriceps muscle cross-sectional area
Time frame: Before and after the 12 week intervention period
Changes in quadriceps muscle fiber type
Time frame: Before and after the 12 week intervention period
Changes in quadriceps muscle intramuscular fat
Time frame: Before and after the 12 week intervention period
Changes in brain gray matter volume (with magnetic resonance imaging)
Time frame: Before and after the 12 week intervention period
Changes in brain white matter volume (with magnetic resonance imaging)
Time frame: Before and after the 12 week intervention period
Changes in brain neural integrity (with proton magnetic resonance spectroscopy)
Time frame: Before and after the 12 week intervention period
Changes in brain neuroinflammation (with proton magnetic resonance spectroscopy)
Time frame: Before and after the 12 week intervention period
Changes in brain neuroplasticity marker (with proton magnetic resonance spectroscopy)
Time frame: Before and after the 12 week intervention period
Changes in balance (with posturography on Kistler platform)
Time frame: Before and after the 12 week intervention period
Changes in handgrip strength
Time frame: Before and after the 12 week intervention period
Changes in maximal isometric strength (with Biodex)
Time frame: Before and after the 12 week intervention period
Changes in isokinetic peak torque (with Biodex)
Time frame: Before and after the 12 week intervention period
Changes in rate of force development (with Biodex)
Time frame: Before and after the 12 week intervention period
Changes in physical performance (with the Fitness Fullerton Test battery for the Senior)
Time frame: Before and after the 12 week intervention period
Changes in subjective quality of life (patient reported outcome questionnaires)
Time frame: Before and after the 12 week intervention period
Changes in nutrition (patient reported outcome questionnaires)
Time frame: Before and after the 12 week intervention period
Changes in subjective sleep quality (patient reported outcome questionnaires)
Time frame: Before and after the 12 week intervention period
Changes in reported physical activity levels (patient reported outcome questionnaires)
Time frame: Before and after the 12 week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Derived from this study: PubMed 42191902Cesanelli L, Dranevicius G, Mickevicius M, Satkunskiene D, Muanjai P, Cesnaitiene VJ, Levin O, Vints W, Masiulis N, Kamandulis S. Effects of high-intensity and blood-flow-restricted resistance training on tendon adaptations in older men. Eur J Appl Physiol. 2026 Aug;126(8):4495-4506. doi: 10.1007/s00421-026-06255-0. Epub 2026 May 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nerijus Masiulis, PhD principal investigator
Lithuanian Sports University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFRT and MDRT in people with Aging and Cognitive Decline, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.