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

August 29, 2024 updated by: Vilma Dudoniene, Lithuanian Sports University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Lithuania
      • Kaunas, Lithuania, LT 44221
        • Recruiting
        • Lithuanian Sports University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blood flow restriction training (BFRT)
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.
Behavioral: BFRT
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.
Experimental: Muscle damaging resistance training (MDRT)
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.
Behavioral: MDRT
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.
No Intervention: Control group
Control group will be asked to maintain their usual lifestyle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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.
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
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
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
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.
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.
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.
Before and after the 12 week intervention period
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
Before and after the 12 week intervention period
Changes in body fat %
Time Frame: Before and after the 12 week intervention period
body fat % will be measured using bio-impedance analysis (Tanita)
Before and after the 12 week intervention period
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)
Before and after the 12 week intervention period
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)
Before and after the 12 week intervention period
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
Before and after the 12 week intervention period
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.
Before and after the 12 week intervention period
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).
Before and after the 12 week intervention period
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 (°).
Before and after the 12 week intervention period
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.
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
MRI will be used to measure muscle cross-sectional volume changes of the quadriceps muscles
Before and after the 12 week intervention period
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
Before and after the 12 week intervention period
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
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
MRI will be used to measure changes in gray matter volume using T1 images
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
MRI will be used to measure changes in white matter integrity using DTI sequence
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
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
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.
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
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
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.
Before and after the 12 week intervention period
Changes in handgrip strength
Time Frame: Before and after the 12 week intervention period
Handgrip strength will be measured using Jamar dynamometry
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
Knee extension/flexion maximal isometric strength (N) will be measured using Biodex.
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
Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s
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
Rate of force development will be measured during maximal knee extension/flexion movement.
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
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
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
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
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
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).
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
We will assess physical activity levels using the International Physical Activities Questionnaire (IPAQ)
Before and after the 12 week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lithuanian Sports University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KU Leuven
Lithuanian University of Health Sciences
Wingate Institute
Maastricht University
Vrije Universiteit Brussel
Research Council of Lithuania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nerijus Masiulis, PhD, Lithuanian Sports University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LithuanianSportsU-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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