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

NCT05744167 | Completed

• 1 other identifier: LithuanianSportsU-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

  Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout

• Changes in blood plasma levels of BDNF

  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

  Before and after the 12 week intervention period

Study Arms (3)

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.

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.

Behavioral: MDRT

Control group

NO INTERVENTION

Control group will be asked to maintain their usual lifestyle.

Interventions

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.

Blood flow restriction training (BFRT)

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.

Muscle damaging resistance training (MDRT)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Lithuanian Sports University

Kaunas, LT 44221, Lithuania

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Nerijus Masiulis, PhD

  Lithuanian Sports University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: February 24, 2023
• Study Start: October 15, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)