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

NCT ID: NCT05744167

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-11-17

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.

Conditions

Aging; Cognitive Decline; Sarcopenia; Frailty; Muscle Degeneration; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

BFRT

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

MDRT

Intervention Type: 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.

Control group

Control group will be asked to maintain their usual lifestyle.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Research Council of Lithuania

OTHER

Sponsor Role: collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role: collaborator

Maastricht University

OTHER

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Wingate Institute

OTHER

Sponsor Role: collaborator

Lithuanian Sports University

OTHER

Sponsor Role: lead

Responsible Party

Vilma Dudoniene

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nerijus Masiulis, PhD

Role: PRINCIPAL_INVESTIGATOR

Lithuanian Sports University

Locations

Lithuanian Sports University

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

LithuanianSportsU-11

Identifier Type: -

Identifier Source: org_study_id