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Clinical Trials/NCT06528951
NCT06528951
Active, not recruiting
Not Applicable

Effects of Different Resistance Training Volumes on Cognitive Function, Oxidative Stress, Inflammatory Markers, Lipid Profile, Glycemic Status, Muscle Damage, Hemodynamic Response, and Physical Performance in Cognitively Impaired Individuals - the TRAIN4BRAIN Study

University of Beira Interior1 site in 1 country69 target enrollmentOctober 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
University of Beira Interior
Enrollment
69
Locations
1
Primary Endpoint
Short Physical Performance Battery
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance in cognitively impaired participants. First, the participants will perform six weeks of resistance training using the same volume for all participants (control phase). The total training volume (sets x repetitions) will be 232 repetitions in the leg press and 160 repetitions in the chest press, with relative intensities ranging from 40% to 70% of 1RM. In week 7, the participants will perform the pre-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance. After the pre-test, the participants will be randomly assigned into two training groups to perform a 10-week intervention. One group will increase the training volume by 15% concerning the training program performed in the control phase, while the other group will increase the volume by 30%. Participants will perform a control test one week after the intervention to assess hemodynamic parameters and physical performance. One week after the control test, the participants will perform another 10-week resistance training program, where the group that performed a volume of 15% will perform 30%, and the group that performed 30% will perform 45%. One week after the intervention, the participants will perform the post-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance. The investigators hypothesize that both training volumes will induce similar adaptations in cognitive function, oxidative stress, immune response, lipid profile, glycemic status, muscle damage, hemodynamics, and physical performance in cognitively impaired individuals.

Detailed Description

Following specific inclusion and exclusion criteria (see Eligibility Criteria), participants will be recruited from residential care facilities or day centers. They will perform two different resistance training volumes with two weekly sessions. The intensity of the exercises, the type and order, movement velocity, and rest time between exercises will be the same in both groups. First, a six-week control phase will be carried out, during which all participants will perform the same resistance training volume (control phase). The total training volume (sets x repetitions) will be 232 repetitions in the leg press and 160 repetitions in the chest press, with relative intensities ranging from 40% to 70% of 1RM. After the control phase, a pre-test will be carried out to evaluate cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, blood pressure, heart rate, Short Physical Performance Battery (SPPB: balance, 4-meter walking, and five-repetition sit-to-stand), medicine ball throw (1Kg), handgrip strength, 1RM leg press, and 1RM chest press. After the pre-test, the participants will be randomly assigned into two groups to perform a 10-week resistance training program with different training volumes: one group will increase the training volume by 15% concerning the training program performed in the control phase, while the other group will increase the volume by 30%. After the 10-week intervention, a control test will be performed to evaluate blood pressure, heart rate, SPPB, medicine ball throw (1 kg), handgrip strength, 1RM leg press, and 1RM chest press. After the control test, the participants will perform another 10-week resistance training program where the group that performed the 15% volume will increase to 30% and the 30% volume to 45%. After the second 10-week intervention program, participants will perform the post-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, blood pressure, heart rate, SPPB, medicine ball throw (1 kg), handgrip strength, 1RM leg press, and 1RM chest press. A control group (without any form of physical exercise), recruited at the beginning of the research project, will also be part of the study. The control group will also undergo a battery of tests before and after the intervention. The outcome measures in the control group will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, and SPPB (balance, 4-meter walking, and five-repetition sit-to-stand).

Registry
clinicaltrials.gov
Start Date
October 28, 2023
End Date
September 29, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Beira Interior
Responsible Party
Principal Investigator
Principal Investigator

Nuno Miguel Pintassilgo da Silva Fonseca

Researcher

University of Beira Interior

Eligibility Criteria

Inclusion Criteria

  • Men or women aged ≥ 50 years old, diagnosed with cognitive impairment (mild, moderate, or severe) through the Dementia Rating Scale-
  • SPPB score ≥
  • Willingness to participate in training programs and collaborate with the research team.
  • Able to provide informed consent (oral or written).

Exclusion Criteria

  • Severe comorbidity that negatively influences participation in the training program.
  • Surgeries or fractures in the last 6 months.
  • Bedridden or hospitalized individuals.

Outcomes

Primary Outcomes

Short Physical Performance Battery

Time Frame: Change from baseline until week 29

The SPPB will determine the overall level of functional performance through three tests: balance (feet side by side, semi-tandem, tandem), 4-meter walking, and 5-repetition sit-to-stand.

Dementia Rating Scale-2 (DRS-2)

Time Frame: Change from baseline until week 29

The DRS-2 questionnaire will be applied to analyze the overall level of cognitive function through five subscales: attention, initiation/perseveration, construction, conceptualization, and memory.

Brain-Derived Neurotrophic Factor (BDNF)

Time Frame: Change from baseline until week 29

The BDNF protein levels will be analyzed through specific blood testing kits.

Secondary Outcomes

  • Systolic blood pressure (SBP)(Change from baseline until week 29)
  • Glycemic status(Change from baseline until week 29)
  • 1-kg Medicine Ball Throw (MBT)(Change from baseline until week 29)
  • Six-minute walking test(Change from baseline until week 29)
  • Load-velocity profiles in the leg press and chest press(Change from baseline until week 29)
  • Diastolic blood pressure (DBP)(Change from baseline until week 29)
  • Heart Rate (HR)(Change from baseline until week 29)
  • Inflammatory markers(Change from baseline until week 29)
  • Muscle damage(Change from baseline until week 29)
  • Handgrip strength (HGS)(Change from baseline until week 29)
  • Ten-meters walking(Change from baseline until week 29)
  • 1RM leg press and chest press(Change from baseline until week 29)
  • Oxidative stress(Change from baseline until week 29)
  • Lipid profile(Change from baseline until week 29)

Study Sites (1)

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