Clinical trial NCT06528951: Impact of Resistance Training Volume on Cognitive Function and Physical Performance in Cognitively Impaired Individuals
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Keywords: Dementia
Physical exercise
Volume
Functional performance
Healthy aging
Lead sponsor: University of Beira Interior
Sponsor class: OTHER
Collaborators: name: Research Center in Sports Sciences, Health Sciences and Human Development
First posted: 2024-07-30
Enrollment: 69
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Men or women aged ≥ 50 years old, diagnosed with cognitive impairment (mild, moderate, or severe) through the Dementia Rating Scale-2.
* SPPB score ≥ 3.
* 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.

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: Change from baseline until week 29
measure: Dementia Rating Scale-2 (DRS-2)
timeFrame: Change from baseline until week 29
measure: Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: Change from baseline until week 29
Secondary outcomes:
measure: 1-kg Medicine Ball Throw (MBT)
timeFrame: Change from baseline until week 29
measure: Handgrip strength (HGS)
timeFrame: Change from baseline until week 29
measure: Ten-meters walking
timeFrame: Change from baseline until week 29
measure: 1RM leg press and chest press
timeFrame: Change from baseline until week 29
measure: Six-minute walking test
timeFrame: Change from baseline until week 29
measure: Load-velocity profiles in the leg press and chest press
timeFrame: Change from baseline until week 29
measure: Systolic blood pressure (SBP)
timeFrame: Change from baseline until week 29
measure: Diastolic blood pressure (DBP)
timeFrame: Change from baseline until week 29
measure: Heart Rate (HR)
timeFrame: Change from baseline until week 29
measure: Oxidative stress
timeFrame: Change from baseline until week 29
measure: Inflammatory markers
timeFrame: Change from baseline until week 29
measure: Lipid profile
timeFrame: Change from baseline until week 29
measure: Glycemic status
timeFrame: Change from baseline until week 29
measure: Muscle damage
timeFrame: Change from baseline until week 29
Other outcomes:
Locations:
city: Covilhã
country: Portugal
facility: University of Beira Interior
Study officials:
affiliation: University of Beira Interior
name: Mário M; Marques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Beira Interior
name: Dulce Esteves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Pública de Navarra
name: Mikel Izquierdo, PhD
role: PRINCIPAL_INVESTIGATOR
References: