Clinical trial NCT06185010: Resistance Training to Individuals for Cognitive Impairment With Dementia
Official title: Effects of Different Resistance Training Volumes on Cognitive Function, Oxidative Stress, Immunological Response, Lipid Profile, Glycemic Status, Liver Function, Muscle Function, Hemodynamic Response, and Physical Performance in Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Lead sponsor: University of Beira Interior
Sponsor class: OTHER
Collaborators: name: Research Center in Sports Sciences, Health Sciences and Human Development
First posted: 2023-12-29
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. First the investigators will analyze the effects of a single resistance training session (acute effects) with one and three sets on hemodynamic and physical performance in individuals with mild cognitive impairment. After, the investigators will analyze the effects of an 8-week resistance training program with one or three sets on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. The investigators hypothesize that a single resistance training session of one or three sets will increase the acute hemodynamic and physical performance stress in individuals with mild cognitive impairment, although with a higher magnitude in the session with three sets. Furthermore, we hypothesize that eight weeks of resistance training with one or three sets will induce similar improvements in cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment.

Detailed description: Following specific inclusion and exclusion criteria (see Eligibility Criteria), participants will be recruited from residential care facilities or day centers. For the acute effects study (cross-over study), participants will randomly perform two resistance training sessions separated by one week of rest: i) one session with one set and ii) another session of three sets. The intensity of the exercises, number of repetitions, type and order of exercises, movement velocity, and rest time between exercises will be the same in both groups. Before, immediately after, and 72 hours after the sessions, a battery of tests will be applied to evaluate the changes in blood pressure, heart rate, tympanic temperature, medicine ball throw distance, five-repetition sit-to-stand time, and handgrip strength. Afterward, participants will be randomly assigned into a one-set or three-set group to perform an eight-week resistance training intervention. As for the acute effects study, the prescription of the other acute training variables will be the same for both groups. A control group (without any form of physical exercise), recruited at the beginning of the research project, will also be part of the study. Before and after the intervention, a battery of tests will be applied to determine the training program's impact on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment.

Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of mild cognitive impairment
* SPPB score ≥ 3 points
* Willingness to participate in the interventions and collaborate with the research team
* Must be able to provide informed consent (oral or written)

Exclusion criteria:

* Severe dementia
* Severe comorbidity that negatively influences participation in the intervention
* Color blindness
* Fractures in the last three months

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: Change from baseline to 0 minutes and 72 hours after the sessions
measure: Handgrip strength (HGS)
timeFrame: Change from baseline to 0 minutes and 72 hours after the sessions
measure: Dementia Rating Scale-2 (DRS-2)
timeFrame: Change from baseline to week 8
measure: Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: Change from baseline to week 8
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from baseline until week 8
Secondary outcomes:
measure: Diastolic blood pressure (DBP)
timeFrame: Change from baseline to 0 minutes and 72 hours after the sessions
measure: Heart rate (HR)
timeFrame: Change from baseline to 0 minutes and 72 hours after the sessions
measure: Tympanic temperature (TT)
timeFrame: Change from baseline to 0 minutes and 72 hours after the sessions
measure: Five-repetition sit-to-stand (5STS)
timeFrame: Change from baseline to 0 minutes and 72 hours after the sessions
measure: 1-kg Medicine Ball Throw (MBT)
timeFrame: Change from baseline to 0 minutes and 72 hours after the sessions
measure: Inflammatory markers
timeFrame: Change from baseline to week 8
measure: Oxidative stress
timeFrame: Change from baseline to week 8
measure: Lipid Profile
timeFrame: Change from baseline to week 8
measure: HbA1c
timeFrame: Change from baseline to week 8
measure: Muscle Damage
timeFrame: Change from baseline to week 8
measure: One-repetition maximum (1RM)
timeFrame: Change from baseline to week 8
measure: Load-velocity profiles
timeFrame: Change from baseline to week 8
measure: Ten-meters walking
timeFrame: Change from baseline to week 8
measure: 1-kg Medicine Ball Throw (MBT)
timeFrame: Change from baseline to week 8
measure: Handgrip strength (HGS)
timeFrame: Change from baseline to week 8
measure: 6-Minute Walk Test (6MWT)
timeFrame: Change from baseline to week 8
Other outcomes:
Locations:
city: Covilhã
country: Portugal
facility: University of Beira Interior
Study officials:
affiliation: University of Beira Interior
name: Mário C 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: