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Clinical Trials/NCT06185010
NCT06185010
Recruiting
Not Applicable

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

University of Beira Interior1 site in 1 country80 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
University of Beira Interior
Enrollment
80
Locations
1
Primary Endpoint
Short Physical Performance Battery (SPPB)
Status
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, 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
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

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Short Physical Performance Battery (SPPB)

Time Frame: Change from baseline until week 8

In the eight-week study, 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.

Systolic blood pressure (SBP)

Time Frame: Change from baseline to 0 minutes and 72 hours after the sessions

In the cross-over study (acute effects), the SBP will be assessed through a blood pressure device.

Handgrip strength (HGS)

Time Frame: Change from baseline to 0 minutes and 72 hours after the sessions

In the cross-over study (acute effects), the HGS will be assessed through an analogic dynamometer.

Dementia Rating Scale-2 (DRS-2)

Time Frame: Change from baseline to week 8

In the eight-week study, 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 to week 8

In the eight-week study, the BDNF protein levels will be analyzed through specific blood testing kits.

Secondary Outcomes

  • Five-repetition sit-to-stand (5STS)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • Oxidative stress(Change from baseline to week 8)
  • Lipid Profile(Change from baseline to week 8)
  • Load-velocity profiles(Change from baseline to week 8)
  • Diastolic blood pressure (DBP)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • Heart rate (HR)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • Tympanic temperature (TT)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • 1-kg Medicine Ball Throw (MBT)(Change from baseline to week 8)
  • Inflammatory markers(Change from baseline to week 8)
  • HbA1c(Change from baseline to week 8)
  • Ten-meters walking(Change from baseline to week 8)
  • Muscle Damage(Change from baseline to week 8)
  • One-repetition maximum (1RM)(Change from baseline to week 8)
  • Handgrip strength (HGS)(Change from baseline to week 8)
  • 6-Minute Walk Test (6MWT)(Change from baseline to week 8)

Study Sites (1)

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