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NCT Number: NCT06185010

Resistance Training to Individuals for Cognitive Impairment With Dementia

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Dementia Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Beira Interior

Covilha, Portugal

Location status: Recruiting

Location contact

Nuno Fonseca

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One Resistance Training Set (Single Session)

Other

The participants will perform a resistance training session with one set per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 1 set of 10 repetitions at 60% of one-repetition maximum (1RM) in the leg press, iii) 1 set of 10 repetitions at 55% 1RM in the chest press, iv) 1 set of 10 repetitions in the sit-to-stand exercise, v) 1 set of 10 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Three Resistance Training Sets (Single Session)

Other

The participants will perform a resistance training session with three sets per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 3 sets of 10 repetitions at 60% of one-repetition maximum (1RM) in the leg press, iii) 3 sets of 10 repetitions at 55% 1RM in the chest press, iv) 3 sets of 10 repetitions in the sit-to-stand exercise, v) 3 sets of 10 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

One Resistance Training Set (8 Weeks)

Other

The participants will perform eight weeks of resistance training with one set per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 1 set of 10 repetitions between 50-70% of one-repetition maximum (1RM) in the leg press, iii) 1 set of 10 repetitions between 40-60% 1RM in the chest press, iv) 1 set of 6-12 repetitions in the sit-to-stand exercise, v) 1 set of 6-12 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Three Resistance Training Sets (8 Weeks)

Other

The participants will perform eight weeks of resistance training with three sets per exercise. The training sequence will be the following: i) 10 minutes of warm-up walking on the treadmill at 50% of maximal walking velocity, ii) 3 sets of 10 repetitions between 50-70% of one-repetition maximum (1RM) in the leg press, iii) 3 sets of 10 repetitions between 40-60% 1RM in the chest press, iv) 3 sets of 6-12 repetitions in the sit-to-stand exercise, v) 3 sets of 6-12 repetitions in the 1-kg medicine ball throw exercise, and vi) 5 minutes walking on the treadmill at 60% of maximal walking velocity.

Control (8 Weeks)

Other

The participants in the control group will maintain their regular daily activities without performing any form of physical exercise.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Diastolic blood pressure (DBP)

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

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

  2. Heart rate (HR)

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

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

  3. Tympanic temperature (TT)

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

    In the cross-over study (acute effects), the TT will be assessed through a tympanic thermometer.

  4. Five-repetition sit-to-stand (5STS)

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

    In the cross-over study (acute effects), the 5STS time will be recorded through a chronometer.

  5. 1-kg Medicine Ball Throw (MBT)

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

    In the cross-over study (acute effects), the MBT distance will be recorded with a tape measure.

  6. Inflammatory markers

    Time frame: Change from baseline to week 8

    In the eight-week study, inflammatory markers (IL-6, TNF-α, and IL-10) will be analyzed through specific blood testing kits.

  7. Oxidative stress

    Time frame: Change from baseline to week 8

    In the eight-week study, oxidative stress markers (carbonylated proteins) will be analyzed through specific blood testing kits.

  8. Lipid Profile

    Time frame: Change from baseline to week 8

    In the eight-week study, the lipid profile (LDL, HDL, total cholesterol, triglycerides) will be analyzed through specific blood testing kits.

  9. HbA1c

    Time frame: Change from baseline to week 8

    In the eight-week study, the HbA1c will be analyzed through specific blood testing kits.

  10. Muscle Damage

    Time frame: Change from baseline to week 8

    In the eight-week study, the muscle damage (creatine kinase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase) will be analyzed through specific blood testing kits.

  11. One-repetition maximum (1RM)

    Time frame: Change from baseline to week 8

    In the eight-week study, a progressive loading test until reaching the 1RM will be applied in the horizontal leg press and seated chest press machines.

  12. Load-velocity profiles

    Time frame: Change from baseline to week 8

    In the eight-week study, the load-velocity profiles will be analyzed using the velocity values (recorded with a linear velocity transducer) associated with the absolute loads used during the progressive loading tests in the horizontal leg press and seated chest press machines.

  13. Ten-meters walking

    Time frame: Change from baseline to week 8

    In the eight-week study, the 10-meter walking time will be measured through a chronometer.

  14. 1-kg Medicine Ball Throw (MBT)

    Time frame: Change from baseline to week 8

    In the eight-week study, the MBT distance will be recorded with a tape measure.

  15. Handgrip strength (HGS)

    Time frame: Change from baseline to week 8

    In the eight-week study, the HGS will be assessed through an analogic dynamometer.

  16. 6-Minute Walk Test (6MWT)

    Time frame: Change from baseline to week 8

    In the eight-week study, the 6MWT distance will be assessed by multiplying the number of total laps by the lap distance (e.g., 10 laps x 10 meters).

Study contacts

Contact information is provided by the study sponsor or research team.

Nuno Fonseca, Master's

CONTACT

[email protected]

918241354 ext. +351

Sponsors and collaborators

Lead sponsor

University of Beira Interior

Other

Collaborators

  • Research Center in Sports Sciences, Health Sciences and Human Development

Registry information

Official study 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

Acronym: TRAIN4BRAIN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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