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Mild Cognitive ImpairmentTRAIN4BRAINNCT06185010

Resistance Training to Individuals for Cognitive Impairment With Dementia

A study testing One Resistance Training Set (Single Session), Three Resistance Training Sets (Single Session) and One Resistance Training Set (8 Weeks) in people with Mild Cognitive Impairment and Mild Dementia, run by University of Beira Interior at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment, Mild Dementia
What is being tested?
One Resistance Training Set (Single Session), Three Resistance Training Sets (Single Session) and One Resistance Training Set (8 Weeks)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePortugal
Study dates
1 Dec 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Nuno Fonseca, Master's contact

918241354 ext. +351

nuno1977fonseca@gmail.com

Portugal1 site, 1 recruiting
  • University of Beira Interior

    Covilha

    Nuno Fonseca

    Recruiting

Other trials in Portugal

About this study

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

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.

Read the 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.

Being tested
One Resistance Training Set (Single Session), Three Resistance Training Sets (Single Session), One Resistance Training Set (8 Weeks), Three Resistance Training Sets (8 Weeks), Control (8 Weeks)
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06185010
Study groupRoleWhat they receive
One Resistance Training Set (Single Session)ExperimentalThe participants will perform one resistance training session with one set.
Receives: Other: One Resistance Training Set (Single Session)
Three Resistance Training Sets (Single Session)ExperimentalThe participants will perform one resistance training session with three sets.
Receives: Other: Three Resistance Training Sets (Single Session)
One Resistance Training Set (8 Weeks)ExperimentalThe participants will perform eight weeks of resistance training (two sessions per week, separated by 72 hours of rest) with one set.
Receives: Other: One Resistance Training Set (8 Weeks)
Three Resistance Training Sets (8 Weeks)ExperimentalThe participants will perform eight weeks of resistance training (two sessions per week, separated by 72 hours of rest) with three sets.
Receives: Other: Three Resistance Training Sets (8 Weeks)
Control (8 Weeks)ExperimentalThe participants will not perform any form of physical exercise during the intervention period of eight weeks.
Receives: Other: Control (8 Weeks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic blood pressure (SBP)

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

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

  2. Handgrip strength (HGS)

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

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

  3. Dementia Rating Scale-2 (DRS-2)

    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.

    Measured: Change from baseline to week 8

  4. Brain-Derived Neurotrophic Factor (BDNF)

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

    Measured: Change from baseline to week 8

  5. Short Physical Performance Battery (SPPB)

    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.

    Measured: Change from baseline until week 8

Secondary outcomes (16)
  1. Diastolic blood pressure (DBP)

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

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

  2. Heart rate (HR)

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

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

  3. Tympanic temperature (TT)

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

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

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

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

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

  5. 1-kg Medicine Ball Throw (MBT)

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

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

  6. Inflammatory markers

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

    Measured: Change from baseline to week 8

  7. Oxidative stress

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

    Measured: Change from baseline to week 8

  8. Lipid Profile

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

    Measured: Change from baseline to week 8

  9. HbA1c

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

    Measured: Change from baseline to week 8

  10. Muscle Damage

    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.

    Measured: Change from baseline to week 8

  11. One-repetition maximum (1RM)

    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.

    Measured: Change from baseline to week 8

  12. Load-velocity profiles

    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.

    Measured: Change from baseline to week 8

  13. Ten-meters walking

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

    Measured: Change from baseline to week 8

  14. 1-kg Medicine Ball Throw (MBT)

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

    Measured: Change from baseline to week 8

  15. Handgrip strength (HGS)

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

    Measured: Change from baseline to week 8

  16. 6-Minute Walk Test (6MWT)

    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).

    Measured: Change from baseline to week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2023
  2. Study start1 Dec 2023
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06185010
Sponsor's protocol ID
University of Beira Interior
Acronym
TRAIN4BRAIN
Status last verified
Aug 2024
First submitted
14 Dec 2023
Last updated
6 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fonseca NM, Esteves D, Marques DL, Fonseca CP, Costa J, Sousa T, Sousa AC, Neiva HP, Izquierdo M, Marques MC. Effects of Resistance Training Sets on Cognition and Brain-Derived Neurotrophic Factor in Cognitively Impaired Individuals: A Quasi-Experimental Study. J Gerontol A Biol Sci Med Sci. 2026 Sep 1:glag216. doi: 10.1093/gerona/glag216. Online ahead of print.

    PubMed 42678372
  • Fonseca N, Esteves D, Marques DL, Fail LB, Sousa T, Pinto MP, Neiva HP, Izquierdo M, Marques MC. Acute and time-course changes in hemodynamic and physical performance parameters following single and multiple resistance training sets in cognitively impaired individuals: A randomized crossover study. Exp Gerontol. 2025 Mar;201:112688. doi: 10.1016/j.exger.2025.112688. Epub 2025 Jan 23.

    PubMed 39854950

Questions about this trial

What is this clinical trial studying?

A study testing One Resistance Training Set (Single Session), Three Resistance Training Sets (Single Session) and One Resistance Training Set (8 Weeks) in people with Mild Cognitive Impairment and Mild Dementia, run by University of Beira Interior at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nuno Fonseca, Master's (918241354 ext. +351, nuno1977fonseca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic blood pressure (SBP) (time frame: Change from baseline to 0 minutes and 72 hours after the sessions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06185010, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.

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