Resistance Training to Individuals for Cognitive Impairment With Dementia (TRAIN4BRAIN)

August 1, 2024 updated by: Nuno Miguel Pintassilgo da Silva Fonseca, University of Beira Interior

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
      • Covilhã, Portugal
        • Recruiting
        • University of Beira Interior
        • Contact:
          • Nuno Fonseca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One Resistance Training Set (Single Session)
The participants will perform one resistance training session with one set.
Other: One Resistance Training Set (Single Session)
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.
Experimental: Three Resistance Training Sets (Single Session)
The participants will perform one resistance training session with three sets.
Other: Three Resistance Training Sets (Single Session)
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.
Experimental: One Resistance Training Set (8 Weeks)
The participants will perform eight weeks of resistance training (two sessions per week, separated by 72 hours of rest) with one set.
Other: One Resistance Training Set (8 Weeks)
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.
Experimental: Three Resistance Training Sets (8 Weeks)
The participants will perform eight weeks of resistance training (two sessions per week, separated by 72 hours of rest) with three sets.
Other: Three Resistance Training Sets (8 Weeks)
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.
Experimental: Control (8 Weeks)
The participants will not perform any form of physical exercise during the intervention period of eight weeks.
Other: Control (8 Weeks)
The participants in the control group will maintain their regular daily activities without performing any form of physical exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 0 minutes and 72 hours after the sessions
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.
Change from baseline to 0 minutes and 72 hours after the sessions
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.
Change from baseline to week 8
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.
Change from baseline to week 8
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.
Change from baseline until week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 0 minutes and 72 hours after the sessions
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.
Change from baseline to 0 minutes and 72 hours after the sessions
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.
Change from baseline to 0 minutes and 72 hours after the sessions
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.
Change from baseline to 0 minutes and 72 hours after the sessions
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.
Change from baseline to 0 minutes and 72 hours after the sessions
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.
Change from baseline to week 8
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.
Change from baseline to week 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.
Change from baseline to week 8
HbA1c
Time Frame: Change from baseline to week 8
In the eight-week study, the HbA1c will be analyzed through specific blood testing kits.
Change from baseline to week 8
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.
Change from baseline to week 8
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.
Change from baseline to week 8
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.
Change from baseline to week 8
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.
Change from baseline to week 8
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.
Change from baseline to week 8
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.
Change from baseline to week 8
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).
Change from baseline to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Beira Interior

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mário C Marques, PhD, University of Beira Interior
  • Principal Investigator: Dulce Esteves, PhD, University of Beira Interior
  • Principal Investigator: Mikel Izquierdo, PhD, Universidad Pública de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • University of Beira Interior

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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