Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06528951

Impact of Resistance Training Volume on Cognitive Function and Physical Performance in Cognitively Impaired Individuals

This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance in cognitively impaired participants. First, the participants will perform six weeks of resistance training using the same volume for all participants (control phase). The total training volume (sets x repetitions) will be 232 repetitions in the leg press and 160 repetitions in the chest press, with relative intensities ranging from 40% to 70% of 1RM. In week 7, the participants will perform the pre-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance. After the pre-test, the participants will be randomly assigned into two training groups to perform a 10-week intervention. One group will increase the training volume by 15% concerning the training program performed in the control phase, while the other group will increase the volume by 30%. Participants will perform a control test one week after the intervention to assess hemodynamic parameters and physical performance. One week after the control test, the participants will perform another 10-week resistance training program, where the group that performed a volume of 15% will perform 30%, and the group that performed 30% will perform 45%. One week after the intervention, the participants will perform the post-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, hemodynamic response, and physical performance. The investigators hypothesize that both training volumes will induce similar adaptations in cognitive function, oxidative stress, immune response, lipid profile, glycemic status, muscle damage, hemodynamics, and physical performance in cognitively impaired individuals.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cognitive Impairment Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Motor Activity Nervous System Diseases 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

About this study

Following specific inclusion and exclusion criteria (see Eligibility Criteria), participants will be recruited from residential care facilities or day centers. They will perform two different resistance training volumes with two weekly sessions. The intensity of the exercises, the type and order, movement velocity, and rest time between exercises will be the same in both groups. First, a six-week control phase will be carried out, during which all participants will perform the same resistance training volume (control phase). The total training volume (sets x repetitions) will be 232 repetitions in the leg press and 160 repetitions in the chest press, with relative intensities ranging from 40% to 70% of 1RM. After the control phase, a pre-test will be carried out to evaluate cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, blood pressure, heart rate, Short Physical Performance Battery (SPPB: balance, 4-meter walking, and five-repetition sit-to-stand), medicine ball throw (1Kg), handgrip strength, 1RM leg press, and 1RM chest press. After the pre-test, the participants will be randomly assigned into two groups to perform a 10-week resistance training program with different training volumes: one group will increase the training volume by 15% concerning the training program performed in the control phase, while the other group will increase the volume by 30%. After the 10-week intervention, a control test will be performed to evaluate blood pressure, heart rate, SPPB, medicine ball throw (1 kg), handgrip strength, 1RM leg press, and 1RM chest press. After the control test, the participants will perform another 10-week resistance training program where the group that performed the 15% volume will increase to 30% and the 30% volume to 45%. After the second 10-week intervention program, participants will perform the post-test, and the outcome measures will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, blood pressure, heart rate, SPPB, medicine ball throw (1 kg), handgrip strength, 1RM leg press, and 1RM chest press. A control group (without any form of physical exercise), recruited at the beginning of the research project, will also be part of the study. The control group will also undergo a battery of tests before and after the intervention. The outcome measures in the control group will be cognitive function, oxidative stress, inflammatory markers, lipid profile, glycemic status, muscle damage, and SPPB (balance, 4-meter walking, and five-repetition sit-to-stand).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women aged ≥ 50 years old, diagnosed with cognitive impairment (mild, moderate, or severe) through the Dementia Rating Scale-2.
  • SPPB score ≥ 3.
  • Willingness to participate in training programs and collaborate with the research team.
  • Able to provide informed consent (oral or written).

Exclusion criteria

  • Severe comorbidity that negatively influences participation in the training program.
  • Surgeries or fractures in the last 6 months.
  • Bedridden or hospitalized individuals.

Treatment and study plan

Control Phase ( 6Weeks)

Other

The participants will perform a control phase of six weeks of resistance training using the same volume for the upper (160 repetitions) and lower limbs (230 repetitions), with relative intensities ranging from 40% to 70% of 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 5-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 5-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 6-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 5-7 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

15% increase in resistance training volume (10 Weeks)

Other

The participants will perform ten weeks of resistance training, increasing their initial volume by 15% (upper limbs - 184 repetitions; lower limbs - 268 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 3-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 3-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 4-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 3-8 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

30% increase in resistance training volume (10 Weeks)

Other

The participants will perform ten weeks of resistance training, increasing their initial volume by 30% (upper limbs - 208 repetitions; lower limbs - 300 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 4-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 4-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 5-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 4-7 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

One group that performed 15% more volume and increased to 30% (10 Weeks)

Other

The participants will perform 10 weeks of resistance training. The group that performed a 15% volume will now increase more by 15% and perform 30% (upper limbs - 208 repetitions; lower limbs - 300 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 4-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 4-10 repetitions at 40-60% 1RM in the chest press, iv) 1-3 sets of 5-10 repetitions in the sit-to-stand exercise, v) 1-3 sets of 4-7 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

One group that performed 30% more volume and increased to 45% (10 Weeks).

Other

The participants will perform 10 weeks of resistance training. The group that performed a 30% volume will now increase more by 15% and perform 45% (upper limbs - 232 repetitions; lower limbs - 334 repetitions). The number of sets will range from 1 to 3, and the relative intensities from 40% to 70% 1RM. The training sequence will be the following: i) 10 minutes of warmup walking on the treadmill, ii) 1-3 sets of 3-10 repetitions at 50-70% of 1RM in the leg press, iii) 1-3 sets of 3-10 repetitions at 40-60% 1RM in the chest press, iv) 2-3 sets of 8 repetitions in the sit-to-stand exercise, v) 2-3 sets of 8 repetitions in the 1- kg medicine ball throw, and vi) 5 minutes walking on the treadmill.

Control group ( 29 Weeks)

Other

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

Primary outcomes

  1. Short Physical Performance Battery

    Time frame: Change from baseline until week 29

    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.

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

    Time frame: Change from baseline until week 29

    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.

  3. Brain-Derived Neurotrophic Factor (BDNF)

    Time frame: Change from baseline until week 29

    The BDNF protein levels will be analyzed through specific blood testing kits.

Secondary outcomes

  1. 1-kg Medicine Ball Throw (MBT)

    Time frame: Change from baseline until week 29

    The MBT distance will be recorded with a tape measure.

  2. Handgrip strength (HGS)

    Time frame: Change from baseline until week 29

    The HGS will be assessed through an analogic dynamometer.

  3. Ten-meters walking

    Time frame: Change from baseline until week 29

    The 10-meter walking time will be measured with a stopwatch.

  4. 1RM leg press and chest press

    Time frame: Change from baseline until week 29

    A progressive loading test until reaching the load (weight) that can be lifted once (i.e., the one-repetition maximum) will be assessed in the leg and chest press.

  5. Six-minute walking test

    Time frame: Change from baseline until week 29

    Walking one distance over 6 minutes will be measured with a stopwatch as the outcome by which to compare changes in performance capacity.

  6. Load-velocity profiles in the leg press and chest press

    Time frame: Change from baseline until week 29

    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.

  7. Systolic blood pressure (SBP)

    Time frame: Change from baseline until week 29

    In this study the SBP will be assessed through a blood pressure device.

  8. Diastolic blood pressure (DBP)

    Time frame: Change from baseline until week 29

    In this study the DBP will be assessed through a blood pressure device.

  9. Heart Rate (HR)

    Time frame: Change from baseline until week 29

    In this study the HR will be assessed through a digital equipment blood pressure device.

  10. Oxidative stress

    Time frame: Change from baseline until week 29

    Oxidative stress markers (carbonylated proteins) will be analyzed through specific blood testing kits.

  11. Inflammatory markers

    Time frame: Change from baseline until week 29

    Inflammatory markers (IL-6, TNF-α, and IL-10) will be analyzed through specific blood testing kits.

  12. Lipid profile

    Time frame: Change from baseline until week 29

    The lipid profile (LDL, HDL, total cholesterol, triglycerides) will be analyzed through specific blood testing kits.

  13. Glycemic status

    Time frame: Change from baseline until week 29

    The HbA1c will be analyzed through specific blood testing kits.

  14. Muscle damage

    Time frame: Change from baseline until week 29

    The muscle damage (creatine kinase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase) will be analyzed through specific blood testing kits.

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, Inflammatory Markers, Lipid Profile, Glycemic Status, Muscle Damage, Hemodynamic Response, and Physical Performance in Cognitively Impaired Individuals - the TRAIN4BRAIN Study

Acronym: TRAIN4BRAIN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.