Cognitive ImpairmentTRAIN4BRAINNCT06528951
Impact of Resistance Training Volume on Cognitive Function and Physical Performance in Cognitively Impaired Individuals
A study testing 15% increase in resistance training volume (10 Weeks), 30% increase in resistance training volume (10 Weeks) and One group that performed 15% more volume and increased to 30% (10 Weeks) in people with Cognitive Impairment, run by University of Beira Interior at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- 15% increase in resistance training volume (10 Weeks), 30% increase in resistance training volume (10 Weeks) and One group that performed 15% more volume and increased to 30% (10 Weeks)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 sitePortugal
- Study dates
- 28 Oct 2023to 29 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Severe comorbidity that negatively influences participation in the training program.
- Surgeries or fractures in the last 6 months.
- Bedridden or hospitalized individuals.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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).
- Conditions
- Cognitive Impairment
- Being tested
- Control Phase ( 6Weeks), 15% increase in resistance training volume (10 Weeks), 30% increase in resistance training volume (10 Weeks), One group that performed 15% more volume and increased to 30% (10 Weeks), One group that performed 30% more volume and increased to 45% (10 Weeks).
- Keywords
- Dementia, Physical exercise, Volume, Functional performance, Healthy aging
- Medical subject headings
- Cognitive Dysfunction, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Phase (6 Weeks) | Experimental | All recruited participants will perform 6 weeks of resistance training with the same volume. 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. Receives: Other: Control Phase ( 6Weeks) |
| 15% increase in resistance training volume (10 Weeks) | Experimental | The participants will perform 10 weeks of resistance training, increasing their initial volume by 15%. Receives: Other: 15% increase in resistance training volume (10 Weeks) |
| 30% increase in resistance training volume (10 Weeks) | Experimental | The participants will perform 10 weeks of resistance training, increasing their initial volume by 30%. Receives: Other: 30% increase in resistance training volume (10 Weeks) |
| 15% + 15% increase in resistance training volume (10 Weeks) | Experimental | The participants will perform 10 weeks of resistance training. The group that performed the 15% volume will increase to 30%. Receives: Other: One group that performed 15% more volume and increased to 30% (10 Weeks) |
| 30% + 15% increase in resistance training volume (10 Weeks) | Experimental | The participants will perform 10 weeks of resistance training. The group that performed the 30% volume will increase to 15%. Receives: Other: One group that performed 30% more volume and increased to 45% (10 Weeks). |
| Control group ( 29 Weeks) | Experimental | The participants will not perform any form of physical exercise during the intervention period of twenty-nine weeks. Receives: Other: Control group ( 29 Weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
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 29
Dementia Rating Scale-2 (DRS-2)
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 until week 29
Brain-Derived Neurotrophic Factor (BDNF)
The BDNF protein levels will be analyzed through specific blood testing kits.
Measured: Change from baseline until week 29
Secondary outcomes (14)
1-kg Medicine Ball Throw (MBT)
The MBT distance will be recorded with a tape measure.
Measured: Change from baseline until week 29
Handgrip strength (HGS)
The HGS will be assessed through an analogic dynamometer.
Measured: Change from baseline until week 29
Ten-meters walking
The 10-meter walking time will be measured with a stopwatch.
Measured: Change from baseline until week 29
1RM leg press and chest press
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.
Measured: Change from baseline until week 29
Six-minute walking test
Walking one distance over 6 minutes will be measured with a stopwatch as the outcome by which to compare changes in performance capacity.
Measured: Change from baseline until week 29
Load-velocity profiles in the leg press and chest press
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 until week 29
Systolic blood pressure (SBP)
In this study the SBP will be assessed through a blood pressure device.
Measured: Change from baseline until week 29
Diastolic blood pressure (DBP)
In this study the DBP will be assessed through a blood pressure device.
Measured: Change from baseline until week 29
Heart Rate (HR)
In this study the HR will be assessed through a digital equipment blood pressure device.
Measured: Change from baseline until week 29
Oxidative stress
Oxidative stress markers (carbonylated proteins) will be analyzed through specific blood testing kits.
Measured: Change from baseline until week 29
Inflammatory markers
Inflammatory markers (IL-6, TNF-α, and IL-10) will be analyzed through specific blood testing kits.
Measured: Change from baseline until week 29
Lipid profile
The lipid profile (LDL, HDL, total cholesterol, triglycerides) will be analyzed through specific blood testing kits.
Measured: Change from baseline until week 29
Glycemic status
The HbA1c will be analyzed through specific blood testing kits.
Measured: Change from baseline until week 29
Muscle damage
The muscle damage (creatine kinase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase) will be analyzed through specific blood testing kits.
Measured: Change from baseline until week 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start28 Oct 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion29 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development
- Responsible party
- Principal investigator, Nuno Miguel Pintassilgo da Silva Fonseca, University of Beira Interior
- Investigators
- Mário M; Marques, PhD, Principal investigator, University of Beira InteriorDulce Esteves, PhD, Principal investigator, University of Beira InteriorMikel Izquierdo, PhD, Principal investigator, Universidad Pública de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528951
- Sponsor's protocol ID
- Universidade da Beira Interior
- Acronym
- TRAIN4BRAIN
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06528951
- Acronym / sponsor ID
- TRAIN4BRAIN / Universidade da Beira Interior
- Conditions
- Cognitive Impairment
- Keywords
- Dementia, Physical exercise, Volume, Functional performance, Healthy aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 29 Sep 2024 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control Phase (6 Weeks) | Experimental | Other: Control Phase ( 6Weeks)All recruited participants will perform 6 weeks of resistance training with the same volume. 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. |
| 15% increase in resistance training volume (10 Weeks) | Experimental | Other: 15% increase in resistance training volume (10 Weeks)The participants will perform 10 weeks of resistance training, increasing their initial volume by 15%. |
| 30% increase in resistance training volume (10 Weeks) | Experimental | Other: 30% increase in resistance training volume (10 Weeks)The participants will perform 10 weeks of resistance training, increasing their initial volume by 30%. |
| 15% + 15% increase in resistance training volume (10 Weeks) | Experimental | Other: One group that performed 15% more volume and increased to 30% (10 Weeks)The participants will perform 10 weeks of resistance training. The group that performed the 15% volume will increase to 30%. |
| 30% + 15% increase in resistance training volume (10 Weeks) | Experimental | Other: One group that performed 30% more volume and increased to 45% (10 Weeks).The participants will perform 10 weeks of resistance training. The group that performed the 30% volume will increase to 15%. |
| Control group ( 29 Weeks) | Experimental | Other: Control group ( 29 Weeks)The participants will not perform any form of physical exercise during the intervention period of twenty-nine weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Severe comorbidity that negatively influences participation in the training program.
- Surgeries or fractures in the last 6 months.
- Bedridden or hospitalized individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Phase ( 6Weeks)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. | Other | Control Phase (6 Weeks) |
| 15% increase in resistance training volume (10 Weeks)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. | Other | 15% increase in resistance training volume (10 Weeks) |
| 30% increase in resistance training volume (10 Weeks)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. | Other | 30% increase in resistance training volume (10 Weeks) |
| One group that performed 15% more volume and increased to 30% (10 Weeks)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. | Other | 15% + 15% increase in resistance training volume (10 Weeks) |
| One group that performed 30% more volume and increased to 45% (10 Weeks).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. | Other | 30% + 15% increase in resistance training volume (10 Weeks) |
| Control group ( 29 Weeks)The participants in the control group will maintain their regular daily activities without performing any form of physical exercise. | Other | Control group ( 29 Weeks) |
Primary outcome
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.
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.
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.
14 secondary outcomes
1-kg Medicine Ball Throw (MBT)
Time frame: Change from baseline until week 29
Handgrip strength (HGS)
Time frame: Change from baseline until week 29
Ten-meters walking
Time frame: Change from baseline until week 29
1RM leg press and chest press
Time frame: Change from baseline until week 29
Six-minute walking test
Time frame: Change from baseline until week 29
Load-velocity profiles in the leg press and chest press
Time frame: Change from baseline until week 29
Systolic blood pressure (SBP)
Time frame: Change from baseline until week 29
Diastolic blood pressure (DBP)
Time frame: Change from baseline until week 29
Heart Rate (HR)
Time frame: Change from baseline until week 29
Oxidative stress
Time frame: Change from baseline until week 29
Inflammatory markers
Time frame: Change from baseline until week 29
Lipid profile
Time frame: Change from baseline until week 29
Glycemic status
Time frame: Change from baseline until week 29
Muscle damage
Time frame: Change from baseline until week 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mário M; Marques, PhD principal investigator
University of Beira Interior
Dulce Esteves, PhD principal investigator
University of Beira Interior
Mikel Izquierdo, PhD principal investigator
Universidad Pública de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15% increase in resistance training volume (10 Weeks), 30% increase in resistance training volume (10 Weeks) and One group that performed 15% more volume and increased to 30% (10 Weeks) in people with Cognitive Impairment, 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 3 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 30 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: Change from baseline until week 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.