Mild Cognitive Impairment (MCI)NCT06755164
Effects of Combined Aerobic and Cognitive Training in a Simultaneous or Sequential Paradigm on Cognition and Brain Functional Activity in Patients with AMCI
A study testing Simultaneous aerobic and cognitive training (SIM) and Sequential aerobic and cognitive training (SEQ) in people with Mild Cognitive Impairment (MCI) and AMCI - Amnestic Mild Cognitive Impairment, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Mild Cognitive Impairment (MCI) is a condition in which patients show an objective evidence of impairment in one or more cognitive domains but a spared independence in daily functional abilities. The cognitive domain which results to be the most impaired defines the clinical subtype. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), AMCI - Amnestic Mild Cognitive Impairment, Neurodegenerative Dementia
- What is being tested?
- Simultaneous aerobic and cognitive training (SIM) and Sequential aerobic and cognitive training (SEQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 5 Apr 2019to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a diagnosis of amnesic mild cognitive impairment according to the current diagnostic criteria;
- age>60 years;
- stable acetylcholinesterase inhibitors and/or memantine at the time of enrolment for at least one month;
- subscription of the consent for personal data treatment and patients' informed consent for participation in the present study.
Who cannot join
- patients with a history of other systemic, neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at an MRI scan;
- patients with a family history of neurodegenerative disorders;
- patients with a history of alcohol and/or psychotropic drugs abuse;
- patients who are used to do regular physical and/or cognitive activity;
- contraindication to perform MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with magnetic field generated by MRI, claustrophobia, pregnancy, breastfeeding).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Aerobic and Cognitive Training in a Simultaneous or Sequential Paradigm on Cognition and Brain Functional Activity in Patients with Amnesic Mild Cognitive Impairment
Mild Cognitive Impairment (MCI) is a condition in which patients show an objective evidence of impairment in one or more cognitive domains but a spared independence in daily functional abilities. The cognitive domain which results to be the most impaired defines the clinical subtype. Specifically, the amnestic subtype of MCI (aMCI), which is the most frequent, is characterised by deficits in episodic memory and visuospatial abilities. Current literature reports that prompt and focused rehabilitation provided early in the disease course might slow down the development of the neurodegenerative condition. The coupling between cognitive and aerobic trainings is the most incisive non-pharmacological treatment, and its effects have been demonstrated to have an impact on global cognitive functions, quality of life, aerobic capacity, and mood in the elderly with aMCI. However, the best modality for coupling aerobic and cognitive trainings (i.e., whether sequential-SEQ: aerobic training followed by cognitive training; or simultaneous-SIM: cognitive training during aerobic training) is still unknown. The aim of the present study is to determine which modality, among SEQ or SIM, is the most incisive training in patients with aMCI. Using a Randomized Controlled design, the effect of this combined aerobic-cognitive non-pharmachological training in both modalities will be evaluated on cognitive changes assessed with standard and computerized neuropsychological batteries and in functional activity during a task-based functional Magnetic Resonance Imaging (fMRI) scan.
Read the detailed description
This study will be the first one aimed at investigating the effects of a combined aerobic and cognitive training in the two different paradigms (SIM and SEQ) on cognitive functioning and brain functional MRI activity in patients with aMCI. Previous studies on aMCI patients reported that the combination of cognitive and aerobic training is more effective than the single treatments alone on both clinical and MRI outcome measures. Specifically, with the proposed training we expect to obtain ameliorative effects in terms of episodic memory, visuospatial abilities, cerebral activity and aerobic capacities, with a consequent benefit on quality of life and mood in both experimental groups; in addition, we also expect a reduction of IL-6 and TNF-alpha expression levels, and an enhancement of the BDNF.
The combined aerobic-cognitive training (in SIM and SEQ modalities) will have a duration of 3 months, with 24 sessions scheduled twice a week for 70 minutes each.
The first session will last 10 minutes more compared to the others in order to provide participants with all information concerning the cognitive task that they will perform during (in SIM condition) or after the aerobic training (in SEQ condition).
Aerobic and cognitive exercises will be the same for both groups (SIM and SEQ) and will be characterized as follows:
- Aerobic training: 30 minutes of cyclette at 40-59% heart rate reserve (HRR) or 64-76% maximum heart rate (corresponding at Rating of Perceived Exertion by Borg -BORG RPE= 12-13 -moderate intensity-).16 The cardiac frequency will be monitored by pulse oxymeter.
- Cognitive training: the entire training will last for 30 minutes and will consist of two cycles of a memory task (lasting 10 minutes) and a visuospatial task (5 minutes).
For the SIM condition, patient will perform the cognitive training sited on the cyclette using an adapted computer screen and a joystick.
For the SEQ condition, patient will perform the cognitive training sited on a desk using a computer and a joystick.
The aerobic training will be performed on a cyclette. For the cognitive training, the cognitive exercises will train two cognitive domain 1) memory and 2) visuospatial function. 1) During the mnemonic exercises, the patients will be asked to observe a screen on which different stimuli (objects) will be presented and to remember all of them. Then the subjects will be asked to recall the most of the observed objects. The number of stimuli (objects) will progressively increase in order to progressively improving the difficulty of the mnemonic training. 2) The visuospatial task will consist on the navigation in a labyrinth projected onto a screen. The subjects will have a mouse/joystick with which they will move through the labyrinth in order to find the shortest way to exit.
- Conditions
- Mild Cognitive Impairment (MCI), AMCI - Amnestic Mild Cognitive Impairment, Neurodegenerative Dementia, Neurodegenerative Disease
- Being tested
- Simultaneous aerobic and cognitive training (SIM), Sequential aerobic and cognitive training (SEQ)
- Keywords
- Neurorehabilitation, cognitive training, aerobic training, combined training, cognitive rehabilitation, episodic memory, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous aerobic and cognitive training (SIM)Other
The SIMULTANEOUS Group (SIM) will undergo15 minutes of stretching and preparatory mobilization + 40 minutes of cyclette (5 minutes warm-up, 30 minutes aerobic and cognitive training, 5 minutes cool-down) + 15 minutes of mobilization and deep breathing (total: 70 minutes). Patients will perform the cognitive training sited on the cyclette using an adapted computer screen and a joystick.
Sequential aerobic and cognitive training (SEQ)Other
The SEQUENTIAL Group (SEQ) will undergo 40 minutes of cyclette (5 minutes warm-up, 30 minutes aerobic training, 5 minutes cool-down), + 30 minutes of cognitive training (total: 70 minutes). Patients will perform the cognitive training after the aerobic training, sited on a desk using a computer and a joystick.
| Study group | Role | What they receive |
|---|---|---|
| SIM (simultaneous aerobic and cognitive training) | Experimental | In the SIMULTANEOUS Group (SIM), the aerobic and cognitive training will be performed simultaneously (i.e. the cognitive training will be performed during the aerobic training). Receives: Other: Simultaneous aerobic and cognitive training (SIM) |
| SEQ (sequential aerobic and cognitive training) | Experimental | In the SEQUENTIAL Group (SEQ), the aerobic and cognitive training will be performed sequentially (i.e. the cognitive training will follow the aerobic training). Receives: Other: Sequential aerobic and cognitive training (SEQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory improvement
The primary aim of the study is to investigate episodic memory improvement (investigated with changes in the Alzheimer's Disease Assessment Scale (ADAS-cog scale), both in short- (sooner after training) and in long-term (6 months after training). ADAS-Cog scale is a useful tool which is widely employed to assess global cognitive functioning in patients with several neurodegenerative conditions including MCI. Range score is from 0 to 70. Lower scores indicate better performance.
Measured: Baseline, month 3, month 9
Secondary outcomes (11)
Functional MRI changes
Modifications in cerebral functional activity, measured through BOLD signal, soon after training using a task-based fMRI approach.
Measured: Baseline, month 3
Changes in submaximal aerobic/functional walking capacity
The 6-minute walking test (6MWT) measures the distance a subject walks in 6 minutes and is used to assess changes in performance capacity
Measured: Baseline, month 3, month 9
Mood changes
Changes in mood, as measured by the Beck Depression Inventory (BDI), following treatment at both short- and long-term follow-up. BDI is a 21-item, self-administered questionnaire designed to assess the severity of respondents' depression during the weeks prior to completing the questionnaire.
Measured: Baseline, month 3, month 9
Quality of life changes
Modifications in quality of life as measured by the 12-item Short Form Survey (SF-12) after treatment at the short- and long-term follow up. The SF-12 is a 12-questions instrument for assessing self-reported health-related quality of life.
Measured: Baseline, month 3, month 9
Inflammatory cytokines changes
To observe a reduction in inflammatory cytokines expression levels, specifically in interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-alpha) levels, measured at the short- and long-term follow up. This biochemical effects will have a positive effect on brain-derived neurotrophic factor (BDNF).
Measured: Baseline, month 3, month 9
Correlation between BOLD activity during task-based fMRI and after-treatment changes in cognition
Correlation between fMRI BOLD activity and changes in cognitive function in both conditions (SIM and SEQ) after treatment at short and at long-term follow up.
Measured: month 3, month 9
Correlation between after-treatment changes in BOLD fMRI activity and cognition
Correlation between changes in BOLD activity and cognitive functioning in both conditions (SIM and SEQ) after treatment at short and at long-term follow up.
Measured: Month 3
Correlation between biological factors and after-treatment changes in cognition
Correlation between changes in cognitive functioning and biological factors in both conditions (SIM and SEQ) after treatment at short and at long-term follow up.
Measured: Baseline, month 3, month 9
Differences in patterns of brain activation between HC and patients
To study brain activation differences between patients and healthy subjects by comparing fMRI BOLD activity.
Measured: Baseline
Cognitive differences between HC and patients
Baseline cognitive differences between patients and healthy subjects using the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog scale).
Measured: Baseline
Biological differences between HC and patients
Biological differences in BDNF, IL-6, and TNF-alpha levels between patients and healthy controls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start5 Apr 2019
- Primary completion16 Jan 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Model description
- This study is a national, monocentric, double-blind, randomized, controlled, comparative, multi-parametric and parallel-group trial. Patients with a diagnosis of aMCI will be screened to establish eligibility for participation. Once enrolled, participants will be randomized through random.org software in the two experimental groups: 1) SIM (simultaneous) and 2) SEQ (sequential) aerobic-cognitive training. Allocation concealment will be carried out through closed and opaque mails by a blind operator. All patients will undergo the combined training for 3 months, with sessions scheduled twice a week, lasting 70 minutes each.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755164
- Sponsor's protocol ID
- aMCI SIM-SEQ
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Lam LC, Chan WC, Leung T, Fung AW, Leung EM. Would older adults with mild cognitive impairment adhere to and benefit from a structured lifestyle activity intervention to enhance cognition?: a cluster randomized controlled trial. PLoS One. 2015 Mar 31;10(3):e0118173. doi: 10.1371/journal.pone.0118173. eCollection 2015.
PubMed 25826620Perneczky R, Pohl C, Sorg C, Hartmann J, Tosic N, Grimmer T, Heitele S, Kurz A. Impairment of activities of daily living requiring memory or complex reasoning as part of the MCI syndrome. Int J Geriatr Psychiatry. 2006 Feb;21(2):158-62. doi: 10.1002/gps.1444.
PubMed 16416470Train the Brain Consortium. Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. Sci Rep. 2017 Jan 3;7:39471. doi: 10.1038/srep39471.
PubMed 28045051Suo C, Singh MF, Gates N, Wen W, Sachdev P, Brodaty H, Saigal N, Wilson GC, Meiklejohn J, Singh N, Baune BT, Baker M, Foroughi N, Wang Y, Mavros Y, Lampit A, Leung I, Valenzuela MJ. Therapeutically relevant structural and functional mechanisms triggered by physical and cognitive exercise. Mol Psychiatry. 2016 Nov;21(11):1633-1642. doi: 10.1038/mp.2016.19. Epub 2016 Mar 22.
PubMed 27001615Baglio F, Griffanti L, Saibene FL, Ricci C, Alberoni M, Critelli R, Villanelli F, Fioravanti R, Mantovani F, D'amico A, Cabinio M, Preti MG, Nemni R, Farina E. Multistimulation group therapy in Alzheimer's disease promotes changes in brain functioning. Neurorehabil Neural Repair. 2015 Jan;29(1):13-24. doi: 10.1177/1545968314532833. Epub 2014 Apr 29.
PubMed 24788581Stigger FS, Zago Marcolino MA, Portela KM, Plentz RDM. Effects of Exercise on Inflammatory, Oxidative, and Neurotrophic Biomarkers on Cognitively Impaired Individuals Diagnosed With Dementia or Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. J Gerontol A Biol Sci Med Sci. 2019 Apr 23;74(5):616-624. doi: 10.1093/gerona/gly173.
PubMed 30084942Canu E, Sarasso E, Filippi M, Agosta F. Effects of pharmacological and nonpharmacological treatments on brain functional magnetic resonance imaging in Alzheimer's disease and mild cognitive impairment: a critical review. Alzheimers Res Ther. 2018 Feb 20;10(1):21. doi: 10.1186/s13195-018-0347-1.
PubMed 29458420Anderson-Hanley C, Barcelos NM, Zimmerman EA, Gillen RW, Dunnam M, Cohen BD, Yerokhin V, Miller KE, Hayes DJ, Arciero PJ, Maloney M, Kramer AF. The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. Front Aging Neurosci. 2018 May 4;10:76. doi: 10.3389/fnagi.2018.00076. eCollection 2018.
PubMed 29780318McEwen SC, Siddarth P, Rahi B, Kim Y, Mui W, Wu P, Emerson ND, Lee J, Greenberg S, Shelton T, Kaiser S, Small GW, Merrill DA. Simultaneous Aerobic Exercise and Memory Training Program in Older Adults with Subjective Memory Impairments. J Alzheimers Dis. 2018;62(2):795-806. doi: 10.3233/JAD-170846.
PubMed 29480182Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.
PubMed 28912076Kavirajan H, Schneider LS. Efficacy and adverse effects of cholinesterase inhibitors and memantine in vascular dementia: a meta-analysis of randomised controlled trials. Lancet Neurol. 2007 Sep;6(9):782-92. doi: 10.1016/S1474-4422(07)70195-3.
PubMed 17689146Versijpt J. Effectiveness and cost-effectiveness of the pharmacological treatment of Alzheimer's disease and vascular dementia. J Alzheimers Dis. 2014;42 Suppl 3:S19-25. doi: 10.3233/JAD-132639.
PubMed 25061049Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
PubMed 27583652Gauthier S, Reisberg B, Zaudig M, Petersen RC, Ritchie K, Broich K, Belleville S, Brodaty H, Bennett D, Chertkow H, Cummings JL, de Leon M, Feldman H, Ganguli M, Hampel H, Scheltens P, Tierney MC, Whitehouse P, Winblad B; International Psychogeriatric Association Expert Conference on mild cognitive impairment. Mild cognitive impairment. Lancet. 2006 Apr 15;367(9518):1262-70. doi: 10.1016/S0140-6736(06)68542-5.
PubMed 16631882
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Aerobic and Cognitive Training in a Simultaneous or Sequential Paradigm on Cognition and Brain Functional Activity in Patients with Amnesic Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06755164
- Acronym / sponsor ID
- aMCI SIM-SEQ
- Conditions
- Mild Cognitive Impairment (MCI), AMCI - Amnestic Mild Cognitive Impairment, Neurodegenerative Dementia, Neurodegenerative Disease
- Keywords
- Neurorehabilitation, cognitive training, aerobic training, combined training, cognitive rehabilitation, episodic memory, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 1 Jan 2025 (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.
Mild Cognitive Impairment (MCI) is a condition in which patients show an objective evidence of impairment in one or more cognitive domains but a spared independence in daily functional abilities. The cognitive domain which results to be the most impaired defines the clinical subtype. Specifically, the amnestic subtype of MCI (aMCI), which is the most frequent, is characterised by deficits in episodic memory and visuospatial abilities. Current literature reports that prompt and focused rehabilitation provided early in the disease course might slow down the development of the neurodegenerative condition. The coupling between cognitive and aerobic trainings is the most incisive non-pharmacological treatment, and its effects have been demonstrated to have an impact on global cognitive functions, quality of life, aerobic capacity, and mood in the elderly with aMCI. However, the best modality for coupling aerobic and cognitive trainings (i.e., whether sequential-SEQ: aerobic training followed by cognitive training; or simultaneous-SIM: cognitive training during aerobic training) is still unknown. The aim of the present study is to determine which modality, among SEQ or SIM, is the most incisive training in patients with aMCI. Using a Randomized Controlled design, the effect of this combined aerobic-cognitive non-pharmachological training in both modalities will be evaluated on cognitive changes assessed with standard and computerized neuropsychological batteries and in functional activity during a task-based functional Magnetic Resonance Imaging (fMRI) scan.
Detailed description
This study will be the first one aimed at investigating the effects of a combined aerobic and cognitive training in the two different paradigms (SIM and SEQ) on cognitive functioning and brain functional MRI activity in patients with aMCI. Previous studies on aMCI patients reported that the combination of cognitive and aerobic training is more effective than the single treatments alone on both clinical and MRI outcome measures. Specifically, with the proposed training we expect to obtain ameliorative effects in terms of episodic memory, visuospatial abilities, cerebral activity and aerobic capacities, with a consequent benefit on quality of life and mood in both experimental groups; in addition, we also expect a reduction of IL-6 and TNF-alpha expression levels, and an enhancement of the BDNF.
The combined aerobic-cognitive training (in SIM and SEQ modalities) will have a duration of 3 months, with 24 sessions scheduled twice a week for 70 minutes each.
The first session will last 10 minutes more compared to the others in order to provide participants with all information concerning the cognitive task that they will perform during (in SIM condition) or after the aerobic training (in SEQ condition).
Aerobic and cognitive exercises will be the same for both groups (SIM and SEQ) and will be characterized as follows:
- Aerobic training: 30 minutes of cyclette at 40-59% heart rate reserve (HRR) or 64-76% maximum heart rate (corresponding at Rating of Perceived Exertion by Borg -BORG RPE= 12-13 -moderate intensity-).16 The cardiac frequency will be monitored by pulse oxymeter.
- Cognitive training: the entire training will last for 30 minutes and will consist of two cycles of a memory task (lasting 10 minutes) and a visuospatial task (5 minutes).
For the SIM condition, patient will perform the cognitive training sited on the cyclette using an adapted computer screen and a joystick.
For the SEQ condition, patient will perform the cognitive training sited on a desk using a computer and a joystick.
The aerobic training will be performed on a cyclette. For the cognitive training, the cognitive exercises will train two cognitive domain 1) memory and 2) visuospatial function. 1) During the mnemonic exercises, the patients will be asked to observe a screen on which different stimuli (objects) will be presented and to remember all of them. Then the subjects will be asked to recall the most of the observed objects. The number of stimuli (objects) will progressively increase in order to progressively improving the difficulty of the mnemonic training. 2) The visuospatial task will consist on the navigation in a labyrinth projected onto a screen. The subjects will have a mouse/joystick with which they will move through the labyrinth in order to find the shortest way to exit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a national, monocentric, double-blind, randomized, controlled, comparative, multi-parametric and parallel-group trial. Patients with a diagnosis of aMCI will be screened to establish eligibility for participation. Once enrolled, participants will be randomized through random.org software in the two experimental groups: 1) SIM (simultaneous) and 2) SEQ (sequential) aerobic-cognitive training. Allocation concealment will be carried out through closed and opaque mails by a blind operator. All patients will undergo the combined training for 3 months, with sessions scheduled twice a week, lasting 70 minutes each.
| Arm | Type | Receives |
|---|---|---|
| SIM (simultaneous aerobic and cognitive training) | Experimental | Other: Simultaneous aerobic and cognitive training (SIM)In the SIMULTANEOUS Group (SIM), the aerobic and cognitive training will be performed simultaneously (i.e. the cognitive training will be performed during the aerobic training). |
| SEQ (sequential aerobic and cognitive training) | Experimental | Other: Sequential aerobic and cognitive training (SEQ)In the SEQUENTIAL Group (SEQ), the aerobic and cognitive training will be performed sequentially (i.e. the cognitive training will follow the aerobic training). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of amnesic mild cognitive impairment according to the current diagnostic criteria;
- age>60 years;
- stable acetylcholinesterase inhibitors and/or memantine at the time of enrolment for at least one month;
- subscription of the consent for personal data treatment and patients' informed consent for participation in the present study.
Key exclusion criteria (5 listed)
- patients with a history of other systemic, neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at an MRI scan;
- patients with a family history of neurodegenerative disorders;
- patients with a history of alcohol and/or psychotropic drugs abuse;
- patients who are used to do regular physical and/or cognitive activity;
- contraindication to perform MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with magnetic field generated by MRI, claustrophobia, pregnancy, breastfeeding).
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 |
|---|---|---|
| Simultaneous aerobic and cognitive training (SIM)The SIMULTANEOUS Group (SIM) will undergo15 minutes of stretching and preparatory mobilization + 40 minutes of cyclette (5 minutes warm-up, 30 minutes aerobic and cognitive training, 5 minutes cool-down) + 15 minutes of mobilization and deep breathing (total: 70 minutes). Patients will perform the cognitive training sited on the cyclette using an adapted computer screen and a joystick. | Other | SIM (simultaneous aerobic and cognitive training) |
| Sequential aerobic and cognitive training (SEQ)The SEQUENTIAL Group (SEQ) will undergo 40 minutes of cyclette (5 minutes warm-up, 30 minutes aerobic training, 5 minutes cool-down), + 30 minutes of cognitive training (total: 70 minutes). Patients will perform the cognitive training after the aerobic training, sited on a desk using a computer and a joystick. | Other | SEQ (sequential aerobic and cognitive training) |
Primary outcome
Episodic memory improvement
Time frame: Baseline, month 3, month 9
The primary aim of the study is to investigate episodic memory improvement (investigated with changes in the Alzheimer's Disease Assessment Scale (ADAS-cog scale), both in short- (sooner after training) and in long-term (6 months after training). ADAS-Cog scale is a useful tool which is widely employed to assess global cognitive functioning in patients with several neurodegenerative conditions including MCI. Range score is from 0 to 70. Lower scores indicate better performance.
11 secondary outcomes
Functional MRI changes
Time frame: Baseline, month 3
Changes in submaximal aerobic/functional walking capacity
Time frame: Baseline, month 3, month 9
Mood changes
Time frame: Baseline, month 3, month 9
Quality of life changes
Time frame: Baseline, month 3, month 9
Inflammatory cytokines changes
Time frame: Baseline, month 3, month 9
Correlation between BOLD activity during task-based fMRI and after-treatment changes in cognition
Time frame: month 3, month 9
Correlation between after-treatment changes in BOLD fMRI activity and cognition
Time frame: Month 3
Correlation between biological factors and after-treatment changes in cognition
Time frame: Baseline, month 3, month 9
Differences in patterns of brain activation between HC and patients
Time frame: Baseline
Cognitive differences between HC and patients
Time frame: Baseline
Biological differences between HC and patients
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Background: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Background: PubMed 25826620Lam LC, Chan WC, Leung T, Fung AW, Leung EM. Would older adults with mild cognitive impairment adhere to and benefit from a structured lifestyle activity intervention to enhance cognition?: a cluster randomized controlled trial. PLoS One. 2015 Mar 31;10(3):e0118173. doi: 10.1371/journal.pone.0118173. eCollection 2015.
- Background: PubMed 16416470Perneczky R, Pohl C, Sorg C, Hartmann J, Tosic N, Grimmer T, Heitele S, Kurz A. Impairment of activities of daily living requiring memory or complex reasoning as part of the MCI syndrome. Int J Geriatr Psychiatry. 2006 Feb;21(2):158-62. doi: 10.1002/gps.1444.
- Background: PubMed 28045051Train the Brain Consortium. Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. Sci Rep. 2017 Jan 3;7:39471. doi: 10.1038/srep39471.
- Background: PubMed 27001615Suo C, Singh MF, Gates N, Wen W, Sachdev P, Brodaty H, Saigal N, Wilson GC, Meiklejohn J, Singh N, Baune BT, Baker M, Foroughi N, Wang Y, Mavros Y, Lampit A, Leung I, Valenzuela MJ. Therapeutically relevant structural and functional mechanisms triggered by physical and cognitive exercise. Mol Psychiatry. 2016 Nov;21(11):1633-1642. doi: 10.1038/mp.2016.19. Epub 2016 Mar 22.
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- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous aerobic and cognitive training (SIM) and Sequential aerobic and cognitive training (SEQ) in people with Mild Cognitive Impairment (MCI) and AMCI - Amnestic Mild Cognitive Impairment, run by IRCCS San Raffaele at 1 site in Italy.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Episodic memory improvement (time frame: Baseline, month 3, month 9). 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 NCT06755164, which also lists 16 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 10 Jan 2025.