Cognitive DeclineEXECONCT04504643
Comparison of Three Motor-cognitive Training Programs
A study testing Technology-assisted circuit training, Conventional circuit training and Nordic walking in people with Cognitive Decline, run by Aix Marseille Université at 1 site in France.
Trial summary
Understanding how to delay age-related physical and mental declines is an issue for aging research. It has been shown that isolated aerobic, coordination and cognitive training improve brain functions and cognitive performances. Moreover, the combination of them leads to greater effects. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Technology-assisted circuit training, Conventional circuit training and Nordic walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 30 Apr 2023
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Considered apt for moderate physical activity practice (validated by a maximal VO2 cycle-ergometer test by a cardiologist)
- Sedentary or moderately active (objectified by the categories obtained at the IPAQ)
- Cognitively healthy (objectified by a score at the MMSE of 26 and above)
Who cannot join
- Colorblindness
- Uncorrected earing and/or visual impairment
- Presence of a known psychiatric or neurologic condition
- Under psychotropic treatment or beta-blockers
Trial locations and contacts
1 site in 1 country.
France1 site
Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)
Marseille
About this study
Official title: Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols
Understanding how to delay age-related physical and mental declines is an issue for aging research. It has been shown that isolated aerobic, coordination and cognitive training improve brain functions and cognitive performances. Moreover, the combination of them leads to greater effects. Different combination modalities are possible: training programs demanding cognitive resources within the activity performed in a natural environment like Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training where training components are systematically combined and their intensity controlled. The aim of this study is to compare three training programs: a Nordic walking one (NW), and two conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT) exercises, while CT-fit characterized by cognitive charge embodied in the movements through the use of technology. An improvement in physical, motor, and cognitive functions is expected by all three groups. However, our primary hypothesis is that the CT-fit will impact executive functions more.
45 healthy independent living community dwellers participants aged 65 to 80 will be recruited. Participants will be included after a general medical examination (geriatric screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of cognitive impairment, (MMSE <26/30), and physical impairments. Participants will be randomly divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour 3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task, Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance test, walking speed and size of the base of support, Timed Up \& Go, Chair sit and reach test and Four square stepping test) and physical assessment (10 m incremental shuttle walking test, maximal handgrip force, 30s chair rise stand).
Improving cognitive functions by adding new technology embodied in a systematically combined training (exergame), would result to be the best solution to optimize training for aging people.
- Conditions
- Cognitive Decline
- Being tested
- Technology-assisted circuit training, Conventional circuit training, Nordic walking
- Keywords
- aging, cognition, cognitive-motor training, Nordic walking
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted circuit trainingOther
Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks
Conventional circuit trainingOther
Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks
Nordic walkingOther
Classic nordic walking 3 times a week for one hour during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Technology-assisted circuit training | Experimental | Multicomponent circuit training using FItLight Trainer™ as an embodied tool to perform motor task. The circuit training is composed by aerobic, muscular, coordination and balance exercises. Receives: Other: Technology-assisted circuit training |
| Conventional circuit training | Experimental | Multicomponent circuit training composed by aerobic, muscular, balance and coordination exercises. Coordination exercises wll be charged of simple dual task cognitive exercises (counting backwards, or making some easy math calculations, repeating words backward, finding words of the same family). Receives: Other: Conventional circuit training |
| Nordic Walking | Experimental | The training sessions are performed in a natural parc, which offers pathways of different lengths and levels of difficulty that will increase over the weeks. Receives: Other: Nordic walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in working memory function through HappyNeuron Software
Assessment for changing in working memory function tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in inhibition processes through Stroop task test
Assessment for changing of inhibition processes tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)
Assessment for changing of switching capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in visuospatial capacities through Rey complex Figure copy task
Assessment for changing of visuospatial capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)
Assessment for chainging for dual task capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in global cognition capacity through the Moca test
Assessment for changing for general cognition tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Secondary outcomes (7)
Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests
Assessment for balance using a force platform for the bipedal upright standing (AMTI, Advanced Mechanical Technology, Inc., MA, USA). Both assessments tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in Gait pattern assessment
Assessment to test gait pattern using a Gait rite (walking at usual speed on a gait rite - GAITRite system, CIR Systems, Havertown, PA, United States) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in functional mobility through the Timed Up & Go test
Assessment for functional mobility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes for flexibility through the Chair-sit and reach test
Assessment for functional flexibility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in motor coordination through the Four- Square Stepping test
Assessment for functional motor coordination tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in muscular strength through Maximal handgrip force test
Assessment for muscular strength (using JAMAR® hand dynamometer) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Changes in cardiovascular capacities through Shuttle walk test
Assessment for cardiovascular capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Oct 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aix Marseille Université
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Jacques TEMPRADO, Aix Marseille Université
- Investigators
- Jean-Jacques Temprado, Ph.D., Principal investigator, Aix Marseille Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504643
- Sponsor's protocol ID
- 2019-A03263-54
- Acronym
- EXECO
- Status last verified
- Feb 2024
- First submitted
- 2 Aug 2020
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols
- ClinicalTrials.gov ID
- NCT04504643
- Acronym / sponsor ID
- EXECO / 2019-A03263-54
- Conditions
- Cognitive Decline
- Keywords
- aging, cognition, cognitive-motor training, Nordic walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aix Marseille UniversitéUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 7 Aug 2020 (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.
Understanding how to delay age-related physical and mental declines is an issue for aging research. It has been shown that isolated aerobic, coordination and cognitive training improve brain functions and cognitive performances. Moreover, the combination of them leads to greater effects. Different combination modalities are possible: training programs demanding cognitive resources within the activity performed in a natural environment like Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training where training components are systematically combined and their intensity controlled. The aim of this study is to compare three training programs: a Nordic walking one (NW), and two conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT) exercises, while CT-fit characterized by cognitive charge embodied in the movements through the use of technology. An improvement in physical, motor, and cognitive functions is expected by all three groups. However, our primary hypothesis is that the CT-fit will impact executive functions more.
45 healthy independent living community dwellers participants aged 65 to 80 will be recruited. Participants will be included after a general medical examination (geriatric screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of cognitive impairment, (MMSE <26/30), and physical impairments. Participants will be randomly divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour 3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task, Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance test, walking speed and size of the base of support, Timed Up \& Go, Chair sit and reach test and Four square stepping test) and physical assessment (10 m incremental shuttle walking test, maximal handgrip force, 30s chair rise stand).
Improving cognitive functions by adding new technology embodied in a systematically combined training (exergame), would result to be the best solution to optimize training for aging people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Technology-assisted circuit training | Experimental | Other: Technology-assisted circuit trainingMulticomponent circuit training using FItLight Trainer™ as an embodied tool to perform motor task. The circuit training is composed by aerobic, muscular, coordination and balance exercises. |
| Conventional circuit training | Experimental | Other: Conventional circuit trainingMulticomponent circuit training composed by aerobic, muscular, balance and coordination exercises. Coordination exercises wll be charged of simple dual task cognitive exercises (counting backwards, or making some easy math calculations, repeating words backward, finding words of the same family). |
| Nordic Walking | Experimental | Other: Nordic walkingThe training sessions are performed in a natural parc, which offers pathways of different lengths and levels of difficulty that will increase over the weeks. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Considered apt for moderate physical activity practice (validated by a maximal VO2 cycle-ergometer test by a cardiologist)
- Sedentary or moderately active (objectified by the categories obtained at the IPAQ)
- Cognitively healthy (objectified by a score at the MMSE of 26 and above)
Key exclusion criteria (4 listed)
- Colorblindness
- Uncorrected earing and/or visual impairment
- Presence of a known psychiatric or neurologic condition
- Under psychotropic treatment or beta-blockers
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 |
|---|---|---|
| Technology-assisted circuit trainingCircuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks | Other | Technology-assisted circuit training |
| Conventional circuit trainingConventional circuit training including single and dual task 3 times a week for one hour during 8 weeks | Other | Conventional circuit training |
| Nordic walkingClassic nordic walking 3 times a week for one hour during 8 weeks | Other | Nordic Walking |
Primary outcome
Changes in working memory function through HappyNeuron Software
Time frame: Through study completion, an average of 9 months
Assessment for changing in working memory function tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Changes in inhibition processes through Stroop task test
Time frame: Through study completion, an average of 9 months
Assessment for changing of inhibition processes tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)
Time frame: Through study completion, an average of 9 months
Assessment for changing of switching capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Changes in visuospatial capacities through Rey complex Figure copy task
Time frame: Through study completion, an average of 9 months
Assessment for changing of visuospatial capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)
Time frame: Through study completion, an average of 9 months
Assessment for chainging for dual task capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
Changes in global cognition capacity through the Moca test
Time frame: Through study completion, an average of 9 months
Assessment for changing for general cognition tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
7 secondary outcomes
Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests
Time frame: Through study completion, an average of 9 months
Changes in Gait pattern assessment
Time frame: Through study completion, an average of 9 months
Changes in functional mobility through the Timed Up & Go test
Time frame: Through study completion, an average of 9 months
Changes for flexibility through the Chair-sit and reach test
Time frame: Through study completion, an average of 9 months
Changes in motor coordination through the Four- Square Stepping test
Time frame: Through study completion, an average of 9 months
Changes in muscular strength through Maximal handgrip force test
Time frame: Through study completion, an average of 9 months
Changes in cardiovascular capacities through Shuttle walk test
Time frame: Through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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.
Jean-Jacques Temprado, Ph.D. principal investigator
Aix Marseille Université
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-assisted circuit training, Conventional circuit training and Nordic walking in people with Cognitive Decline, run by Aix Marseille Université at 1 site in France.
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 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in working memory function through HappyNeuron Software (time frame: Through study completion, an average of 9 months). The study lists 6 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 16 Feb 2024.