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Executive FunctionsVIBALNCT03823183

Multi-domain Versus Uni-Domain Training on Executive Control and Memory Functions of Older Adults

A study testing Cognitive training and Physical training in people with Executive Functions and Memory Functions, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Age-related cognitive decline affects negatively daily living and quality of life of older adults. Previous research has shown a moderate impact of cognitive and physical training on the cognitive functioning of elders. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Executive Functions, Memory Functions
What is being tested?
Cognitive training and Physical training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
1 Oct 2018to 31 Dec 2020
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 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • No current intensive sports or physical activity practice. No current use of brain-training video games

Who cannot join

  • Dementia. Mild Cognitive Impairment. A neurological or major psychiatric disorder. Significant heart illness. Lung disease.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Department of Basic Psychology II (UNED)

    Madrid, 28040

Other trials in Spain

About this study

Official title: Protocol for a Randomized Controlled Trial With Active Control on the Effects of Combined Physical and Cognitive Training Versus Cognitive and Physical Training Separately on Executive Control and Memory Functions of Older Adults

Age-related cognitive decline affects negatively daily living and quality of life of older adults. Previous research has shown a moderate impact of cognitive and physical training on the cognitive functioning of elders. This randomized controlled trial (RCT) examines the differential impact of multi-domain cognitive (video game training) and physical training (the physical exercise was Body-attack, a mixed of dance, aerobic, strength, and muscular resistance versus cognitive training and physical training separately, on executive control and memory functions of healthy older adults (N=120), in comparison with an active control group. Participants (between 60 and 80 years old) will be allocated randomly to one of the four experimental groups: 1) physical training-single domain: physical training and cognitive control activity; 2) cognitive training-single domain: cognitive training and physical control activity; 3) cognitive-physical multi-domain: physical training and cognitive training; 4) active control: physical control activity and cognitive control activity. Physical training will be group-based and include coordination, aerobic exercise and strength exercise. The physical control activity will include stretching and relaxation exercises. The cognitive training will consist of commercial brain training video games. Difficulty will be automatically adjusted to the performance level of the participant. The cognitive control activity will be cognitively non-demanding video games. Physical activities (experimental and control) will be trained for 40 min and cognitive activities (experimental and control) for 40 min consecutively during the same session. There will be 2 session/wk over 3 months. Executive functioning, memory functions and psychological wellbeing will be assessed using behavioral and electrophysiological measures at baseline, after study completion and at 3-month follow-up. The main goal was to investigate possible intervention-related transfer effects to untrained executive and memory functions. The goal is to find out whether multi-domain training improves more executive and memory functions that are often compromised in later years, but essential for everyday activities. We expect to find larger transfer effects in the multi-domain condition than in the uni-domain conditions, shorter ERP latencies of the P2 component, and enhanced N2 and P3b components after training.

Read the detailed description

All participants complete one of the four combinations of cognitive training with video games and physical exercise. The cognitive component will be either a brain training video game program selected from Lumosity (cognitive intervention, CI) or video games not specifically designed to train attention and executive control (cognitive control, CC). The physical exercise component will be either Body-attack, a combination of dance, aerobic, strength, and muscular resistance (exercise intervention, EI) or its control condition composed of stretching, toning and relaxation (exercise control, EC).

Being tested
Cognitive training, Physical training, Cognitive control, Physical control
Keywords
Aging, geriatrics & gerontology, Video-game cognitive training, Dance, Physical exercise, Multi-domain training, Executive functions, Memory functions, Plasticity, Transfer, Follow-up intervention, Randomized controlled trial
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive trainingBehavioural

    Group-based cognitive training on iPads with commercially available video games (Lumosity) designed to enhance executive control, memory functions and processing speed. Difficulty will be automatically adjusted to the performance level of the participant. Participants will train for 40 min 2 days/wk over 3 months.

  • Physical trainingBehavioural

    Group-based fitness program (senior-friendly adaption of BodyAttack) that combines aerobic, strength and coordination training to a music soundtrack. Participants will train for 40 min, 2 days/wk over 3 months.

  • Cognitive controlBehavioural

    Group-based cognitive control activity consisting of playing on iPads non-cognitively demanding video games during 40 min 2 days/wk over 3 months and exercises based on relaxation and stretching for 40 min, 2 days/wk over 3 months.

  • Physical controlBehavioural

    Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.

Study groups in NCT03823183
Study groupRoleWhat they receive
Multi-domain trainingExperimentalGroup that receives cognitive training and physical training
Receives: Behavioral: Cognitive training; Behavioral: Physical training
Cognitive trainingExperimentalGroup that receives cognitive training and physical control activity
Receives: Behavioral: Cognitive training; Behavioral: Physical control
Physical activityExperimentalGroup that receives control cognitive activity and physical training
Receives: Behavioral: Physical training; Behavioral: Cognitive control
Active controlActive comparatorGroup that receives cognitive control activity and physical control activity
Receives: Behavioral: Cognitive control; Behavioral: Physical control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Executive functions assessed with Memory-based Task Switching

    Reaction time (RT) of correct responses in Memory-based Task Switching

    Measured: Change from Baseline in Memory-based Task Switching to 3 and 6 months

  2. Executive functions assessed with Memory-based Task Switching

    Performance in the Memory-base Task Switching: Neurophysiological parameter-Event-related potentials (ERPs) in the Memory-Based Task Switching

    Measured: Change from Baseline in Memory-based Task Switching to 3 and 6 months

  3. Attention assessed with Trail Making Test A+B

    Performance in Trail Making Test A+B score

    Measured: Change from Baseline in Trail Making Test to 3 and 6 months

  4. Inhibition assessed with Stroop Task

    Reaction time (RT) of correct responses in the Stroop Task

    Measured: Change from Baseline in Stroop Task to 3 and 6 months

  5. Working memory assessed with the N-back Task

    Hits-False Alarms in the N-back Task

    Measured: Change from Baseline in the N-Back Task to 3 and 6 months

  6. Immediate visual memory assessed with Visual Memory Face I (Weschler Memory Scale)

    Units on the Scale: scale range (minimum score = 0 and maximum score = 48).

    Measured: Change from Baseline in Face I to 3 and 6 months

  7. Differed visual memory assessed with Visual Memory Face II (Weschler Memory Scale)

    Units on the Scale: scale range (minimum score = 0 and maximum score = 48).

    With data from Visual Memory Face I (inmediate recognition) and Visual Memory Face II (differed recognition) we compute the percentage of memory retention = Visual Memory Face II / Visual Memory Face I X 100

    Measured: Change from Baseline in Face II to 3 and 6 months

  8. Immediate verbal memory assessed with Pair-Words I (Weschler Memory Scale)

    Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 32).

    Measured: Change from Baseline in Pair-Words I to 3 and 6 months

  9. Differed verbal memory assessed with Pair-Words II (Weschler Memory Scale)

    Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 8).

    scale range for Recognition (minimum score =0 and maximum score = 24)

    Recall. With data from Pair-Words I (inmediate recognition) and Pair-Words II (differed recognition) we compute the percentage of memory retention = Pair-Words II / Pair-Word I X 100

    Measured: Change from Baseline in Pair-Words II to 3 and 6 months

Secondary outcomes (7)
  1. Emotional and affective wellbeing assessed with Positive and Negative Affect Schedule (PANAS)

    Units on the Scale: 20 items Each item is evaluated between 0 (nothing) and 5 (many). Positive emotions are assessed with items: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19. Negative emotions are assessed with items: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20.

    Measured: Change from Baseline in PANAS to 3 and 6 months

  2. Emotional and affective wellbeing assessed with The Life Satisfaction Index (LSI): 20 items Each item is assessed using two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.

    Units on the Scale: 20 items A two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.

    Measured: Change from Baseline in LSI to 3 and 6 months

  3. Cardio-respiratory capacity assessed with the 6 Minutes Walk Test

    Physiological parameter

    Measured: Change from Baseline in 6 Minutes Walk Test to 3 and 6 months

  4. Physical dimension assessed with The Short Physical Performance Battery (SPPB)

    Units on the Scale

    Measured: Change from Baseline in SPPB to 3 and 6 months

  5. Demographic interview and medical history

    Respond to questions related to demographics and medical history

    Measured: Baseline

  6. General cognitive state assessed with Mini Mental State Examination (MMSE)

    Units on the test: scale range (minimum score = 0 and maximum score = 30). Values between 27 and 30 points are considered as "appropriate cognitive state".

    Values between 24 and 26 points are considered as "possible mild cognitive impairment" Values between 0 and 23 points are considered as "possible dementia". This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores under 27 will be excluded from the study.

    Measured: Baseline

  7. General depression state assessed with Yesavage Abbreviate Questionnaire. (GDS)

    Units on the test: scale range (minimum score = 0 and maximum score = 15). Values between 0 and 5 points are considered as "no depression". Values between 5 and 10 points are considered as "mild depression" Values between 10 and 15 points are considered as "severe depression". This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores greater than 5 will be excluded from the study.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Factorial
Model description
This study includes 4 intervention conditions: (1) Multi-modal Cognitive intervention + Physical intervention, (2) Cognitive intervention + Physical control, (3) Physical intervention + Cognitive control, and (4) Active Control group, Cognitive control + Physical control) x 3 (Time: Pretest, Post-test, 3-month follow-up) mixed factorial design, with "Type of training" as between-subject factors and "Time" as within-subject factor. The dependent variables will be behavioral and/or electrophysiological measures of executive functions (inhibition, shifting, working memory), memory functions (short term, episodic memory), and emotional well-being, quality of live and motivation.
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03823183
Sponsor's protocol ID
PSI2016-80377-R
Acronym
VIBAL
Status last verified
Jan 2019
First submitted
7 Jan 2019
Last updated
1 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ballesteros S, Rieker JA, Mayas J, Prieto A, Toril P, Jimenez MP, Reales JM. Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial. Trials. 2020 May 14;21(1):404. doi: 10.1186/s13063-020-04293-3.

    PubMed 32410715

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive training and Physical training in people with Executive Functions and Memory Functions, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

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 1 inclusion and 1 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 1 Feb 2019. 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 Spain. 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?

Executive functions assessed with Memory-based Task Switching (time frame: Change from Baseline in Memory-based Task Switching to 3 and 6 months). The study lists 9 primary outcomes in all. 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 NCT03823183, which also lists 1 linked publication.

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 1 Feb 2019.

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