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StrokeMindfitNCT04759950

Exercise the Mind and Brain. A Multimodal Intervention in Stroke

A study testing Multicomponent Physical Activity Program, Mindfulness-Based Stress Reduction Program and Computerized Cognitive Training in people with Stroke, run by University of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of MindFit Project is to develop an evidence-based multimodal investigation of combined non-pharmacological strategies in chronic stroke patients and clarify the neuroplasticity mechanisms underlying the benefits of physical exercise and mindfulness strategies combined with cognitive training on… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Multicomponent Physical Activity Program, Mindfulness-Based Stress Reduction Program and Computerized Cognitive Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
1 siteSpain
Study dates
28 Oct 2020to 30 Jan 2022
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals aged 18-80 years old
  • Ischemic or hemorrhagic stroke
  • Stroke diagnoses between 3-60 months ago
  • To have consent from a physician to engage in an exercise intervention
  • Fluency in Catalan or Spanish (I.e., able to understand and speak)
  • Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.

Who cannot join

  • Cognitive impairment (MMSE > 23)
  • Severe aphasia (item 9 of the NIHSS scale ≥ 2)
  • Severe sensory problems
  • Other neurological conditions apart from stroke
  • Severe pre-stroke psychiatric disorders (e.g., bipolar disorder, schizophrenia)
  • History of alcohol or other toxic abuse
Show all 9Show fewer
  • Claustrophobia
  • Medical device (e.g., pacemaker implants, stents)
  • Other metal objects in the body

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Maria Mataro

    Barcelona

Other trials in Spain

About this study

Official title: Effects of Combined Therapies of Physical Exercise, Mindfulness and Cognitive Stimulation on Cognition and Neuroplasticity in Chronic Stroke Patients: A Randomized Controlled Trial

The main objective of MindFit Project is to develop an evidence-based multimodal investigation of combined non-pharmacological strategies in chronic stroke patients and clarify the neuroplasticity mechanisms underlying the benefits of physical exercise and mindfulness strategies combined with cognitive training on post-stroke recovery. The investigators have adopted a multidisciplinary and multimodal approach to provide a more integrative perspective using cognitive, social-psychological, biochemical, and neuroimaging measurements.

Read the detailed description

The MindFit Project is a multicentric, prospective, parallel, single-blinded, randomized controlled trial with a sample of 141 participants at 3 to 60 months after stroke. Participants are randomly allocated to one of three arms (through a simple randomizing procedure with a 1:1:1 ratio created with a random sequence generator software).

The first group (n=47) receives computer-based cognitive training (CCT) combined with a multicomponent physical exercise program. The second group (n=47) receives CCT combined with mindfulness-based stress reduction therapy. Finally, the third group (n=47), as an active control group, receives only CCT. All interventions last 12 weeks.

Within two weeks before the start of the interventions, and again at 3 months after completing the interventions, medical, cognitive, and physical assessments, neuroimaging, and biological samples collection are performed.

The objectives of this project are:

  1. To examine the effects of multimodal interventions in a population of chronic stroke patients on various domains: cognition, emotion, physical health, and quality of life.
  2. To examine specific plasticity effects of each of the three interventions regarding structural and functional magnetic resonance imaging (MRI) and how these changes may contribute to cognitive and emotional benefits.
  3. To study the molecular mechanisms by which the different types of interventions influence cognitive, emotional and brain benefits.
  4. To study interventions-induced microbiome changes and to explain how these changes may induce inflammatory and immune responses that may contribute to cognitive, emotional and brain benefits.
  5. To determine the demographic, clinical and genetic factors that may modulate cognitive, emotional and brain changes: baseline cognitive status; baseline cerebral status (atrophy, total intracranial volume); sex; age, educational level, intelligence.
Conditions
Stroke
Being tested
Multicomponent Physical Activity Program, Mindfulness-Based Stress Reduction Program, Computerized Cognitive Training
Keywords
Neuroplasticity, stroke, neuroprotection, physical exercise, cognitive training, mindfulness, neuroimaging, intervention, randomization, blind
Medical subject headings
Stroke, Motor Activity

What participants receive

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

  • Multicomponent Physical Activity ProgramBehavioural

    The proposed physical exercise intervention follows the American College of Sports Medicine (ACSM, 2017) and the American Stroke Association (Billinger et al., 2014) recommendations for stroke patients. The five weekly 45-minute sessions are divided into (1) three sessions guided and supervised telematically by a physical exercise specialist and a physiotherapist; (2) and two autonomous exercise sessions. The supervised sessions include exercises to work aerobic capacity, muscle strength and endurance, flexibility, agility, and balance. The intensity of these exercises is prescribed individually according to each participant's initial level and are gradually increased as the program progresses. Participants are encouraged to walk at a similar intensity on autonomous physical exercise days as performed in the guided sessions (moderate intensity), based on the Borg scale of perceived exertion (Borg, 1982).

  • Mindfulness-Based Stress Reduction ProgramBehavioural

    This intervention follows an adaptation of the scheme and instructions of the official Mindfulness-Based Stress Reduction (MBSR) program designed by Jon Kabat-Zinn. It includes body scanning, sitting meditation, and gentle hatha yoga techniques. An accredited mindfulness instructor leads the 12-week online program, which comprises a presentation session, followed by eight intervention sessions (once a week, lasting 2.5 hours) and an intensive practice session interspersed between sessions six and seven. Apart from the supervised session, the therapist asks participants to carry out some independent practice daily.

  • Computerized Cognitive TrainingBehavioural

    An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform. The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.

Study groups in NCT04759950
Study groupRoleWhat they receive
Physical exercise & cognitive training groupExperimentalThe Physical exercise \& cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.
Receives: Behavioral: Multicomponent Physical Activity Program; Behavioral: Computerized Cognitive Training
Mindfulness & cognitive training groupExperimentalThe Mindfulness \& cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.
Receives: Behavioral: Mindfulness-Based Stress Reduction Program; Behavioral: Computerized Cognitive Training
Cognitive training groupActive comparatorThe Cognitive training group, as an active control group, receives only computer-based cognitive training.
Receives: Behavioral: Computerized Cognitive Training

What is being measured

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

  1. Change in immediate verbal attention after receiving treatment

    Forward Digit Span (WAIS III)

    Measured: 3 months (at baseline, 3 months from baseline)

  2. Change in verbal digit working memory after receiving treatment

    Backward Digit Span (WAIS III)

    Measured: 3 months (at baseline, 3 months from baseline)

  3. Change in verbal memory after receiving treatment

    Rey Auditory Learning Test

    Measured: 3 months (at baseline, 3 months from baseline)

  4. Change in visual memory after receiving treatment

    Rey's Complex Figure Test

    Measured: 3 months (at baseline, 3 months from baseline)

  5. Change in executive function, verbal fluency after receiving treatment

    Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal

    Measured: 3 months (at baseline, 3 months from baseline)

  6. Change in executive function, inhibition after receiving treatment

    Stroop Test

    Measured: 3 months (at baseline, 3 months from baseline)

  7. Change in executive function, set-switching task after receiving treatment

    Trail Making Test

    Measured: 3 months (at baseline, 3 months from baseline)

  8. Change in language, naming after receiving treatment

    Boston naming Test

    Measured: 3 months (at baseline, 3 months from baseline)

Secondary outcomes (15)

  1. Changes in psychological distress

    Clinical Outcomes in Routine Evaluation (CORE-OM)

    Measured: 3 months (at baseline, 3 months from baseline)

  2. Changes in depression and anxiety

    Depression Anxiety Stress Scale (DASS-21)

    Measured: 3 months (at baseline, 3 months from baseline)

  3. Changes in wellbeing

    Ryff Scales of Psychological Wellbeing.

    Measured: 3 months (at baseline, 3 months from baseline)

  4. Changes in Mindfulness

    Mindful Attention Awareness Scale (MAAS)

    Measured: 3 months (at baseline, 3 months from baseline)

  5. Changes in White matter integrity

    White matter integrity: tractography

    Measured: 3 months (at baseline, 3 months from baseline)

  6. Changes in Resting-state connectivity

    Resting state brain activity using fMRI

    Measured: 3 months (at baseline, 3 months from baseline)

  7. Changes in brain volumetry

    Grey and white matter volume measured by MRI

    Measured: 3 months (at baseline, 3 months from baseline)

  8. Molecular changes: growth factors (BDNF, SDF1-a, VEGF-A, IGF-1, and NGF), cortisol, protein C reactive, IL-6 and homocysteine levels

    Quantification of different biomarkers from blood samples.

    Measured: 3 months (at baseline, 3 months from baseline)

  9. Changes in Microbiota data

    Bacterial composition of stool samples in terms of relative abundance

    Measured: 3 months (at baseline, 3 months from baseline)

  10. Changes in Sleep

    Pittsburgh Sleep Quality Index (PSQI)

    Measured: 3 months (at baseline, 3 months from baseline)

  11. Changes in Fitness

    Senior Fitness Test (SFT)

    Measured: 3 months (at baseline, 3 months from baseline)

  12. Changes in stroke specific quality of life

    Stroke-specific Quality of Life Scale (ECVI-38)

    Measured: 3 months (at baseline, 3 months from baseline)

  13. Changes in quality of life

    World Health Organization Quality of Life (WHOQOL-BREF)

    Measured: 3 months (at baseline, 3 months from baseline)

  14. Changes in mental fatigue

    Fatigue Assessment Scale (FAS)

    Measured: 3 months (at baseline, 3 months from baseline)

  15. Changes in physical activity:

    Spanish version of the reduced Minnesota leisure-time physical and activity questionnaire (VREM)

    Measured: 3 months (at baseline, 3 months from baseline)

Timeline

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

  1. First posted18 Feb 2021
  2. Study start28 Oct 2020
  3. Primary completion30 Jul 2021
  4. Study completion30 Jan 2022

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
141 participants at 3 to 60 months after stroke are randomly allocated to one of three arms: The first group (n=47) receives computer-based cognitive training (CCT) combined with a multicomponent physical exercise program. The second group (n=47) receives CCT combined with mindfulness-based stress reduction therapy. Finally, the third group (n=47), as an active control group, receives only CCT.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04759950
Sponsor's protocol ID
University of Barcelona
Other IDs
201717.30.31.32
Acronym
Mindfit
Status last verified
Mar 2022
First submitted
31 Dec 2020
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bermudo-Gallaguet A, Ariza M, Agudelo D, Camins-Vila N, Boldo M, Ferrer-Uris B, Busquets A, Pera G, Caceres C, Gomis M, Dacosta-Aguayo R, Clemente IC, Garcia-Molina A, Mata MJD, Toran-Monserrat P, Erickson KI, Mataro M. Effects of mindfulness and exercise on cognition and emotion in adults with mild deficits in the chronic post-stroke phase: A randomized controlled trial. Ann Phys Rehabil Med. 2025 Oct;68(7):102008. doi: 10.1016/j.rehab.2025.102008. Epub 2025 Aug 21.

    PubMed 40845631

  • Bermudo-Gallaguet A, Ariza M, Dacosta-Aguayo R, Agudelo D, Camins-Vila N, Boldo M, Carrera O, Vidal S, Ferrer-Uris B, Busquets A, Via M, Pera G, Caceres C, Gomis M, Garcia-Molina A, Tormos JM, Arrabe A, Diez G, Dura Mata MJ, Toran-Monserrat P, Soriano-Raya JJ, Domenech S, Perera-Lluna A, Erickson KI, Mataro M. Effects and mechanisms of mindfulness training and physical exercise on cognition, emotional wellbeing, and brain outcomes in chronic stroke patients: Study protocol of the MindFit project randomized controlled trial. Front Aging Neurosci. 2022 Sep 29;14:936077. doi: 10.3389/fnagi.2022.936077. eCollection 2022.

    PubMed 36248000

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent Physical Activity Program, Mindfulness-Based Stress Reduction Program and Computerized Cognitive Training in people with Stroke, run by University of Barcelona 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 6 inclusion and 9 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 2 Mar 2022. 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?

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?

Change in immediate verbal attention after receiving treatment (time frame: 3 months (at baseline, 3 months from baseline)). The study lists 8 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 NCT04759950, which also lists 2 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 2 Mar 2022.

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