Exercise the Mind and Brain. A Multimodal Intervention in Stroke

NCT04759950 | Completed

• 2 other identifiers: University of Barcelona201717.30.31.32
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke

Keywords

Neuroplasticity; stroke; neuroprotection; physical exercise; cognitive training; mindfulness; neuroimaging; intervention; randomization; blind

Outcome Measures

Primary Outcomes (8)

• Change in immediate verbal attention after receiving treatment

  Forward Digit Span (WAIS III)

  3 months (at baseline, 3 months from baseline)

• Change in verbal digit working memory after receiving treatment

  Backward Digit Span (WAIS III)

  3 months (at baseline, 3 months from baseline)

• Change in verbal memory after receiving treatment

  Rey Auditory Learning Test

  3 months (at baseline, 3 months from baseline)

• Change in visual memory after receiving treatment

  Rey's Complex Figure Test

  3 months (at baseline, 3 months from baseline)

• 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

  3 months (at baseline, 3 months from baseline)

• Change in executive function, inhibition after receiving treatment

  Stroop Test

  3 months (at baseline, 3 months from baseline)

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

  Trail Making Test

  3 months (at baseline, 3 months from baseline)

• Change in language, naming after receiving treatment

  Boston naming Test

  3 months (at baseline, 3 months from baseline)

Secondary Outcomes (15)

• Changes in psychological distress

  3 months (at baseline, 3 months from baseline)

• Changes in depression and anxiety

  3 months (at baseline, 3 months from baseline)

• Changes in wellbeing

  3 months (at baseline, 3 months from baseline)

• Changes in Mindfulness

  3 months (at baseline, 3 months from baseline)

• Changes in White matter integrity

  3 months (at baseline, 3 months from baseline)

Study Arms (3)

Physical exercise & cognitive training group

EXPERIMENTAL

The Physical exercise \& cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.

Behavioral: Multicomponent Physical Activity Program; Behavioral: Computerized Cognitive Training

Mindfulness & cognitive training group

EXPERIMENTAL

The Mindfulness \& cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.

Behavioral: Mindfulness-Based Stress Reduction Program; Behavioral: Computerized Cognitive Training

Cognitive training group

ACTIVE COMPARATOR

The Cognitive training group, as an active control group, receives only computer-based cognitive training.

Behavioral: Computerized Cognitive Training

Interventions

Multicomponent Physical Activity Program BEHAVIORAL

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).

Physical exercise & cognitive training group

Mindfulness-Based Stress Reduction Program BEHAVIORAL

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.

Mindfulness & cognitive training group

Computerized Cognitive Training BEHAVIORAL

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.

Cognitive training group; Mindfulness & cognitive training group; Physical exercise & cognitive training group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Claustrophobia
• Medical device (e.g., pacemaker implants, stents)
• Other metal objects in the body

Sponsors & Collaborators

• University of Barcelona: lead
• Fundació La Marató de TV3: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Institut Guttmann: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Maria Mataro

Barcelona, Spain

Location

Related Publications (2)

• 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.

  PMID: 40845631 DERIVED

• 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.

  PMID: 36248000 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Maria Mataro, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence is concealed (blinded) from research personnel, so that the investigators are not aware of whether a particular subject has been randomized to one of the intervention groups or to the active control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: February 18, 2021
• Study Start: October 28, 2020
• Primary Completion: July 30, 2021
• Study Completion: January 30, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)