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Clinical Trials/NCT05735405
NCT05735405RecruitingNot Applicable

Priming Effects of Aerobic Exercise on Cognitive Training of Patients With Ischemic and Hemorrhagic Stroke

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country30 target enrollmentStarted: November 12, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Neuropsychological test scores

Study Overview

Brief Summary

The goal of this clinical trial is to test the effects of aerobic exercise and BDNF on patients with ischemic and hemorrhagic stroke during a computerized cognitive training.

The main questions it aims to answer are:

  1. Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance?
  2. Is it possible to exploit the timing of rehabilitation interventions to obtain greater effects? Participants will be divided in 2 groups. The experimental group will first perform 20 minutes of pedaling as a moderate intensity aerobic exercise. It will then participate in one-hour cognitive training sessions, with the aim of training attentional, working memory and executive functions. The control group will carry out the same interventions but in reverse order.

The researchers will compare the results of the cognitive training in the two groups to verify if the order of the interventions influences the results themselves.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with a clinical diagnosis of stroke, both ischemic and haemorrhagic.
  • •Patients admitted to the Specialist Rehabilitation Unit 1 of the "E. Spalenza - Don Gnocchi "of Rovato.
  • •Overall score in the MoCA test ³ 26
  • •In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with score in the norm, P.E. > 1
  • •Hypertonic and spasticity picture compatible with the performance of motor activity of pedaling expected in the EA session.
  • •Tolerance of physical exercise
  • •Incoming electrocardiogram normal and free of anomalies

Exclusion Criteria

  • •Overall score in the MoCA test <26
  • •In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with pathological or borderline score, P.E. £
  • •Documented diagnosis of neurodegenerative diseases with impact on performance cognitive.
  • •Severe acquired brain injury
  • •Illiteracy
  • •Status of hypertonus and spasticity not compatible with the performance of motor training
  • •Excessive fatigue: the patient does not tolerate moderate intensity physical activity and accuses excessive fatigue during the preliminary test
  • •Electrocardiogram at entrance with anomalies and / or altered
  • •Ischemic heart disease
  • •Cardiac disorders that are contraindications for aerobic activity of moderate intensity

Arms & Interventions

Experimental Group

Experimental

The experimental group will first perform 30 minutes of pedaling as a moderate intensity aerobic activity. Subsequently it will carry out a daily cognitive training of 60 minutes to improve attentional, working memory and executive functions.

Intervention: Neuropsychological evaluation (Behavioral)

Experimental Group

Experimental

The experimental group will first perform 30 minutes of pedaling as a moderate intensity aerobic activity. Subsequently it will carry out a daily cognitive training of 60 minutes to improve attentional, working memory and executive functions.

Intervention: BDNF evaluation (Biological)

Experimental Group

Experimental

The experimental group will first perform 30 minutes of pedaling as a moderate intensity aerobic activity. Subsequently it will carry out a daily cognitive training of 60 minutes to improve attentional, working memory and executive functions.

Intervention: Pedaling as a moderate intensity aerobic exercise (Behavioral)

Experimental Group

Experimental

The experimental group will first perform 30 minutes of pedaling as a moderate intensity aerobic activity. Subsequently it will carry out a daily cognitive training of 60 minutes to improve attentional, working memory and executive functions.

Intervention: Cognitive Training (Other)

Experimental Group

Experimental

The experimental group will first perform 30 minutes of pedaling as a moderate intensity aerobic activity. Subsequently it will carry out a daily cognitive training of 60 minutes to improve attentional, working memory and executive functions.

Intervention: VO2 assessment (Diagnostic Test)

Control Group

Experimental

The control group will first carry out a daily 60-minute cognitive training to improve attentional, working memory and executive functions. It will then perform 30 minutes of pedaling as a moderate intensity aerobic activity.

Intervention: Neuropsychological evaluation (Behavioral)

Control Group

Experimental

The control group will first carry out a daily 60-minute cognitive training to improve attentional, working memory and executive functions. It will then perform 30 minutes of pedaling as a moderate intensity aerobic activity.

Intervention: BDNF evaluation (Biological)

Control Group

Experimental

The control group will first carry out a daily 60-minute cognitive training to improve attentional, working memory and executive functions. It will then perform 30 minutes of pedaling as a moderate intensity aerobic activity.

Intervention: Pedaling as a moderate intensity aerobic exercise (Behavioral)

Control Group

Experimental

The control group will first carry out a daily 60-minute cognitive training to improve attentional, working memory and executive functions. It will then perform 30 minutes of pedaling as a moderate intensity aerobic activity.

Intervention: Cognitive Training (Other)

Control Group

Experimental

The control group will first carry out a daily 60-minute cognitive training to improve attentional, working memory and executive functions. It will then perform 30 minutes of pedaling as a moderate intensity aerobic activity.

Intervention: VO2 assessment (Diagnostic Test)

Outcomes

Primary Outcomes

Neuropsychological test scores

Time Frame: Change in the neuropsychological test scores at 1 month

The experimental hypothesis is to obtain better scores in the experimental group on the neuropsychological tests used. T-tests and delta scores will be used to determine the quantitative change in the score.

Secondary Outcomes

  • Number of errors committed in the cognitive exercises(One month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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