Aerobic Exercise and Cognitive Training in Patients With Stroke

February 9, 2023 updated by: Fondazione Don Carlo Gnocchi Onlus

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Brescia
      • Rovato, Brescia, Italy, 25038
        • Recruiting
        • Centro Ettore Spalenza- Fondazione Don Gnocchi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Massimiliano Gobbo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. £ 1.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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.
Behavioral: Neuropsychological evaluation
Each participant will undergo a complete neuropsychological evaluation, both before and at the end of the clinical trial, with the aim of detecting any changes or improvements.
Biological: BDNF evaluation
During the first and last clinical trial session, each participant will undergo two blood samples, one before and one at the end of the ride, to check levels of Brain Derived Neurotrophic Factor (BDNF).
Behavioral: Pedaling as a moderate intensity aerobic exercise
During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity.
Other: Cognitive Training
During each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions.
Diagnostic test: VO2 assessment

To determine the individual moderate intensity for each patient, a VO2 consumption assessment will be made. The examination will be carried out using an exercise bike and a mask for the calculation of metabolic oxygen consumption.

The 3 MET threshold to reach in pedaling will be calculated (to define it of moderate intensity), in order to elicit the release of BDNF.
Experimental: Control Group
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.
Behavioral: Neuropsychological evaluation
Each participant will undergo a complete neuropsychological evaluation, both before and at the end of the clinical trial, with the aim of detecting any changes or improvements.
Biological: BDNF evaluation
During the first and last clinical trial session, each participant will undergo two blood samples, one before and one at the end of the ride, to check levels of Brain Derived Neurotrophic Factor (BDNF).
Behavioral: Pedaling as a moderate intensity aerobic exercise
During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity.
Other: Cognitive Training
During each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions.
Diagnostic test: VO2 assessment

To determine the individual moderate intensity for each patient, a VO2 consumption assessment will be made. The examination will be carried out using an exercise bike and a mask for the calculation of metabolic oxygen consumption.

The 3 MET threshold to reach in pedaling will be calculated (to define it of moderate intensity), in order to elicit the release of BDNF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in the neuropsychological test scores at 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of errors committed in the cognitive exercises
Time Frame: One month
For each exercise used in the cognitive training, numerical data will be extrapolated to determine the number of errors committed and the progress achieved. T-tests will be carried out to verify if the experimental group had a better performance during the training than the control group.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1; 01/09/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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