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Aerobic Exercise and Cognitive Training in Patients With Stroke

Primary Purpose

Ischemic Stroke, Hemorrhagic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Neuropsychological evaluation
BDNF evaluation
Pedaling as a moderate intensity aerobic exercise
Cognitive Training
VO2 assessment
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ischemic Stroke focused on measuring BDNF, Aerobic Exercise, Cognitive Training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Ettore Spalenza- Fondazione Don GnocchiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Neuropsychological test scores
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 Outcome Measures

Number of errors committed in the cognitive exercises
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.

Full Information

First Posted
November 4, 2022
Last Updated
February 9, 2023
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT05735405
Brief Title
Aerobic Exercise and Cognitive Training in Patients With Stroke
Official Title
Priming Effects of Aerobic Exercise on Cognitive Training of Patients With Ischemic and Hemorrhagic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hemorrhagic Stroke
Keywords
BDNF, Aerobic Exercise, Cognitive Training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Neuropsychological evaluation
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
BDNF evaluation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Pedaling as a moderate intensity aerobic exercise
Intervention Description
During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity.
Intervention Type
Other
Intervention Name(s)
Cognitive Training
Intervention Description
During each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions.
Intervention Type
Diagnostic Test
Intervention Name(s)
VO2 assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuropsychological test scores
Description
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.
Time Frame
Change in the neuropsychological test scores at 1 month
Secondary Outcome Measure Information:
Title
Number of errors committed in the cognitive exercises
Description
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.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centro Ettore Spalenza- Fondazione Don Gnocchi
City
Rovato
State/Province
Brescia
ZIP/Postal Code
25038
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Redolfi
Phone
+039 030/7245419
Email
aredolfi@dongnocchi.it
First Name & Middle Initial & Last Name & Degree
Valentina Beccati
Email
vbeccati@dongnocchi.it
First Name & Middle Initial & Last Name & Degree
Massimiliano Gobbo

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Aerobic Exercise and Cognitive Training in Patients With Stroke

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