Aerobic Exercise and Cognitive Training in Patients With Stroke

Not Applicable

Recruiting

• Conditions: Hemorrhagic Stroke; Ischemic Stroke
• Interventions: Behavioral: Neuropsychological evaluation; Biological: BDNF evaluation; Behavioral: Pedaling as a moderate intensity aerobic exercise; Other: Cognitive Training; Diagnostic Test: VO2 assessment

• Registration Number: NCT05735405
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-11-04
• Study Start: 2022-11-12
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Neuropsychological evaluation	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.
Experimental Group	BDNF evaluation	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.
Experimental Group	VO2 assessment	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.
Control Group	Pedaling as a moderate intensity aerobic exercise	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.
Experimental Group	Cognitive Training	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.
Control Group	BDNF evaluation	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.
Control Group	VO2 assessment	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.
Experimental Group	Pedaling as a moderate intensity aerobic exercise	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.
Control Group	Neuropsychological evaluation	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.
Control Group	Cognitive Training	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.

Primary Outcome Measures

Name	Time	Method
Neuropsychological test scores	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 Outcome Measures

Name	Time	Method
Number of errors committed in the cognitive exercises	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.

Trial Locations

Locations (1)

Centro Ettore Spalenza- Fondazione Don Gnocchi; 🇮🇹 Rovato, Brescia, Italy