Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-03 @ 2:20 PM
Study NCT ID:
NCT06596720
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Aerobic Exercise on Cognitive Functions in Patients with Chronic Stroke
Sponsor:
Emre BASKAN
Organization:
Study Overview
Official Title:
Evaluating the Immediate Impact of Aerobic Exercise on Cognitive Function in Individuals Affected by Chronıc Stroke
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this observational study is to investigate the acute effects of aerobic exercise on cognitive functions in patients with chronic stroke. The primary question addressed is:
Does aerobic exercise have an impact on cognitive functions in individuals with chronic stroke? Participants with chronic stroke were divided into two groups: those engaging in aerobic exercise and a control group. Both groups underwent cognitive function assessments at intervals of thirty minutes.
Does aerobic exercise have an impact on cognitive functions in individuals with chronic stroke? Participants with chronic stroke were divided into two groups: those engaging in aerobic exercise and a control group. Both groups underwent cognitive function assessments at intervals of thirty minutes.
Detailed Description:
WORKPLACE The study was conducted at the Department of Neurological Rehabilitation, Faculty of Physiotherapy and Rehabilitation, Pamukkale University.
PARTICIPANTS The study included 38 stroke patients admitted to Pamukkale University Hospital, aged between 25 and 80, who had a diagnosed cardiopulmonary disease or additional neurological disorders, and did not have defined psychological issues. Individuals with visual or auditory impairments were excluded from the study. Participants were informed about the study, provided with a voluntary information form to read, and written consent was obtained.
In this study, a bicycle ergometer was used considering the safety and individual capabilities of the participants. The protocol consisted of a 5-minute warm-up, 20 minutes of moderate-intensity exercise, and a 5-minute cool-down period. While most studies aim for high-intensity exercise (60-80%), this study focused on a single-session exercise training model; hence, the exercise program for the study group was set at a moderate intensity (40-50%). Participants in the study group wore a pulse oximeter and were instructed to exercise within the specified heart rate ranges. Neuropsychological tests were administered before and after the bicycle ergometer sessions. The control group underwent neuropsychological tests at thirty-minute intervals without using the bicycle ergometer.
REGISTRATION FORM The registration form collected information on demographic data, including the date of stroke onset, medical history, family history, smoking and alcohol use, dominant and affected extremities, and current comorbidities.
ASSESSMENT Participants were randomly assigned to the study or control group using a closed-envelope method. All assessments were conducted in a well-lit and quiet room. Cognitive levels were measured using the Standardized Mini-Mental State Test (SMMT). In the study group, blood pressure, pulse, and oxygen saturation were measured. Subsequently, the Stroop Test T-BAG Form, Letter Cancellation Test, and Wechsler Digit Span Test were administered. After the tests, a thirty-minute submaximal bicycle ergometer session, including a 5-minute warm-up and a 5-minute cool-down period, was conducted. Blood pressure, pulse, and oxygen saturation were measured again, and the tests were repeated. In the control group, blood pressure, pulse, and oxygen saturation were measured before administering the Stroop Test, Letter Cancellation Test, and Wechsler Digit Span Test. To avoid learning effects in the neuropsychological test battery, participants in the control group waited for approximately thirty minutes before repeating cognitive tests, and results were recorded.
PARTICIPANTS The study included 38 stroke patients admitted to Pamukkale University Hospital, aged between 25 and 80, who had a diagnosed cardiopulmonary disease or additional neurological disorders, and did not have defined psychological issues. Individuals with visual or auditory impairments were excluded from the study. Participants were informed about the study, provided with a voluntary information form to read, and written consent was obtained.
In this study, a bicycle ergometer was used considering the safety and individual capabilities of the participants. The protocol consisted of a 5-minute warm-up, 20 minutes of moderate-intensity exercise, and a 5-minute cool-down period. While most studies aim for high-intensity exercise (60-80%), this study focused on a single-session exercise training model; hence, the exercise program for the study group was set at a moderate intensity (40-50%). Participants in the study group wore a pulse oximeter and were instructed to exercise within the specified heart rate ranges. Neuropsychological tests were administered before and after the bicycle ergometer sessions. The control group underwent neuropsychological tests at thirty-minute intervals without using the bicycle ergometer.
REGISTRATION FORM The registration form collected information on demographic data, including the date of stroke onset, medical history, family history, smoking and alcohol use, dominant and affected extremities, and current comorbidities.
ASSESSMENT Participants were randomly assigned to the study or control group using a closed-envelope method. All assessments were conducted in a well-lit and quiet room. Cognitive levels were measured using the Standardized Mini-Mental State Test (SMMT). In the study group, blood pressure, pulse, and oxygen saturation were measured. Subsequently, the Stroop Test T-BAG Form, Letter Cancellation Test, and Wechsler Digit Span Test were administered. After the tests, a thirty-minute submaximal bicycle ergometer session, including a 5-minute warm-up and a 5-minute cool-down period, was conducted. Blood pressure, pulse, and oxygen saturation were measured again, and the tests were repeated. In the control group, blood pressure, pulse, and oxygen saturation were measured before administering the Stroop Test, Letter Cancellation Test, and Wechsler Digit Span Test. To avoid learning effects in the neuropsychological test battery, participants in the control group waited for approximately thirty minutes before repeating cognitive tests, and results were recorded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: