Aerobic ExerciseNCT06596720
Acute Effects of Aerobic Exercise on Cognitive Functions in Patients with Chronic Stroke
A study testing Aerobic Exercise in people with Aerobic Exercise and Chronic Stroke, run by Emre BASKAN at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Aerobic Exercise, Chronic Stroke, Cognitive Function
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 27 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having experienced an ischemic or hemorrhagic stroke
- Having been diagnosed with a stroke at least six months prior
- Having not experienced multiple stroke episodes
- Having no communication difficulties
- Being literate
Who cannot join
- Having hearing loss
- Receiving additional treatment beyond rehabilitation
- Using a pacemaker
- Presence of cardio-pulmonary disease
- Having experienced a recent trauma
- Having additional neurological disorders aside from stroke
- Having a psychological disorder
- Having a pre-existing condition that affects cognitive level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Immediate Impact of Aerobic Exercise on Cognitive Function in Individuals Affected by Chronıc Stroke
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.
Read the 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.
- Conditions
- Aerobic Exercise, Chronic Stroke, Cognitive Function
- Being tested
- Aerobic Exercise
- Keywords
- aerobic exercise, chronic stroke, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
After the initial assessments of the individuals in the study group were completed, the exercise program was implemented. The exercise program consisted of 30 minutes of submaximal cycling using the Karvonen formula. The aerobic exercise program was structured with a 5-minute warm-up, a 5-minute cool-down, and the remaining time dedicated to the exercise phase. Since our study included only a single exercise session, a moderate-intensity training program was applied to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Cognitive assessments for participants in the study group were conducted using the Standardized Mini-Mental State Test, Stroop Test T-BAG Form, Wechsler Digit Span subtest, and Letter Cancellation Test. Participants underwent a thirty-minute session on a moderate-intensity bicycle ergometer. Subsequently, pulse, oxygen saturation, and blood pressure were measured, and the Stroop Test T-BAG Form, Wechsler Digit Span Tests, and Letter Cancellation Tests were repeated. Receives: Other: Aerobic Exercise |
| Control group | No intervention | Cognitive assessments for participants in the control group were conducted using the Standardized Mini-Mental State Test, Stroop Test T-BAG Form, Wechsler Digit Span subtest, and Letter Cancellation Test. The control group was left in a quiet room for thirty minutes. After this period, pulse, oxygen saturation, and blood pressure were measured, and the Stroop Test T-BAG Form, Wechsler Digit Span Tests, and Letter Cancellation Tests were repeated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop tests
This test is a brief measure of selective or focused attention, specifically assessing the ability to shift from one perceptual state to another and suppress response tendencies.
Measured: 10 minutes
Wechsler Forward Digit Span, Wechsler Backward Digit Span
This test is used to assess attention and short-term memory.
Measured: 10 minutes
CancellationTest
This test measures sustained attention, visual scanning, reaction time, and response impulsivity.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2020
- Primary completion2 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For cognitive assessments of the individuals, the Standardized Mini-Mental State Examination, Stroop Test, T-BAG form, Wechsler Digit Span subtest, and Letter Cancellation Test were used. The individuals with stroke in the study group underwent 30 minutes of moderate-intensity cycling on a cycle ergometer. The individuals with stroke in the control group were left in a quiet room for 30 minutes. After this period, both groups had their pulse, saturation, and blood pressure measured again, and the Stroop Test T-BAG Form, Wechsler Digit Span Tests, and Letter Cancellation Tests were repeated.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emre BASKAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre BASKAN, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596720
- Sponsor's protocol ID
- 60116787-020/46559
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Immediate Impact of Aerobic Exercise on Cognitive Function in Individuals Affected by Chronıc Stroke
- ClinicalTrials.gov ID
- NCT06596720
- Acronym / sponsor ID
- 60116787-020/46559
- Conditions
- Aerobic Exercise, Chronic Stroke, Cognitive Function
- Keywords
- aerobic exercise, chronic stroke, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Emre BASKANUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- For cognitive assessments of the individuals, the Standardized Mini-Mental State Examination, Stroop Test, T-BAG form, Wechsler Digit Span subtest, and Letter Cancellation Test were used. The individuals with stroke in the study group underwent 30 minutes of moderate-intensity cycling on a cycle ergometer. The individuals with stroke in the control group were left in a quiet room for 30 minutes. After this period, both groups had their pulse, saturation, and blood pressure measured again, and the Stroop Test T-BAG Form, Wechsler Digit Span Tests, and Letter Cancellation Tests were repeated.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Aerobic ExerciseCognitive assessments for participants in the study group were conducted using the Standardized Mini-Mental State Test, Stroop Test T-BAG Form, Wechsler Digit Span subtest, and Letter Cancellation Test. Participants underwent a thirty-minute session on a moderate-intensity bicycle ergometer. Subsequently, pulse, oxygen saturation, and blood pressure were measured, and the Stroop Test T-BAG Form, Wechsler Digit Span Tests, and Letter Cancellation Tests were repeated. |
| Control group | No intervention | –Cognitive assessments for participants in the control group were conducted using the Standardized Mini-Mental State Test, Stroop Test T-BAG Form, Wechsler Digit Span subtest, and Letter Cancellation Test. The control group was left in a quiet room for thirty minutes. After this period, pulse, oxygen saturation, and blood pressure were measured, and the Stroop Test T-BAG Form, Wechsler Digit Span Tests, and Letter Cancellation Tests were repeated |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having experienced an ischemic or hemorrhagic stroke
- Having been diagnosed with a stroke at least six months prior
- Having not experienced multiple stroke episodes
- Having no communication difficulties
- Being literate
Key exclusion criteria (8 listed)
- Having hearing loss
- Receiving additional treatment beyond rehabilitation
- Using a pacemaker
- Presence of cardio-pulmonary disease
- Having experienced a recent trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAfter the initial assessments of the individuals in the study group were completed, the exercise program was implemented. The exercise program consisted of 30 minutes of submaximal cycling using the Karvonen formula. The aerobic exercise program was structured with a 5-minute warm-up, a 5-minute cool-down, and the remaining time dedicated to the exercise phase. Since our study included only a single exercise session, a moderate-intensity training program was applied to the participants. | Other | Study group |
Primary outcome
Stroop tests
Time frame: 10 minutes
This test is a brief measure of selective or focused attention, specifically assessing the ability to shift from one perceptual state to another and suppress response tendencies.
Wechsler Forward Digit Span, Wechsler Backward Digit Span
Time frame: 10 minutes
This test is used to assess attention and short-term memory.
CancellationTest
Time frame: 5 minutes
This test measures sustained attention, visual scanning, reaction time, and response impulsivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Aerobic Exercise
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruiting
Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Aerobic Exercise and Chronic Stroke, run by Emre BASKAN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop tests (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.