Clinical trial NCT06596720: Acute Effects of Aerobic Exercise on Cognitive Functions in Patients with Chronic Stroke
Official title: Evaluating the Immediate Impact of Aerobic Exercise on Cognitive Function in Individuals Affected by Chronıc Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerobic Exercise
Chronic Stroke
Cognitive Function
Keywords: aerobic exercise
chronic stroke
cognitive function
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stroop tests
timeFrame: 10 minutes
measure: Wechsler Forward Digit Span, Wechsler Backward Digit Span
timeFrame: 10 minutes
measure: CancellationTest
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
measure: Saturation
timeFrame: 5 minutes
measure: Pulse values
timeFrame: 5 minutes
measure: Systolic and diastolic blood pressure
timeFrame: 5 minutes
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: