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Completed

NCT Number: NCT06596720

Acute Effects of Aerobic Exercise on Cognitive Functions in Patients with Chronic 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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

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.

Primary outcomes

  1. 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.

  2. Wechsler Forward Digit Span, Wechsler Backward Digit Span

    Time frame: 10 minutes

    This test is used to assess attention and short-term memory.

  3. CancellationTest

    Time frame: 5 minutes

    This test measures sustained attention, visual scanning, reaction time, and response impulsivity.

Other outcomes

  1. Saturation

    Time frame: 5 minutes

    Oxygen saturation indicates the normal level of oxygen transported to tissues. It is a key indicator, especially for monitoring cardiopulmonary health.

  2. Pulse values

    Time frame: 5 minutes

    The total number of systolic contractions of the heart per minute is referred to as the heart rate (HR), also known as the pulse.

  3. Systolic and diastolic blood pressure

    Time frame: 5 minutes

    Blood pressure refers to the force exerted by blood on the inner walls of the arteries. It is one of the most fundamental indicators of a person's health. During ventricular systole, blood is ejected into the arteries, reaching its peak pressure, known as systolic pressure. During ventricular diastole, blood is drawn back, and the pressure falls to its lowest level, known as diastolic pressure.

Sponsors and collaborators

Lead sponsor

Emre BASKAN

Other

Registry information

Official study title

Evaluating the Immediate Impact of Aerobic Exercise on Cognitive Function in Individuals Affected by Chronıc Stroke

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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