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

NCT ID: NCT06596720

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-05-27

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.

Conditions

Aerobic Exercise; Chronic Stroke; Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

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.

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic Exercise

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emre BASKAN

OTHER

Sponsor Role: lead

Responsible Party

Emre BASKAN

Associate Proffesor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Pamukkale University

Denizli, Denizli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

60116787-020/46559

Identifier Type: -

Identifier Source: org_study_id