NCT06596720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

August 23, 2024

Last Update Submit

September 11, 2024

Conditions

Keywords

aerobic exercisechronic strokecognitive function

Outcome Measures

Primary Outcomes (3)

  • 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.

    10 minutes

  • Wechsler Forward Digit Span, Wechsler Backward Digit Span

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

    10 minutes

  • CancellationTest

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

    5 minutes

Other Outcomes (3)

  • Saturation

    5 minutes

  • Pulse values

    5 minutes

  • Systolic and diastolic blood pressure

    5 minutes

Study Arms (2)

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.

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

Interventions

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

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Denizli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

August 23, 2024

First Posted

September 19, 2024

Study Start

September 15, 2020

Primary Completion

May 2, 2021

Study Completion

May 27, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations