Effects of Aerobic Exercise During the Early Rehabilitation After Ischemic Stroke

NCT ID: NCT05690165

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2024-02-01

Brief Summary

The goal of this clinical trial is to study the effects of aerobic exercise during the early rehabilitation after ischemic stroke. The main questions it aims to answer are:

• How is the recovery of motor function affected by regularly walking during the first 90 days after an ischemic stroke?
• Does regularly walking during the first 90 days after ischemic stroke affect cognition, physical comfort and the immune system? Participants will exert a heart rate controlled walking programme of walking 3-5 times 30-45 minutes per week. Researchers will compare the recovery of the walking group to a control group without any demands regarding physical exercise.

Detailed Description

From animal experiments we know that wheel running has a positive impact on functional recovery after experimental stroke. We aim to translate this observations from our animal experiments into the clinic. Therefore, patients will be included shortly after ischemic stroke and start an aerobic exercise programme during the first 14 days after the event. At baseline visit the participants receive a neuropsychological testing with the focus on cognition, fatigue and depressive symptoms. Furthermore, we perform blood sampling for analysis of the activation state of the peripheral immune system. The patients receive a lactate ergometry with measurement of the 3 mmol lactate threshold to define the optimal heart rate range for their walking exercise. We perform the fugl-meyer assessment for the upper and the lower extremity.

For correlation with training-induced structural changes participants receive cerebral magnetic resonance imaging to assess the density of axonal fibre tracts (assessed by MRI-DTI). During the following 90 days participants in the intervention group are instructed to walk 3-5 times for 30-45 minutes per week and control the exercise intensity by optical heart rate measurement via smartwatch. The daily step count will be protocolled by the intervention and the control group. Participants will measure their resting heart rate in the morning before getting up to prevent overexercising. The assessments of the baseline visit will be repeated after 90 days.

Conditions

Ischemic Stroke; Stroke Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Exercise Group

Participants will exert a heart rate controlled aerobic walking training 3-5 times per week for 30-45 minutes per training. This exercise as well as the daily amount of steps will be assessed via smartwatch.

Group Type: EXPERIMENTAL

Walking Exercise

Intervention Type: BEHAVIORAL

Heart rate controlled walking exercise

No Exercise Group

Participants receive no demands regarding the daily exercise. Their daily amount of steps will be assessed via smartwach.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Walking Exercise

Heart rate controlled walking exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• initial NIHSS or NIHSS determined at the moment of maximum deterioration 1-18
• age > 18
• ischemic stroke
• pre-stroke independence
• sufficient motivation / patient's desire to cooperate / exercise for 3-5x/week for 30-45 min

Exclusion Criteria

• transient ischemic attack
• premorbid motor disability / musculoskeletal injury / severe arthritis impairing degree of movement
• balance and transfer function that requires assistance
• cardiac disease not allowing to perform aerobic training
• inability to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antje Schmidt-Pogoda, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

University Hospital Münster

Münster, Northrine-Westphalia, Germany

Countries

Germany

References

Straeten FA, van Zyl S, Maus B, Bauer J, Raum H, Gross CC, Bruchmann S, Landmeyer NC, Faber C, Minnerup J, Schmidt-Pogoda A. EXERTION: a pilot trial on the effect of aerobic, smartwatch-controlled exercise on stroke recovery: effects on motor function, structural repair, cognition, mental well-being, and the immune system. Neurol Res Pract. 2023 May 11;5(1):18. doi: 10.1186/s42466-023-00244-w.

Reference Type: DERIVED

PMID: 37170385 (View on PubMed)

Other Identifiers

EXERTION

Identifier Type: -

Identifier Source: org_study_id