Effects of Aerobic Exercise During the Early Rehabilitation After Ischemic Stroke

NCT05690165 | Completed

• 1 other identifier: EXERTION
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Stroke Rehabilitation

Keywords

Motor Function; Aerobic Exercise; Immune System; Cognition

Outcome Measures

Primary Outcomes (1)

• Motor function

  Recovery of motor function is assessed by fugl-meyer assessment (FMA). The FMA-UE (upper extremity) is measured in a score with a maximum of 66 points for motor function, the FMA-LE (lower extremity) extends up to a sum score of 34 points for motor function.

  90 days

Secondary Outcomes (5)

• Cognition

  90 days

• Fatigue

  90 days

• Physical Comfort

  90 days

• Flow cytometry analysis of cryoasservated peripheral blood mononuclear cells (PBMC)

  90 days

• Structural axonal changes

  90 days

Study Arms (2)

Exercise Group

EXPERIMENTAL

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.

Behavioral: Walking Exercise

No Exercise Group

NO INTERVENTION

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

Interventions

Walking Exercise BEHAVIORAL

Heart rate controlled walking exercise

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Münster

Münster, Northrine-Westphalia, D-48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 37170385 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antje Schmidt-Pogoda, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 19, 2023
• Study Start: October 26, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)