Aerobic Exercise Training in Acute Ischaemic Stroke
ATAS
1 other identifier
interventional
30
1 country
1
Brief Summary
Stroke is a leading cause of adult disability in the UK. There are few treatment options that improve long-term disability outcomes after stroke. Animal studies indicate that aerobic exercise training can improve brain repair and reduce disability after stroke. However, in clinical practice it is difficult for stroke survivors to undertake aerobic exercise due to lower-limb disability and a lack of accessible exercise equipment. This study will assess the feasibility of implementing a 5-day aerobic exercise training intervention, beginning in the acute phase of stroke (1-7 days post-stroke), using a power-assisted exercise bike. Feasibility outcome measures: recruitment rate (30 participants recruited within 18 months), completeness of data (\>80% of planned measurements recorded) and the safety (\<10 adverse events related to the intervention) and acceptability (\>3/5 comfort scale) of the intervention. We will also investigate the acute effects of aerobic exercise on cerebral blood flow velocity using transcranial Doppler ultrasound, and brain-derived neurotrophic factor (serum and plasma).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
1 active site
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
First Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedStudy Start
First participant enrolled
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2022
CompletedAugust 21, 2023
August 1, 2023
1.3 years
January 19, 2021
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety of aerobic exercise training
The following traffic light-style system is proposed: * Red: \>10 adverse events related to the intervention - do not proceed. * Amber: 5-10 adverse events related to the intervention - review and revise protocol. * Green: \<5 adverse events related to the intervention - proceed.
21 months
Acceptability of aerobic exercise training
Average comfort score \> 3/5 Likert scale (1= very uncomfortable to 5= very comfortable)
18 months
Secondary Outcomes (2)
Feasibility of recruitment
18 months
Feasibility of data collection
21 months
Other Outcomes (19)
Rectus femoris cross sectional area
Baseline, 1 week and 3 months
Rectus femoris muscle thickness
Baseline, 1 week and 3 months
Vastus lateralis muscle thickness
Baseline, 1 week and 3 months
- +16 more other outcomes
Study Arms (2)
Usual care
NO INTERVENTIONIntervention
EXPERIMENTALInterventions
5-day, power-assisted, low- to moderate-intensity, aerobic exercise training programme. Exercise duration to progress from 10 minutes on day 1, to 30 minutes on day 5. Exercise equipment: Letto-2 (Motomed, Germany).
Eligibility Criteria
You may qualify if:
- Adult (age \>18 years) patients diagnosed with acute ischaemic stroke 1-7 days previously.
- Medically stable, assessed by a stroke physician.
- Sufficient English language comprehension and cognitive ability to understand the study protocol, follow instructions, complete questionnaires and give informed consent.
- Ability to mobilise lower body limbs in a cyclical manner (at least one leg).
- Likely to be admitted to the Royal Hallamshire Hospital for at least 7 days.
You may not qualify if:
- Haemorrhagic stroke.
- \<1 day or \>7 days after onset of stroke symptoms.
- Clinically unstable, assessed by stroke physician.
- Disability preventing unipedal cycling.
- New York Heart Failure Classification stage III/IV.
- Terminal illness (life expectancy \<6 months).
- Resting blood pressure \>180/110 mmHg.
- Uncontrolled arrhythmia causing symptoms or haemodynamic compromise.
- Unstable angina.
- Uncontrolled diabetes mellitus.
- Acute deep vein thrombosis, pulmonary embolism or pulmonary infection.
- Already participating in a clinical research trial.
- Pain during mobilisation of lower-limbs.
- Lower-limb spasticity or contracture which impairs ability to cycle.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Maden-Wilkinson, PhD
Sheffield Hallam University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Fellow
Study Record Dates
First Submitted
January 19, 2021
First Posted
February 8, 2021
Study Start
April 27, 2021
Primary Completion
August 25, 2022
Study Completion
August 25, 2022
Last Updated
August 21, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Study protocol publication: \<12 months of trial initiation. Clinical study report: \<24 months after trial end date.
- Access Criteria
- Data sharing enquires may be sent to Dr Simon Nichols, s.j.nichols@shu.ac.uk.
We will have exclusive access to the data for 24 months after the end date of the study whilst we develop a protocol and grant application, and publish our findings. Data will be accessible before 24 months should these objectives be achieved earlier than expected. Anonymised data will be provided on application rather than be offered open access. A description of the data will be placed on the University open access repository (SHURDA). Data sharing will be subject to an application. No sensitive/personal data will be made available. All external users of our data will be bound by a data sharing agreement between the research team, the University, and the user themselves. Data will be supplied on the condition that their research is non-profit, and that their findings will be published in an open access domain. Data users will not be permitted to share the data with anyone outside of their immediate research team.