StrokeNCT07007507
Attendance and Adherence to Aerobic Exercise After Stroke
A study testing Aerobic Exercise in people with Stroke, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial summary
Stroke is a common cause of functional impairment and a disease that requires large financial resources and days of care(1). For a few years now, group or individual cardiorespiratory training has been a recommended part of subacute rehabilitation after stroke(2). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 13 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All stroke patients who can walk 5 meters and can sit on an ergometer cycle are invited.- Study participants must be able to read and understand the Swedish language in order to be able to assimilate study information.
Who cannot join
- Patients with medical or orthopedic conditions that prevent exercise should not participate in the study.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attendance and Adherence to Aerobic Exercise After Subacute Stroke: A Pilot Study
Stroke is a common cause of functional impairment and a disease that requires large financial resources and days of care(1). For a few years now, group or individual cardiorespiratory training has been a recommended part of subacute rehabilitation after stroke(2). The training form should be a routine part of stroke rehabilitation and should be able to be carried out in both hospitals, municipal facilities and at home(2). The benefits include better walking ability and improved quality of life(3). Despite the possible benefits of cardiorespiratory training, access to the training form has been limited and compliance with the recommendations has been low(4). The Rehab East Neuro Unit has decided to implement the training form in the spring of 2024 to increase access to the training form after stroke.
The purpose of this pilot study is to study attendance at training sessions and adherence with the training form's recommendations and guidelines over a six-month period.
By identifying any challenges that may arise during the study with recruitment, retention of participants or data collection, the pilot study will form the basis for a larger study that will involve multiple study sites. The pilot study will, through study protocols and interviews or surveys of patients and staff, shed light on study design, instruments for data collection and analysis methods. The results will be used to ensure that further studies are effective, appropriate and feasible. Compliance with guidelines will be evaluated with an exercise diary or digital registration.
Read the detailed description
Background During the last decades, various forms of exercise after stroke have been proposed(6). In 2000, cardiorespiratory exercise had a breakthrough when neurorehabilitation was introduced as a new field of research. Swedish research showed that neurons are capable of neurogenesis and plasticity(7,8). Experimental studies showed that exercise could be an important catalyst in this process.(9) Interest in fitness training after stroke was soon reflected in major reviews with a rapidly increasing number of published articles (10). Exercise is described as a range of physical activity that is planned, structured, and repetitive and has improvement or maintenance of physical fitness as an intermediate or ultimate goal.(11) Aerobic exercise refers to the use of oxygen in the combustion to adequately meet the energy demand during exercise via aerobic metabolism.(12) Aerobic exercise is performed by repeating sequences of activities with light to moderate intensity for extended periods of time.(12) The American Heart Association recommends for stroke survivors that exercise intensity should be 40%-70% of Vo2 reserve or heart rate (HR) reserve; 55%-80% HR max; RPE 11-14 Borg rating of perceived exertion (RPE) scale 6-20 scale, 3-5 days/week, 30-60 min/session (or several 10-minute sessions)(13) Studies have shown that cardiorespiratory exercise can affect recovery after stroke. The mechanisms behind the improvement have not been fully elucidated, but the form of exercise can be expected to affect healing after the injury. Cardiorespiratory exercise in groups or individually has been a recommended part of subacute rehabilitation after stroke for a few years(2). Despite the possible benefits of cardiorespiratory exercise, access to the form of exercise has been limited and compliance with the recommendations has been low(4). Identification of barriers to the form of exercise is of great importance in order to be able to offer optimal recovery opportunities for the disease group. There is currently a lack of studies on how many patients participate in the form of exercise or how many patients reach the recommendations.
Purpose - question Primary purpose: The purpose of the pilot study is to study and evaluate participation and adherence to group-based fitness training in the subacute phase after stroke. The work also aims to study and test methods for studying the patient's experiences with the training and factors that affect the implementation of the training in everyday clinical practice
The purpose of the pilot study is to study attendance at training sessions and adherence to the training format's recommendations and guidelines over a period of six months.
- To investigate how many patients are willing to participate in fitness-based group training after stroke.
- To investigate how many of these patients reach the recommended amount and intensity of training.
- To investigate the patient's experiences with the training format
Method The pilot study is conducted as a prospective cohort study at Vrinnevis Hospital's stroke unit. Patients are invited consecutively after becoming ill and completing inpatient care. The invitation to training is made by the responsible physiotherapist in consultation with the responsible physician. Training starts after discharge and no earlier than 7 days after illness and up to and including 6 months after illness. Training sessions and training program are designed so that current guidelines can be achieved. Two training sessions are offered at Vrinnvis Hospital under the guidance of a physiotherapist. Additional training sessions are carried out at home according to an individually designed program by a physiotherapist. Descriptive statistics are used to describe individual variables and attendance.
All stroke patients who are able to walk 5 meters and can sit on an ergometer cycle are invited. NIHSS 6
Patients with medical or orthopedic problems that prevent the implementation of training should not participate in the study.
Study participants must be able to read and understand the Swedish language in order to be able to assimilate study information
The study will be carried out close to the usual clinical routine after stroke and only a few outcome variables and study-specific forms will be added.Study start: September 2024 and the pilot study is expected to last until April 2025.
After the training period, training diaries and registered training sessions will be documented in a study-specific database and analyzed for attendance and compliance. To achieve 100% compliance with the guidelines, the patient must complete a total of 3 training sessions of 30-60 minutes per week for 12 weeks. Interviews or surveys of the patients' experience of the training will be conducted after the training has been completed after week 12.
- Conditions
- Stroke
- Being tested
- Aerobic Exercise
- Keywords
- Stroke, Aerobic exercise, Attendence, Adherence
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Aerobic exercise is performed by repeating sequences of light to moderate intensity activities for extended periods of time.(12) The American Heart Association recommends that for stroke survivors, exercise intensity should be 40%-70% of VO2 reserve or heart rate (HR) reserve; 55%-80% HR max; RPE 11-14 Borg rating of perceived exertion (RPE) scale 6-20 scale, 3-5 days/week, 30-60 min/session (or multiple 10 min sessions)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Two organized training sessions per week and one personal fitness activity once a week Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendence
Participation in number of organized training sessions and own physical activities
Measured: From enrollment to the end of treatment after 8 weeks
Secondary outcomes (1)
Adherence
To achieve 100% adherence with the guidelines, the patient must complete a total of 3 training sessions of 30-60 minutes per week for 8 weeks. Interviews or surveys of the patients' experience of the training will be conducted after the training has been completed after week 8.
Measured: From enrollment to the end of treatment after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start13 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klas Sandberg, Ostergotland County Council, Sweden
- Investigators
- Klas Sandberg, PhD, Principal investigator, Ostergotland CCKlas Sandberg, PhD, Study director, Ostergotland CC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007507
- Sponsor's protocol ID
- 2024-04914-01
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilotstudy with focus on feasability. Further, in a large full scale study maybe IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attendance and Adherence to Aerobic Exercise After Subacute Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT07007507
- Acronym / sponsor ID
- 2024-04914-01
- Conditions
- Stroke
- Keywords
- Stroke, Aerobic exercise, Attendence, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is a common cause of functional impairment and a disease that requires large financial resources and days of care(1). For a few years now, group or individual cardiorespiratory training has been a recommended part of subacute rehabilitation after stroke(2). The training form should be a routine part of stroke rehabilitation and should be able to be carried out in both hospitals, municipal facilities and at home(2). The benefits include better walking ability and improved quality of life(3). Despite the possible benefits of cardiorespiratory training, access to the training form has been limited and compliance with the recommendations has been low(4). The Rehab East Neuro Unit has decided to implement the training form in the spring of 2024 to increase access to the training form after stroke.
The purpose of this pilot study is to study attendance at training sessions and adherence with the training form's recommendations and guidelines over a six-month period.
By identifying any challenges that may arise during the study with recruitment, retention of participants or data collection, the pilot study will form the basis for a larger study that will involve multiple study sites. The pilot study will, through study protocols and interviews or surveys of patients and staff, shed light on study design, instruments for data collection and analysis methods. The results will be used to ensure that further studies are effective, appropriate and feasible. Compliance with guidelines will be evaluated with an exercise diary or digital registration.
Detailed description
Background During the last decades, various forms of exercise after stroke have been proposed(6). In 2000, cardiorespiratory exercise had a breakthrough when neurorehabilitation was introduced as a new field of research. Swedish research showed that neurons are capable of neurogenesis and plasticity(7,8). Experimental studies showed that exercise could be an important catalyst in this process.(9) Interest in fitness training after stroke was soon reflected in major reviews with a rapidly increasing number of published articles (10). Exercise is described as a range of physical activity that is planned, structured, and repetitive and has improvement or maintenance of physical fitness as an intermediate or ultimate goal.(11) Aerobic exercise refers to the use of oxygen in the combustion to adequately meet the energy demand during exercise via aerobic metabolism.(12) Aerobic exercise is performed by repeating sequences of activities with light to moderate intensity for extended periods of time.(12) The American Heart Association recommends for stroke survivors that exercise intensity should be 40%-70% of Vo2 reserve or heart rate (HR) reserve; 55%-80% HR max; RPE 11-14 Borg rating of perceived exertion (RPE) scale 6-20 scale, 3-5 days/week, 30-60 min/session (or several 10-minute sessions)(13) Studies have shown that cardiorespiratory exercise can affect recovery after stroke. The mechanisms behind the improvement have not been fully elucidated, but the form of exercise can be expected to affect healing after the injury. Cardiorespiratory exercise in groups or individually has been a recommended part of subacute rehabilitation after stroke for a few years(2). Despite the possible benefits of cardiorespiratory exercise, access to the form of exercise has been limited and compliance with the recommendations has been low(4). Identification of barriers to the form of exercise is of great importance in order to be able to offer optimal recovery opportunities for the disease group. There is currently a lack of studies on how many patients participate in the form of exercise or how many patients reach the recommendations.
Purpose - question Primary purpose: The purpose of the pilot study is to study and evaluate participation and adherence to group-based fitness training in the subacute phase after stroke. The work also aims to study and test methods for studying the patient's experiences with the training and factors that affect the implementation of the training in everyday clinical practice
The purpose of the pilot study is to study attendance at training sessions and adherence to the training format's recommendations and guidelines over a period of six months.
- To investigate how many patients are willing to participate in fitness-based group training after stroke.
- To investigate how many of these patients reach the recommended amount and intensity of training.
- To investigate the patient's experiences with the training format
Method The pilot study is conducted as a prospective cohort study at Vrinnevis Hospital's stroke unit. Patients are invited consecutively after becoming ill and completing inpatient care. The invitation to training is made by the responsible physiotherapist in consultation with the responsible physician. Training starts after discharge and no earlier than 7 days after illness and up to and including 6 months after illness. Training sessions and training program are designed so that current guidelines can be achieved. Two training sessions are offered at Vrinnvis Hospital under the guidance of a physiotherapist. Additional training sessions are carried out at home according to an individually designed program by a physiotherapist. Descriptive statistics are used to describe individual variables and attendance.
All stroke patients who are able to walk 5 meters and can sit on an ergometer cycle are invited. NIHSS 6
Patients with medical or orthopedic problems that prevent the implementation of training should not participate in the study.
Study participants must be able to read and understand the Swedish language in order to be able to assimilate study information
The study will be carried out close to the usual clinical routine after stroke and only a few outcome variables and study-specific forms will be added.Study start: September 2024 and the pilot study is expected to last until April 2025.
After the training period, training diaries and registered training sessions will be documented in a study-specific database and analyzed for attendance and compliance. To achieve 100% compliance with the guidelines, the patient must complete a total of 3 training sessions of 30-60 minutes per week for 12 weeks. Interviews or surveys of the patients' experience of the training will be conducted after the training has been completed after week 12.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseTwo organized training sessions per week and one personal fitness activity once a week |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All stroke patients who can walk 5 meters and can sit on an ergometer cycle are invited.- Study participants must be able to read and understand the Swedish language in order to be able to assimilate study information.
Key exclusion criteria (1 listed)
- Patients with medical or orthopedic conditions that prevent exercise should not participate in the study.-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAerobic exercise is performed by repeating sequences of light to moderate intensity activities for extended periods of time.(12) The American Heart Association recommends that for stroke survivors, exercise intensity should be 40%-70% of VO2 reserve or heart rate (HR) reserve; 55%-80% HR max; RPE 11-14 Borg rating of perceived exertion (RPE) scale 6-20 scale, 3-5 days/week, 30-60 min/session (or multiple 10 min sessions) | Behavioural | Aerobic Exercise |
Primary outcome
Attendence
Time frame: From enrollment to the end of treatment after 8 weeks
Participation in number of organized training sessions and own physical activities
1 secondary outcome
Adherence
Time frame: From enrollment to the end of treatment after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Undecided. This is a pilotstudy with focus on feasability. Further, in a large full scale study maybe IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klas Sandberg, PhD principal investigator
Ostergotland CC
Klas Sandberg, PhD study director
Ostergotland CC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Stroke, run by Ostergotland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendence (time frame: From enrollment to the end of treatment after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.