StrokeNCT04241952
Effects of Early Exercise in Patients With Moderate to Severe Stroke.
A study testing Exercise in people with Stroke, run by Klas Sandberg.
Trial summary
Purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability. Methods: Patients with medium to severe stroke (NHISS >7) were recruited 24 - 48 hours after stroke onset from two stroke units in Sweden. Both groups received usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2015to 30 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Diagnose stroke with The National Institutes of Health Stroke Scale (NIHSS) 7-42 points.
- Ability to understand the Swedish language.
- Approval of medical responsible physician to participate in the study.
Who cannot join
- Medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.
About this study
Official title: Effects of Early Exercise in Patients With Moderate to Severe Stroke - a Randomized Controlled Trial
Purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability.
Methods: Patients with medium to severe stroke (NHISS >7) were recruited 24 - 48 hours after stroke onset from two stroke units in Sweden. Both groups received usual care. The intervention group received even 20 minutes bed-cycling 5 days per week with a maximum of 15 sessions. Functional outcome was measured with modified Rankin Scale (mRS) and Barthel index and walking with the 6-minute walking test (6MWT). Measurements were performed pre- and post-intervention (3 weeks), and at 3-months follow-up.
- Conditions
- Stroke
- Being tested
- Exercise
- Keywords
- Stroke, Rehabilitation, Exercise, Bedcycling
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Bedcycling
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Usual care and bedcycling. Receives: Other: Exercise |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Rankin Scale (mRS)
Functional Outcome
Measured: Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.
Secondary outcomes (2)
Change in Barthel ADL-Index
ADL
Measured: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Change in 6-Minutes Walking test (6MWT)
Walking Ability
Measured: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Dec 2015
- Primary completion15 Dec 2015
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klas Sandberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klas Sandberg, Ostergotland County Council, Sweden
- Investigators
- Paul Enthoven, PhD, Principal investigator, Linkopings University,Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241952
- Sponsor's protocol ID
- Stroke2015
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sandberg K, Kleist M, Enthoven P, Wijkman M. Hemodynamic responses to In-Bed Cycle Exercise in the acute phase after moderate to severe stroke: A randomized controlled trial. J Clin Hypertens (Greenwich). 2021 May;23(5):1077-1084. doi: 10.1111/jch.14232. Epub 2021 Mar 11.
PubMed 33704913
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Exercise in Patients With Moderate to Severe Stroke - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04241952
- Acronym / sponsor ID
- Stroke2015
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Exercise, Bedcycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Klas SandbergUniversity, hospital or other
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Jan 2020 (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.
Purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability.
Methods: Patients with medium to severe stroke (NHISS >7) were recruited 24 - 48 hours after stroke onset from two stroke units in Sweden. Both groups received usual care. The intervention group received even 20 minutes bed-cycling 5 days per week with a maximum of 15 sessions. Functional outcome was measured with modified Rankin Scale (mRS) and Barthel index and walking with the 6-minute walking test (6MWT). Measurements were performed pre- and post-intervention (3 weeks), and at 3-months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: ExerciseUsual care and bedcycling. |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years.
- Diagnose stroke with The National Institutes of Health Stroke Scale (NIHSS) 7-42 points.
- Ability to understand the Swedish language.
- Approval of medical responsible physician to participate in the study.
Key exclusion criteria (1 listed)
- Medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.
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 |
|---|---|---|
| ExerciseBedcycling | Other | Exercise group |
Primary outcome
Change in Modified Rankin Scale (mRS)
Time frame: Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.
Functional Outcome
2 secondary outcomes
Change in Barthel ADL-Index
Time frame: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Change in 6-Minutes Walking test (6MWT)
Time frame: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
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 27 Jan 2020.
- Derived from this study: PubMed 33704913Sandberg K, Kleist M, Enthoven P, Wijkman M. Hemodynamic responses to In-Bed Cycle Exercise in the acute phase after moderate to severe stroke: A randomized controlled trial. J Clin Hypertens (Greenwich). 2021 May;23(5):1077-1084. doi: 10.1111/jch.14232. Epub 2021 Mar 11.
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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.
Paul Enthoven, PhD principal investigator
Linkopings University,Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Stroke, run by Klas Sandberg.
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 4 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Modified Rankin Scale (mRS) (time frame: Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241952, which also lists 1 linked publication.
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 27 Jan 2020.