StrokeNCT02107768

Aerobic Exercise in Early Subacute Stroke

A study testing Aerobic exercise in people with Stroke, run by Klas Sandberg.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Stroke
What is being tested?: Aerobic exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: No sites listed yet
Study dates: Jan 2011to Sep 2013
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to understand Swedish language.
Ability to walk 5 meters with or without the support of any means or person.
Be able to get up on a cycle ergometer and cycle in their own chosen pace.
Approval of medically responsible physician to conduct physical training in groups.

Who cannot join

Medical or neurological diseases that may affect the exercise execution.
Patients for whom transportation to and from hospital can not be arranged during intervention period

About this study

Official title: Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.

The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.

Conditions: Stroke
Being tested: Aerobic exercise
Keywords: Stroke, Exercise, Randomized trial, Quality of Life
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.

Aerobic exerciseOther
Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) .
Two fitness goals was to be achieved during the training session
1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate.
2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate.

Study groups in NCT02107768
Study group	Role	What they receive
Exercise recommendation	Experimental	Patients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts Receives: Other: Aerobic exercise
Aerobic exercise	Experimental	The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added. The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20, Rate of Perceived Exertion (Borg 's RPE scale) Two fitness goals was to be achieved during the training session: 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) .Which corresponds to 85% of maximum heart rate. Receives: Other: Aerobic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Aerobic capacity
cardiorespiratory stress test (Watt)
Measured: Baseline,3month

Secondary outcomes (2)

Balance
Time Up and Go(TUG) ,Single Leg Stance(SLS)
Measured: Baseline,3month
Walking capacity
Six minute walk test (6MWT ), 10 meters Walking test
Measured: Baseline,3month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Sep 2013

First posted8 Apr 2014 (estimated)
Study startJan 2011
Primary completionJun 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02107768
Sponsor's protocol ID: 2010/396-31
Status last verified: Feb 2015
First submitted: 3 Apr 2014
Last updated: 4 Feb 2015
Results posted: No
Data monitoring committee: No

Publications

Wijkman MO, Sandberg K, Kleist M, Falk L, Enthoven P. The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise. J Clin Hypertens (Greenwich). 2018 Jan;20(1):56-64. doi: 10.1111/jch.13157. Epub 2018 Jan 16.
PubMed 29338111
Sandberg K, Kleist M, Falk L, Enthoven P. Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1244-53. doi: 10.1016/j.apmr.2016.01.030. Epub 2016 Feb 20.
PubMed 26903147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
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CoMind Early Feasibility Study
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT02107768
Acronym / sponsor ID: 2010/396-31
Conditions: Stroke
Keywords: Stroke, Exercise, Randomized trial, Quality of Life
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Klas SandbergUniversity, hospital or other
Study start: Jan 2011
Primary completion: Jun 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 8 Apr 2014 (estimated)
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.

The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Exercise recommendation	Experimental	Other: Aerobic exercisePatients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts
Aerobic exercise	Experimental	Other: Aerobic exerciseThe intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added. The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20, Rate of Perceived Exertion (Borg 's RPE scale) Two fitness goals was to be achieved during the training session: 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) .Which corresponds to 85% of maximum heart rate.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ability to understand Swedish language.
Ability to walk 5 meters with or without the support of any means or person.
Be able to get up on a cycle ergometer and cycle in their own chosen pace.
Approval of medically responsible physician to conduct physical training in groups.

Key exclusion criteria (2 listed)

Medical or neurological diseases that may affect the exercise execution.
Patients for whom transportation to and from hospital can not be arranged during intervention period

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 exerciseOther: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) . Two fitness goals was to be achieved during the training session 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate.	Other	Aerobic exercise, Exercise recommendation

Primary outcome

Aerobic capacity
Time frame: Baseline,3month
cardiorespiratory stress test (Watt)

2 secondary outcomes

Balance
Time frame: Baseline,3month
Walking capacity
Time frame: Baseline,3month

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 4 Feb 2015.
Derived from this study: PubMed 29338111Wijkman MO, Sandberg K, Kleist M, Falk L, Enthoven P. The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise. J Clin Hypertens (Greenwich). 2018 Jan;20(1):56-64. doi: 10.1111/jch.13157. Epub 2018 Jan 16.
Derived from this study: PubMed 26903147Sandberg K, Kleist M, Falk L, Enthoven P. Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1244-53. doi: 10.1016/j.apmr.2016.01.030. Epub 2016 Feb 20.

Related trials for Stroke

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

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, Msc,RPT principal investigator

Rehab East, Local Health Care Östergötland County Council

Marie Kleist, Bsc,RPT principal investigator

Rehab East, Local Health Care Östergötland County Council

Lars Falk, PhD,MD principal investigator

Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic 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 2 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 4 Feb 2015. 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?

Aerobic capacity (time frame: Baseline,3month). 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 NCT02107768, which also lists 2 linked publications.

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 4 Feb 2015.