StrokeNCT01570920
Effects of Regular Brisk Walking in Chronic Stroke Patients
A study testing physical training in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2009to Mar 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke onset > or = 6 months
- Able to walk without human assistance (may use walking aid)
- Sign informed consent form
- Approval from physician for participation in study
- Live in Belgium or in Benin
Who cannot join
- cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure
- orthopedic, circulatory, or chronic pain conditions restricting exercise;
- dementia;
- severe receptive or global aphasia with inability to follow 2-step commands;
- co-morbid non-stroke neurological disorder that impairs mobility (e.g. MS or Parkinson's);
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Institut of Neuroscience (IoNS) / UCL, 5375
Brussels, Brussels Capital, 1200
About this study
Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking.
Read the detailed description
Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.
- Conditions
- Stroke
- Being tested
- physical training
- Keywords
- Activity limitations, restriction of participation, chronic stroke survival, physical activity, walking
- 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.
physical trainingBehavioural
walking many times a week
| Study group | Role | What they receive |
|---|---|---|
| walking | Experimental | a cohort of stroke patients trained during 3 month, based on walking Receives: Behavioral: physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACTIVLIM-Stroke (Activity limitations measures)
mainly self-reported outcomes measures
Measured: 7 months
Secondary outcomes (2)
Stroke Impairment
Stroke related impairment are assessed with specific outcomes measures (SIAS, BBS, ...).
Measured: 7 months
Walking ability
Walking ability is assessed throuht walking speed and walking endurance
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionMar 2011
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.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Thonnard, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570920
- Sponsor's protocol ID
- 2008/04JUIL/193
- Status last verified
- Apr 2012
- First submitted
- 30 Mar 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.
PubMed 23974944
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Brisk Walking in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT01570920
- Acronym / sponsor ID
- 2008/04JUIL/193
- Conditions
- Stroke
- Keywords
- Activity limitations, restriction of participation, chronic stroke survival, physical activity, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Apr 2012 (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.
Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking.
Detailed description
Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| walking | Experimental | Behavioral: physical traininga cohort of stroke patients trained during 3 month, based on walking |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke onset > or = 6 months
- Able to walk without human assistance (may use walking aid)
- Sign informed consent form
- Approval from physician for participation in study
- Live in Belgium or in Benin
Key exclusion criteria (5 listed)
- cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure
- orthopedic, circulatory, or chronic pain conditions restricting exercise;
- dementia;
- severe receptive or global aphasia with inability to follow 2-step commands;
- co-morbid non-stroke neurological disorder that impairs mobility (e.g. MS or Parkinson's);
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 |
|---|---|---|
| physical trainingwalking many times a week | Behavioural | walking |
Primary outcome
ACTIVLIM-Stroke (Activity limitations measures)
Time frame: 7 months
mainly self-reported outcomes measures
2 secondary outcomes
Stroke Impairment
Time frame: 7 months
Walking ability
Time frame: 7 months
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 Apr 2012.
- Derived from this study: PubMed 23974944Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.
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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.
Jean-Louis Thonnard, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical training in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 5 inclusion and 5 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 Apr 2012. 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 Belgium. 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?
ACTIVLIM-Stroke (Activity limitations measures) (time frame: 7 months). 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 NCT01570920, 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 4 Apr 2012.