Acute StrokeSMS/TIANCT02902367
Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial
A study testing Outdoor walking and strength exercise in people with Acute Stroke and TIA (Transient Ischemic Attack), run by Uppsala County Council, Sweden at 1 site in Sweden.
Trial summary
Eighty community-living individuals in Uppsala municipality will be included. Intervention: Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments, questionnaires and medical records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, TIA (Transient Ischemic Attack)
- What is being tested?
- Outdoor walking and strength exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to Oct 2018
- 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
- Verified ischemic cerebral infarction or intracerebral hemorrhage.
- Sufficient walking capacity and motor function
- Able to communicate in Swedish
- Signed consent
Who cannot join
- One or more of the following:
- Subarachnoid bleeding
- Insufficient cognition and impaired ability to understand instructions
- Medical problems that make it unsuitable to participate
- Pacemaker (body composition measurements)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Birgit Vahlberg
Uppsala, 75185
Birgit Vahlberg, Med Dr, RPT, +18709583473, birgit.vahlberg@pubcare.uu.se
Tommy Cederholm, Professor, +18702733192, tommy.cederholm@pubcare.uu.se
About this study
Official title: Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial
Eighty community-living individuals in Uppsala municipality will be included. Intervention: Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments, questionnaires and medical records. Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity, mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be documented.
Read the detailed description
Eighty community-living individuals in Uppsala municipality will be included in a randomized controlled trial with two arms.
Intervention: Participants will perform an outdoor walking exercise program together with one strength exercise for 12 weeks. The intensity and frequency of the training will progressively increase. Participants are supposed to walk and perform strength training 5-7 days/week.
Methods: Clinical assessments, questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.
Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity (primary outcome measure), mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be evaluated.
Power analysis is performed. The investigators will analyze the data using an intention-to -treat analysis. Participants should have participated in at least 50% of the training sessions
- Conditions
- Acute Stroke, TIA (Transient Ischemic Attack)
- Being tested
- Outdoor walking and strength exercise, control group
- Keywords
- mobility, exercise, walking capacity, fat mass, muscles
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor walking and strength exerciseOther
Also called exercise
Exercise group: Participants are supposed to perform an outdoor walking exercise program and one strength exercise for 12 weeks. The first 2 weeks start with daily walks. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, i.e. chair-rising which also should be performed daily.
control groupOther
Also called control
Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: | Experimental | Outdoor walking and strength exercise, Three months, daily SMS. Receives: Other: Outdoor walking and strength exercise |
| Control group | Other | Usual care; no restriction for exercise, Three months Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test (6MWT)
walking capacity
Measured: from baseline walking capacity to three months
Secondary outcomes (11)
Short Physical Performance Battery (SPPB)
mobility
Measured: from baseline SPPB to three months
10 meter walk test (10mWT)
gait speed
Measured: from baseline 10mWT to three months
Hand-dynamometer (Jamar)
hand-grip strength
Measured: from baseline Jamar to three months
Body composition (bioelectric impedance analysis)
muscles and fat mass and BMI
Measured: from baseline body composition to three months
Cardiometabolic risk markers
blood lipids, c-reactive proteins (CRP), blood glukos, HbA1c, Insulin-like growth factor (IGF-1), Interleukin-6 (Il-6)
Measured: from baseline cardiometabolic risk markers to three months
Heart and lung foundation stress test
self-perceived stress
Measured: at baseline
Food frequency questionnaire
self-reported food intake and quality
Measured: at baseline
Montreal outcome assessment (MoCA)
cognition
Measured: at baseline
Modified rankin scale (MRS)
motor function
Measured: at baseline
Mortality
register-based mortality
Measured: from baseline to 1 year
Health-related quality of life
register-based quality of life
Measured: from baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala County Council, Sweden
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Birgit Vahlberg, Uppsala County Council, Sweden
- Investigators
- Birgit Vahlberg, Principal investigator, Sweden,Uppsala Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902367
- Sponsor's protocol ID
- UppsalaCC2
- Acronym
- SMS/TIA
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vahlberg BM, Eriksson S, Holmback U, Lundstrom E. Factors associated with changes in walking performance in individuals 3 months after stroke or TIA: secondary analyses from a randomised controlled trial of SMS-delivered training instructions in Sweden. BMJ Open. 2024 Mar 4;14(3):e078180. doi: 10.1136/bmjopen-2023-078180.
PubMed 38443081Vahlberg BM, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Potential effects on cardiometabolic risk factors and body composition by short message service (SMS)-guided training after recent minor stroke or transient ischaemic attack: post hoc analyses of the STROKEWALK randomised controlled trial. BMJ Open. 2021 Oct 18;11(10):e054851. doi: 10.1136/bmjopen-2021-054851.
PubMed 34663672Vahlberg B, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Effects on walking performance and lower body strength by short message service guided training after stroke or transient ischemic attack (The STROKEWALK Study): a randomized controlled trial. Clin Rehabil. 2021 Feb;35(2):276-287. doi: 10.1177/0269215520954346. Epub 2020 Sep 18.
PubMed 32942914
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02902367
- Acronym / sponsor ID
- SMS/TIA / UppsalaCC2
- Conditions
- Acute Stroke, TIA (Transient Ischemic Attack)
- Keywords
- mobility, exercise, walking capacity, fat mass, muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Uppsala County Council, SwedenOther government
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 15 Sep 2016 (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.
Eighty community-living individuals in Uppsala municipality will be included. Intervention: Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments, questionnaires and medical records. Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity, mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be documented.
Detailed description
Eighty community-living individuals in Uppsala municipality will be included in a randomized controlled trial with two arms.
Intervention: Participants will perform an outdoor walking exercise program together with one strength exercise for 12 weeks. The intensity and frequency of the training will progressively increase. Participants are supposed to walk and perform strength training 5-7 days/week.
Methods: Clinical assessments, questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.
Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity (primary outcome measure), mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be evaluated.
Power analysis is performed. The investigators will analyze the data using an intention-to -treat analysis. Participants should have participated in at least 50% of the training sessions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: | Experimental | Other: Outdoor walking and strength exerciseOutdoor walking and strength exercise, Three months, daily SMS. |
| Control group | Other | Other: control groupUsual care; no restriction for exercise, Three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Verified ischemic cerebral infarction or intracerebral hemorrhage.
- Sufficient walking capacity and motor function
- Able to communicate in Swedish
- Signed consent
Key exclusion criteria (5 listed)
- Subarachnoid bleeding
- Insufficient cognition and impaired ability to understand instructions
- Medical problems that make it unsuitable to participate
- Pacemaker (body composition measurements)
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 |
|---|---|---|
| Outdoor walking and strength exerciseAlso: exerciseExercise group: Participants are supposed to perform an outdoor walking exercise program and one strength exercise for 12 weeks. The first 2 weeks start with daily walks. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, i.e. chair-rising which also should be performed daily. | Other | Intervention: |
| control groupAlso: controlControl-Group: Treatment as usual for 12 weeks, without restriction of being physically active. | Other | Control group |
Primary outcome
6 minute walk test (6MWT)
Time frame: from baseline walking capacity to three months
walking capacity
11 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: from baseline SPPB to three months
10 meter walk test (10mWT)
Time frame: from baseline 10mWT to three months
Hand-dynamometer (Jamar)
Time frame: from baseline Jamar to three months
Body composition (bioelectric impedance analysis)
Time frame: from baseline body composition to three months
Cardiometabolic risk markers
Time frame: from baseline cardiometabolic risk markers to three months
Heart and lung foundation stress test
Time frame: at baseline
Food frequency questionnaire
Time frame: at baseline
Montreal outcome assessment (MoCA)
Time frame: at baseline
Modified rankin scale (MRS)
Time frame: at baseline
Mortality
Time frame: from baseline to 1 year
Health-related quality of life
Time frame: from baseline to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Derived from this study: PubMed 38443081Vahlberg BM, Eriksson S, Holmback U, Lundstrom E. Factors associated with changes in walking performance in individuals 3 months after stroke or TIA: secondary analyses from a randomised controlled trial of SMS-delivered training instructions in Sweden. BMJ Open. 2024 Mar 4;14(3):e078180. doi: 10.1136/bmjopen-2023-078180.
- Derived from this study: PubMed 34663672Vahlberg BM, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Potential effects on cardiometabolic risk factors and body composition by short message service (SMS)-guided training after recent minor stroke or transient ischaemic attack: post hoc analyses of the STROKEWALK randomised controlled trial. BMJ Open. 2021 Oct 18;11(10):e054851. doi: 10.1136/bmjopen-2021-054851.
- Derived from this study: PubMed 32942914Vahlberg B, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Effects on walking performance and lower body strength by short message service guided training after stroke or transient ischemic attack (The STROKEWALK Study): a randomized controlled trial. Clin Rehabil. 2021 Feb;35(2):276-287. doi: 10.1177/0269215520954346. Epub 2020 Sep 18.
- Individual participant dataSharing planned: Undecided
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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.
Birgit Vahlberg principal investigator
Sweden,Uppsala Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor walking and strength exercise in people with Acute Stroke and TIA (Transient Ischemic Attack), run by Uppsala 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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Vahlberg, Med Dr, RPT (+46709583473, birgit.vahlberg@pubcare.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (6MWT) (time frame: from baseline walking capacity to three 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 NCT02902367, which also lists 3 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 19 Sep 2017.