Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial (SMS/TIA)
Primary Purpose
Acute Stroke, TIA (Transient Ischemic Attack)
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Outdoor walking and strength exercise
control group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring mobility, exercise, walking capacity, fat mass, muscles
Eligibility Criteria
Inclusion Criteria:
- Verified ischemic cerebral infarction or intracerebral hemorrhage.
- Sufficient walking capacity and motor function
- Able to communicate in Swedish
- Signed consent
Exclusion Criteria:
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)
Sites / Locations
- Birgit VahlbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention:
Control group
Arm Description
Outdoor walking and strength exercise, Three months, daily SMS.
Usual care; no restriction for exercise, Three months
Outcomes
Primary Outcome Measures
6 minute walk test (6MWT)
walking capacity
Secondary Outcome Measures
Short Physical Performance Battery (SPPB)
mobility
10 meter walk test (10mWT)
gait speed
Hand-dynamometer (Jamar)
hand-grip strength
Body composition (bioelectric impedance analysis)
muscles and fat mass and BMI
Cardiometabolic risk markers
blood lipids, c-reactive proteins (CRP), blood glukos, HbA1c, Insulin-like growth factor (IGF-1), Interleukin-6 (Il-6)
Heart and lung foundation stress test
self-perceived stress
Food frequency questionnaire
self-reported food intake and quality
Montreal outcome assessment (MoCA)
cognition
Modified rankin scale (MRS)
motor function
Mortality
register-based mortality
Health-related quality of life
register-based quality of life
Full Information
NCT ID
NCT02902367
First Posted
September 11, 2016
Last Updated
September 17, 2017
Sponsor
Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02902367
Brief Title
Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial
Acronym
SMS/TIA
Official Title
Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke, TIA (Transient Ischemic Attack)
Keywords
mobility, exercise, walking capacity, fat mass, muscles
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention:
Arm Type
Experimental
Arm Description
Outdoor walking and strength exercise, Three months, daily SMS.
Arm Title
Control group
Arm Type
Other
Arm Description
Usual care; no restriction for exercise, Three months
Intervention Type
Other
Intervention Name(s)
Outdoor walking and strength exercise
Other Intervention Name(s)
exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
control
Intervention Description
Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.
Primary Outcome Measure Information:
Title
6 minute walk test (6MWT)
Description
walking capacity
Time Frame
from baseline walking capacity to three months
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
mobility
Time Frame
from baseline SPPB to three months
Title
10 meter walk test (10mWT)
Description
gait speed
Time Frame
from baseline 10mWT to three months
Title
Hand-dynamometer (Jamar)
Description
hand-grip strength
Time Frame
from baseline Jamar to three months
Title
Body composition (bioelectric impedance analysis)
Description
muscles and fat mass and BMI
Time Frame
from baseline body composition to three months
Title
Cardiometabolic risk markers
Description
blood lipids, c-reactive proteins (CRP), blood glukos, HbA1c, Insulin-like growth factor (IGF-1), Interleukin-6 (Il-6)
Time Frame
from baseline cardiometabolic risk markers to three months
Title
Heart and lung foundation stress test
Description
self-perceived stress
Time Frame
at baseline
Title
Food frequency questionnaire
Description
self-reported food intake and quality
Time Frame
at baseline
Title
Montreal outcome assessment (MoCA)
Description
cognition
Time Frame
at baseline
Title
Modified rankin scale (MRS)
Description
motor function
Time Frame
at baseline
Title
Mortality
Description
register-based mortality
Time Frame
from baseline to 1 year
Title
Health-related quality of life
Description
register-based quality of life
Time Frame
from baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Verified ischemic cerebral infarction or intracerebral hemorrhage.
Sufficient walking capacity and motor function
Able to communicate in Swedish
Signed consent
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgit Vahlberg, Med Dr, RPT
Phone
+46709583473
Email
birgit.vahlberg@pubcare.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Tommy Cederholm, Professor,MD
Phone
+46702733192
Email
tommy.cederholm@pubcare.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Vahlberg
Organizational Affiliation
Sweden,Uppsala Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birgit Vahlberg
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgit Vahlberg, Med Dr, RPT
Phone
+18709583473
Email
birgit.vahlberg@pubcare.uu.se
First Name & Middle Initial & Last Name & Degree
Tommy Cederholm, Professor
Phone
+18702733192
Email
tommy.cederholm@pubcare.uu.se
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34663672
Citation
Vahlberg 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.
Results Reference
derived
PubMed Identifier
32942914
Citation
Vahlberg 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.
Results Reference
derived
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Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial
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