Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial

Conditions
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Acute Stroke, TIA (Transient Ischemic Attack)

Intervention / Treatment
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* Other: Outdoor walking and strength exercise
* Other: control group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention:<br>Outdoor walking and strength exercise, Three months, daily SMS. | Other: Outdoor walking and strength exercise<br>* 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.<br>* Other names: exercise;|
| Other: Control group<br>Usual care; no restriction for exercise, Three months | Other: control group<br>* Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test (6MWT) | walking capacity | from baseline walking capacity to three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) | mobility | from baseline SPPB to three months | 
| 10 meter walk test (10mWT) | gait speed | from baseline 10mWT to three months | 
| Hand-dynamometer (Jamar) | hand-grip strength | from baseline Jamar to three months | 
| Body composition (bioelectric impedance analysis) | muscles and fat mass and BMI | 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) | from baseline cardiometabolic risk markers to three months | 
| Heart and lung foundation stress test | self-perceived stress | at baseline | 
| Food frequency questionnaire | self-reported food intake and quality | at baseline | 
| Montreal outcome assessment (MoCA) | cognition | at baseline | 
| Modified rankin scale (MRS) | motor function | at baseline | 
| Mortality | register-based mortality | from baseline to 1 year | 
| Health-related quality of life | register-based quality of life | from baseline to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobility, exercise, walking capacity, fat mass, muscles