Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial (SMS/TIA)
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|ClinicalTrials.gov Identifier: NCT02902367|
Recruitment Status : Unknown
Verified September 2017 by Birgit Vahlberg, Uppsala County Council, Sweden.
Recruitment status was: Recruiting
First Posted : September 15, 2016
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke TIA (Transient Ischemic Attack)||Other: Outdoor walking and strength exercise Other: control group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||October 2018|
Outdoor walking and strength exercise, Three months, daily SMS.
Other: Outdoor walking and strength 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.
Other Name: exercise
Usual care; no restriction for exercise, Three months
Other: control group
Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.
Other Name: control
- 6 minute walk test (6MWT) [ Time Frame: from baseline walking capacity to three months ]walking capacity
- Short Physical Performance Battery (SPPB) [ Time Frame: from baseline SPPB to three months ]mobility
- 10 meter walk test (10mWT) [ Time Frame: from baseline 10mWT to three months ]gait speed
- Hand-dynamometer (Jamar) [ Time Frame: from baseline Jamar to three months ]hand-grip strength
- Body composition (bioelectric impedance analysis) [ Time Frame: from baseline body composition to three months ]muscles and fat mass and BMI
- Cardiometabolic risk markers [ Time Frame: from baseline cardiometabolic risk markers to three months ]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 [ Time Frame: at baseline ]self-perceived stress
- Food frequency questionnaire [ Time Frame: at baseline ]self-reported food intake and quality
- Montreal outcome assessment (MoCA) [ Time Frame: at baseline ]cognition
- Modified rankin scale (MRS) [ Time Frame: at baseline ]motor function
- Mortality [ Time Frame: from baseline to 1 year ]register-based mortality
- Health-related quality of life [ Time Frame: from baseline to 1 year ]register-based quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902367
|Contact: Birgit Vahlberg, Med Dr, RPTfirstname.lastname@example.org|
|Contact: Tommy Cederholm, Professor,MDemail@example.com|
|Uppsala, Sweden, 75185|
|Contact: Birgit Vahlberg, Med Dr, RPT +18709583473 firstname.lastname@example.org|
|Contact: Tommy Cederholm, Professor +18702733192 email@example.com|
|Principal Investigator:||Birgit Vahlberg||Sweden,Uppsala Uppsala University Hospital|