- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02720276
Sms Guided Training After Acute Stroke (StrokeWalk)
Sms Guided Training After Acute Stroke: A Pilot Study
The purpose of this exploratory study is to investigate how a predetermined outdoor walking program (12 weeks) is best delivered to individuals with stroke over 18 years, either by smartphone and the Short Message Service (SMS) or video link.
Furthermore, the aim is to investigate how the study design works in practice and determine the effects of the outdoor walking exercise program in combination with a leg exercise on physical functioning (walking capacity, gait speed, mobility and grip strength).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Twenty community-living individuals in Uppsala municipality will be included and treated with a cross-over design. Ten individuals will initially receive exercise instructions to their smartphones via Short Message Service (SMS) for 6 weeks and after that instructions by a video link (6 weeks). Another 10 individuals will initially receive instructions by a video link and then switching to management with SMS after 6 weeks of training.
Intervention: Participants are supposed to perform an outdoor walking exercise program for 12 weeks. The walks should gradually increase in frequency and intensity, and is expected to start after discharge from the stroke department, after the assessment. The first 2 weeks start with daily walks. The walks will be conducted at a pace that increases the heart rate but still makes it possible to talk. 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, which should be performed in connection with the walk training.
Methods: 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 are only performed as screening at baseline measurements. Objective evaluation of the participants' adherence to the outdoor walking program will be measured with a training diary where the individual documents whether they have followed the training instructions.
Power analysis is not performed since this is an exploratory study. The investigators will analyze the data using an intention-to -treat. The investigators will also do a 'per-protocol analysis, where only participants who completed the training are included. Participants should have participated in at least 50% of the training sessions. All analyzes will be done using SPSS version 23 (IBM, Armonk).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 18 years
- Verified ischemic cerebral infarction or intracerebral hemorrhage.
- Sufficient walking capacity and motor function
- Able to communicate in Swedish
- Signed consent
Exclusion Criteria:
Are one or more of the following:
- Subarachnoid bleeding
- Insufficient cognition and impaired ability to understand instructions
- Medical problems that make it unsuitable to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training after acute stroke
Intervention: Outdoor walking and strength training.
|
Outdoor walking: Participants will receive daily training instructions via Short message Service (SMS) over 12 weeks.
The walks are increased in frequency and intensity.
The intensity are rated using the Borg scale to 12-15.
The first 2 weeks begins with daily walks of 10 minutes.
The last 4 weeks the walk training will partly be performed in intervals in combination with conventional outdoor walks.
The interval training includes warming-up (5 minutes), fast walking for 4 minutes alternated with slower walking for three minutes.
This is repeated 3 times, followed by cooling down for about five minutes.
Strength training: to repeatedly get up from sitting.
Number of repetitions will increase from 5-20 per set and will be performed daily in 3 sets with a short rest between each set.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Minutes Walk Test
Time Frame: change from baseline walking capacity to three months
|
walking capacity
|
change from baseline walking capacity to three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Physical Performance Battery
Time Frame: change from baseline mobility to three months
|
mobility
|
change from baseline mobility to three months
|
10 meters walk test
Time Frame: change from baseline gait speed to three months
|
gait speed
|
change from baseline gait speed to three months
|
Montreal Outcome Assessment
Time Frame: baseline
|
cognitive function
|
baseline
|
Modified Rankin Scale
Time Frame: baseline
|
motor function
|
baseline
|
Saltin Grimby Physical Activity Level Scale
Time Frame: baseline
|
level of physical activity
|
baseline
|
Jamar hand dynamometer
Time Frame: change from baseline hand-grip strength to three months
|
hand-grip strength
|
change from baseline hand-grip strength to three months
|
The Visual Analogue Rating Scale (VAS)
Time Frame: change from six baseline to three months.
|
Report of how to deliver the best instructions.
|
change from six baseline to three months.
|
The Visual Analogue Rating Scale (VAS)
Time Frame: change from baseline to three months.
|
Report of how to deliver the best instructions.
|
change from baseline to three months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Birgit Vahlberg, Med Dr, RPT, VO Paramedicin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UppsalaCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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