Sms Guided Training After Acute Stroke (StrokeWalk)
Primary Purpose
Acute Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training after acute stroke
Sponsored by

About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring stroke, exercise, walking, mobility
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training after acute stroke
Arm Description
Intervention: Outdoor walking and strength training.
Outcomes
Primary Outcome Measures
6 Minutes Walk Test
walking capacity
Secondary Outcome Measures
Short Physical Performance Battery
mobility
10 meters walk test
gait speed
Montreal Outcome Assessment
cognitive function
Modified Rankin Scale
motor function
Saltin Grimby Physical Activity Level Scale
level of physical activity
Jamar hand dynamometer
hand-grip strength
The Visual Analogue Rating Scale (VAS)
Report of how to deliver the best instructions.
The Visual Analogue Rating Scale (VAS)
Report of how to deliver the best instructions.
Full Information
NCT ID
NCT02720276
First Posted
March 16, 2016
Last Updated
September 17, 2017
Sponsor
Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02720276
Brief Title
Sms Guided Training After Acute Stroke
Acronym
StrokeWalk
Official Title
Sms Guided Training After Acute Stroke: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala County Council, Sweden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
stroke, exercise, walking, mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training after acute stroke
Arm Type
Experimental
Arm Description
Intervention: Outdoor walking and strength training.
Intervention Type
Other
Intervention Name(s)
Training after acute stroke
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 Minutes Walk Test
Description
walking capacity
Time Frame
change from baseline walking capacity to three months
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
mobility
Time Frame
change from baseline mobility to three months
Title
10 meters walk test
Description
gait speed
Time Frame
change from baseline gait speed to three months
Title
Montreal Outcome Assessment
Description
cognitive function
Time Frame
baseline
Title
Modified Rankin Scale
Description
motor function
Time Frame
baseline
Title
Saltin Grimby Physical Activity Level Scale
Description
level of physical activity
Time Frame
baseline
Title
Jamar hand dynamometer
Description
hand-grip strength
Time Frame
change from baseline hand-grip strength to three months
Title
The Visual Analogue Rating Scale (VAS)
Description
Report of how to deliver the best instructions.
Time Frame
change from six baseline to three months.
Title
The Visual Analogue Rating Scale (VAS)
Description
Report of how to deliver the best instructions.
Time Frame
change from baseline to three months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Vahlberg, Med Dr, RPT
Organizational Affiliation
VO Paramedicin
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sms Guided Training After Acute Stroke
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