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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
Uppsala County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring stroke, exercise, walking, mobility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ≥ 18 years
  2. Verified ischemic cerebral infarction or intracerebral hemorrhage.
  3. Sufficient walking capacity and motor function
  4. Able to communicate in Swedish
  5. Signed consent

Exclusion Criteria:

Are one or more of the following:

  1. Subarachnoid bleeding
  2. Insufficient cognition and impaired ability to understand instructions
  3. 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

    First Posted
    March 16, 2016
    Last Updated
    September 17, 2017
    Sponsor
    Uppsala County Council, Sweden
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    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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