Clinical trial NCT02720276: Sms Guided Training After Acute Stroke
Official title: Sms Guided Training After Acute Stroke: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: stroke
exercise
walking
mobility
Lead sponsor: Uppsala County Council, Sweden
Sponsor class: OTHER_GOV
First posted: 2016-03-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 6 Minutes Walk Test
timeFrame: change from baseline walking capacity to three months
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: change from baseline mobility to three months
measure: 10 meters walk test
timeFrame: change from baseline gait speed to three months
measure: Montreal Outcome Assessment
timeFrame: baseline
measure: Modified Rankin Scale
timeFrame: baseline
measure: Saltin Grimby Physical Activity Level Scale
timeFrame: baseline
measure: Jamar hand dynamometer
timeFrame: change from baseline hand-grip strength to three months
measure: The Visual Analogue Rating Scale (VAS)
timeFrame: change from six baseline to three months.
measure: The Visual Analogue Rating Scale (VAS)
timeFrame: change from baseline to three months.
Other outcomes:
Locations:
Study officials:
affiliation: VO Paramedicin
name: Birgit Vahlberg, Med Dr, RPT
role: PRINCIPAL_INVESTIGATOR
References: