This trial is active, not recruiting.

Condition acute stroke
Treatment training after acute stroke
Sponsor Uppsala County Council, Sweden
Start date November 2015
End date May 2016
Trial size 19 participants
Trial identifier NCT02720276, UppsalaCC


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Intervention: outdoor walking together with strength training.
training after acute stroke
Outdoor walking (10-30 minutes) together with strength training (chair-rising, 5-25 repetitions) six days/week during 12 weeks.

Primary Outcomes

6 Minutes Walk Test
time frame: change from baseline walking capacity to three months

Secondary Outcomes

Short Physical Performance Battery
time frame: change from baseline mobility to three months
10 meters walk test
time frame: change from baseline gait speed to three months
Montreal Outcome Assessment
time frame: baseline
Modified Rankin Scale
time frame: baseline
Saltin Grimby Physical Activity Level Scale
time frame: baseline
Jamar hand dynamometer
time frame: change from baseline hand-grip strength to three months
The Visual Analogue Rating Scale (VAS)
time frame: change from six weeks to three months.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Outdoor Walking and Strength Training After Acute Stroke: A Pilot Study
Principal investigator Birgit Vahlberg, Med Dr, RPT
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Uppsala County Council, Sweden.