Clinical trial NCT02902367: Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial
Official title: Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stroke
TIA (Transient Ischemic Attack)
Keywords: mobility
exercise
walking capacity
fat mass
muscles
Lead sponsor: Uppsala County Council, Sweden
Sponsor class: OTHER_GOV
First posted: 2016-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eighty community-living individuals in Uppsala municipality will be included. Intervention: Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments, questionnaires and medical records. Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity, mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be documented.

Detailed description: Eighty community-living individuals in Uppsala municipality will be included in a randomized controlled trial with two arms.

Intervention: Participants will perform an outdoor walking exercise program together with one strength exercise for 12 weeks. The intensity and frequency of the training will progressively increase. Participants are supposed to walk and perform strength training 5-7 days/week.

Methods: Clinical assessments, 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, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity (primary outcome measure), mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be evaluated.

Power analysis is performed. The investigators will analyze the data using an intention-to -treat analysis. Participants should have participated in at least 50% of the training sessions

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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
4. Pacemaker (body composition measurements)

Primary outcomes:
measure: 6 minute walk test (6MWT)
timeFrame: from baseline walking capacity to three months
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: from baseline SPPB to three months
measure: 10 meter walk test (10mWT)
timeFrame: from baseline 10mWT to three months
measure: Hand-dynamometer (Jamar)
timeFrame: from baseline Jamar to three months
measure: Body composition (bioelectric impedance analysis)
timeFrame: from baseline body composition to three months
measure: Cardiometabolic risk markers
timeFrame: from baseline cardiometabolic risk markers to three months
measure: Heart and lung foundation stress test
timeFrame: at baseline
measure: Food frequency questionnaire
timeFrame: at baseline
measure: Montreal outcome assessment (MoCA)
timeFrame: at baseline
measure: Modified rankin scale (MRS)
timeFrame: at baseline
measure: Mortality
timeFrame: from baseline to 1 year
measure: Health-related quality of life
timeFrame: from baseline to 1 year
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Birgit Vahlberg
Study officials:
affiliation: Sweden,Uppsala Uppsala University Hospital
name: Birgit Vahlberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vahlberg BM, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Potential effects on cardiometabolic risk factors and body composition by short message service (SMS)-guided training after recent minor stroke or transient ischaemic attack: post hoc analyses of the STROKEWALK randomised controlled trial. BMJ Open. 2021 Oct 18;11(10):e054851. doi: 10.1136/bmjopen-2021-054851.
citation: Vahlberg B, Lundstrom E, Eriksson S, Holmback U, Cederholm T. Effects on walking performance and lower body strength by short message service guided training after stroke or transient ischemic attack (The STROKEWALK Study): a randomized controlled trial. Clin Rehabil. 2021 Feb;35(2):276-287. doi: 10.1177/0269215520954346. Epub 2020 Sep 18.