Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial

Acute Stroke Clinical Trial

— SMS/TIA  

Official title:

Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02902367
• Other study ID #: UppsalaCC2
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2016
• Last updated: September 17, 2017
• Start date: November 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2017
• Source: Uppsala County Council, Sweden
• Contact: Birgit Vahlberg, Med Dr, RPT
• Phone: +46709583473
• Email: birgit.vahlberg[@]pubcare.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Stroke
• Ischemia
• Ischemic Attack, Transient
• Stroke
• TIA (Transient Ischemic Attack)

Intervention

Other:
• Outdoor walking and strength exercise
Exercise group: Participants are supposed to perform an outdoor walking exercise program and one strength exercise for 12 weeks. The first 2 weeks start with daily walks. 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, i.e. chair-rising which also should be performed daily.
• control group
Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.

Locations

Country	Name	City	State
Sweden	Birgit Vahlberg	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test (6MWT)	walking capacity	from baseline walking capacity to three months
Secondary	Short Physical Performance Battery (SPPB)	mobility	from baseline SPPB to three months
Secondary	10 meter walk test (10mWT)	gait speed	from baseline 10mWT to three months
Secondary	Hand-dynamometer (Jamar)	hand-grip strength	from baseline Jamar to three months
Secondary	Body composition (bioelectric impedance analysis)	muscles and fat mass and BMI	from baseline body composition to three months
Secondary	Cardiometabolic risk markers	blood lipids, c-reactive proteins (CRP), blood glukos, HbA1c, Insulin-like growth factor (IGF-1), Interleukin-6 (Il-6)	from baseline cardiometabolic risk markers to three months
Secondary	Heart and lung foundation stress test	self-perceived stress	at baseline
Secondary	Food frequency questionnaire	self-reported food intake and quality	at baseline
Secondary	Montreal outcome assessment (MoCA)	cognition	at baseline
Secondary	Modified rankin scale (MRS)	motor function	at baseline
Secondary	Mortality	register-based mortality	from baseline to 1 year
Secondary	Health-related quality of life	register-based quality of life	from baseline to 1 year