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Trial record 58 of 662 for:    SMS

Sms-guided Training After Acute Stroke or Transient Ischemic Attack - a Randomized Controlled Trial (SMS/TIA)

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ClinicalTrials.gov Identifier: NCT02902367
Recruitment Status : Unknown
Verified September 2017 by Birgit Vahlberg, Uppsala County Council, Sweden.
Recruitment status was:  Recruiting
First Posted : September 15, 2016
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Birgit Vahlberg, Uppsala County Council, Sweden

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.

Condition or disease Intervention/treatment Phase
Acute Stroke TIA (Transient Ischemic Attack) Other: Outdoor walking and strength exercise Other: control group Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial
Study Start Date : November 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention:
Outdoor walking and strength exercise, Three months, daily SMS.
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.
Other Name: exercise

Control group
Usual care; no restriction for exercise, Three months
Other: control group
Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.
Other Name: control




Primary Outcome Measures :
  1. 6 minute walk test (6MWT) [ Time Frame: from baseline walking capacity to three months ]
    walking capacity


Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: from baseline SPPB to three months ]
    mobility

  2. 10 meter walk test (10mWT) [ Time Frame: from baseline 10mWT to three months ]
    gait speed

  3. Hand-dynamometer (Jamar) [ Time Frame: from baseline Jamar to three months ]
    hand-grip strength

  4. Body composition (bioelectric impedance analysis) [ Time Frame: from baseline body composition to three months ]
    muscles and fat mass and BMI

  5. Cardiometabolic risk markers [ Time Frame: from baseline cardiometabolic risk markers to three months ]
    blood lipids, c-reactive proteins (CRP), blood glukos, HbA1c, Insulin-like growth factor (IGF-1), Interleukin-6 (Il-6)

  6. Heart and lung foundation stress test [ Time Frame: at baseline ]
    self-perceived stress

  7. Food frequency questionnaire [ Time Frame: at baseline ]
    self-reported food intake and quality

  8. Montreal outcome assessment (MoCA) [ Time Frame: at baseline ]
    cognition

  9. Modified rankin scale (MRS) [ Time Frame: at baseline ]
    motor function

  10. Mortality [ Time Frame: from baseline to 1 year ]
    register-based mortality

  11. Health-related quality of life [ Time Frame: from baseline to 1 year ]
    register-based quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902367


Contacts
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Contact: Birgit Vahlberg, Med Dr, RPT +46709583473 birgit.vahlberg@pubcare.uu.se
Contact: Tommy Cederholm, Professor,MD +46702733192 tommy.cederholm@pubcare.uu.se

Locations
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Sweden
Birgit Vahlberg Recruiting
Uppsala, Sweden, 75185
Contact: Birgit Vahlberg, Med Dr, RPT    +18709583473    birgit.vahlberg@pubcare.uu.se   
Contact: Tommy Cederholm, Professor    +18702733192    tommy.cederholm@pubcare.uu.se   
Sponsors and Collaborators
Uppsala County Council, Sweden
Investigators
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Principal Investigator: Birgit Vahlberg Sweden,Uppsala Uppsala University Hospital

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Responsible Party: Birgit Vahlberg, Md Dr, RPT, Uppsala County Council, Sweden
ClinicalTrials.gov Identifier: NCT02902367     History of Changes
Other Study ID Numbers: UppsalaCC2
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Birgit Vahlberg, Uppsala County Council, Sweden:
mobility
exercise
walking capacity
fat mass
muscles
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia