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

Recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • Control group Other
    Other Names: control
    Intervention Desc: Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Usual care; no restriction for exercise, Three months
  • Outdoor walking and strength exercise Other
    Other Names: exercise
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Intervention
    Description: Intervention: outdoor walking and strength exercising delivered by SMS in 12 weeks.
    ARM 2: Kind: Experimental
    Label: Control
    Description: Control: Usual care; no restriction for exercise
    ARM 3: Kind: Experimental
    Label: Intervention:
    Description: Outdoor walking and strength exercise, Three months, daily SMS.
    ARM 4: Kind: Experimental
    Label: Control group
    Description: Usual care; no restriction for exercise, Three months

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 6 minute walk test (6MWT) from baseline walking capacity to three months No
Secondary Short Physical Performance Battery (SPPB) from baseline SPPB to three months No
Secondary 10 meter walk test (10mWT) from baseline 10mWT to three months No
Secondary Jamar hand dynamometer from baseline Jamar to three months No
Secondary Body composition (bioelectric impedance analysis and BodPod) from baseline body composition to three months No
Secondary Cardiometabolic risk markers from baseline cardiometabolic risk markers to three months No
Secondary Heart and lung foundation stress test at baseline No
Secondary Food frequency questionnaire at baseline No
Secondary Montreal outcome assessment (MoCA) at baseline No
Secondary Modified rankin scale (MRS) at baseline No
Secondary Mortality from baseline to 1 year No
Secondary Health-related quality of life from baseline to 1 year No
Secondary Hand-dynamometer (Jamar) from baseline Jamar to three months No
Secondary Body composition (bioelectric impedance analysis) from baseline body composition to three months No

Sponsors