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

U

Uppsala County Council, Sweden

Status

Unknown

Conditions

TIA (Transient Ischemic Attack)
Acute Stroke

Treatments

Other: Outdoor walking and strength exercise
Other: control group

Study type

Interventional

Funder types

Other

Identifiers

NCT02902367
UppsalaCC2

Details and patient eligibility

About

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.

Full 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

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Intervention:
Experimental group
Description:
Outdoor walking and strength exercise, Three months, daily SMS.
Treatment:
Other: Outdoor walking and strength exercise
Control group
Other group
Description:
Usual care; no restriction for exercise, Three months
Treatment:
Other: control group

Trial contacts and locations

1

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Central trial contact

Tommy Cederholm, Professor,MD; Birgit Vahlberg, Med Dr, RPT

Data sourced from clinicaltrials.gov

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