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

NCT02902367 | Unknown

• 1 other identifier: UppsalaCC2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke; TIA (Transient Ischemic Attack)

Keywords

mobility; exercise; walking capacity; fat mass; muscles

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test (6MWT)

  walking capacity

  from baseline walking capacity to three months

Secondary Outcomes (11)

• Short Physical Performance Battery (SPPB)

  from baseline SPPB to three months

• 10 meter walk test (10mWT)

  from baseline 10mWT to three months

• Hand-dynamometer (Jamar)

  from baseline Jamar to three months

• Body composition (bioelectric impedance analysis)

  from baseline body composition to three months

• Cardiometabolic risk markers

  from baseline cardiometabolic risk markers to three months

Study Arms (2)

Intervention:

EXPERIMENTAL

Outdoor walking and strength exercise, Three months, daily SMS.

Other: Outdoor walking and strength exercise

Control group

OTHER

Usual care; no restriction for exercise, Three months

Other: control group

Interventions

Outdoor walking and strength exercise OTHER

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.

Also known as: exercise

Intervention:

control group OTHER

Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.

Also known as: control

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• One or more of the following:
• Subarachnoid bleeding
• Insufficient cognition and impaired ability to understand instructions
• Medical problems that make it unsuitable to participate
• Pacemaker (body composition measurements)

Sponsors & Collaborators

• Uppsala County Council, Sweden: lead

Study Sites (1)

Birgit Vahlberg

Uppsala, 75185, Sweden

RECRUITING

Related Publications (3)

• Vahlberg BM, Eriksson S, Holmback U, Lundstrom E. Factors associated with changes in walking performance in individuals 3 months after stroke or TIA: secondary analyses from a randomised controlled trial of SMS-delivered training instructions in Sweden. BMJ Open. 2024 Mar 4;14(3):e078180. doi: 10.1136/bmjopen-2023-078180.

  PMID: 38443081 DERIVED

• 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.

  PMID: 34663672 DERIVED

• 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.

  PMID: 32942914 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Motor Activity

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Birgit Vahlberg

  Sweden,Uppsala Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Vahlberg, Med Dr, RPT

CONTACT

+46709583473; birgit.vahlberg@pubcare.uu.se

Tommy Cederholm, Professor,MD

CONTACT

+46702733192; tommy.cederholm@pubcare.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md Dr, RPT

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: September 15, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

SE (1)