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

NCT ID: NCT02902367

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-10-31

Brief Summary

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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

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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

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Acute Stroke TIA (Transient Ischemic Attack)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention:

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

Group Type EXPERIMENTAL

Outdoor walking and strength exercise

Intervention Type 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.

Control group

Usual care; no restriction for exercise, Three months

Group Type OTHER

control group

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

control group

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

Intervention Type OTHER

Other Intervention Names

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exercise control

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role lead

Responsible Party

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Birgit Vahlberg

Md Dr, RPT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgit Vahlberg

Role: PRINCIPAL_INVESTIGATOR

Sweden,Uppsala Uppsala University Hospital

Locations

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Birgit Vahlberg

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Birgit Vahlberg, Med Dr, RPT

Role: CONTACT

+46709583473

Tommy Cederholm, Professor,MD

Role: CONTACT

+46702733192

Facility Contacts

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Birgit Vahlberg, Med Dr, RPT

Role: primary

+18709583473

Tommy Cederholm, Professor

Role: backup

+18702733192

References

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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.

Reference Type DERIVED
PMID: 38443081 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34663672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32942914 (View on PubMed)

Other Identifiers

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UppsalaCC2

Identifier Type: -

Identifier Source: org_study_id