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Sms Guided Training After Acute Stroke (StrokeWalk)

17. september 2017 oppdatert av: Birgit Vahlberg, Uppsala County Council, Sweden

Sms Guided Training After Acute Stroke: A Pilot Study

The purpose of this exploratory study is to investigate how a predetermined outdoor walking program (12 weeks) is best delivered to individuals with stroke over 18 years, either by smartphone and the Short Message Service (SMS) or video link.

Furthermore, the aim is to investigate how the study design works in practice and determine the effects of the outdoor walking exercise program in combination with a leg exercise on physical functioning (walking capacity, gait speed, mobility and grip strength).

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Twenty community-living individuals in Uppsala municipality will be included and treated with a cross-over design. Ten individuals will initially receive exercise instructions to their smartphones via Short Message Service (SMS) for 6 weeks and after that instructions by a video link (6 weeks). Another 10 individuals will initially receive instructions by a video link and then switching to management with SMS after 6 weeks of training.

Intervention: Participants are supposed to perform an outdoor walking exercise program for 12 weeks. The walks should gradually increase in frequency and intensity, and is expected to start after discharge from the stroke department, after the assessment. The first 2 weeks start with daily walks. The walks will be conducted at a pace that increases the heart rate but still makes it possible to talk. 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, which should be performed in connection with the walk training.

Methods: 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 are only performed as screening at baseline measurements. Objective evaluation of the participants' adherence to the outdoor walking program will be measured with a training diary where the individual documents whether they have followed the training instructions.

Power analysis is not performed since this is an exploratory study. The investigators will analyze the data using an intention-to -treat. The investigators will also do a 'per-protocol analysis, where only participants who completed the training are included. Participants should have participated in at least 50% of the training sessions. All analyzes will be done using SPSS version 23 (IBM, Armonk).

Studietype

Intervensjonell

Registrering (Faktiske)

19

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. ≥ 18 years
  2. Verified ischemic cerebral infarction or intracerebral hemorrhage.
  3. Sufficient walking capacity and motor function
  4. Able to communicate in Swedish
  5. Signed consent

Exclusion Criteria:

Are 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Training after acute stroke
Intervention: Outdoor walking and strength training.
Outdoor walking: Participants will receive daily training instructions via Short message Service (SMS) over 12 weeks. The walks are increased in frequency and intensity. The intensity are rated using the Borg scale to 12-15. The first 2 weeks begins with daily walks of 10 minutes. The last 4 weeks the walk training will partly be performed in intervals in combination with conventional outdoor walks. The interval training includes warming-up (5 minutes), fast walking for 4 minutes alternated with slower walking for three minutes. This is repeated 3 times, followed by cooling down for about five minutes. Strength training: to repeatedly get up from sitting. Number of repetitions will increase from 5-20 per set and will be performed daily in 3 sets with a short rest between each set.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6 Minutes Walk Test
Tidsramme: change from baseline walking capacity to three months
walking capacity
change from baseline walking capacity to three months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Short Physical Performance Battery
Tidsramme: change from baseline mobility to three months
mobility
change from baseline mobility to three months
10 meters walk test
Tidsramme: change from baseline gait speed to three months
gait speed
change from baseline gait speed to three months
Montreal Outcome Assessment
Tidsramme: baseline
cognitive function
baseline
Modified Rankin Scale
Tidsramme: baseline
motor function
baseline
Saltin Grimby Physical Activity Level Scale
Tidsramme: baseline
level of physical activity
baseline
Jamar hand dynamometer
Tidsramme: change from baseline hand-grip strength to three months
hand-grip strength
change from baseline hand-grip strength to three months
The Visual Analogue Rating Scale (VAS)
Tidsramme: change from six baseline to three months.
Report of how to deliver the best instructions.
change from six baseline to three months.
The Visual Analogue Rating Scale (VAS)
Tidsramme: change from baseline to three months.
Report of how to deliver the best instructions.
change from baseline to three months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Birgit Vahlberg, Med Dr, RPT, VO Paramedicin

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2015

Primær fullføring (Faktiske)

1. juni 2016

Studiet fullført (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først innsendt

16. mars 2016

Først innsendt som oppfylte QC-kriteriene

24. mars 2016

Først lagt ut (Anslag)

25. mars 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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