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Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension (YHIP2)

4. november 2014 opdateret af: Moa Wolff, Region Skane

Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension - A Randomized Controlled Multicenter Trial in Primary Care

The purpose of this study is to determine the effects of a short yoga program practiced daily at home on blood pressure, quality of Life and stress. The subjects of the study are primary health care patients diagnosed with hypertension, with or without current medication.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Hypertension is one of the most common diseases in the world, affecting approximately 26% of the adult population. Persistent hypertension increases the risk of developing coronary heart disease, stroke and other cardiovascular diseases, such as heart failure. Hypertension is a common diagnosis in primary health care and the societal costs of examination and treatment of hypertension and its consequences are considerable.

The YHIP-study (The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension), that investigated yoga as additional treatment for hypertension on primary care patients, showed that a short yoga program practiced daily at home had a blood pressure lowering effect as well as a positive effect on self-rated quality of life compared to control.

Other previous studies have demonstrated positive effects of yoga on blood pressure, quality of life, subjective well-being and stress. However, these studies are relatively few and we need to further investigate the possibility of using yoga as a treatment in primary health care.

If the yoga intervention shows to be effective, yoga exercises may be useful as a supplementary BP therapy in addition to medical treatment when prescribed by primary care physicians. It is to be hoped that patients will also experience a higher quality of life and less stress if they perform yoga on a regular basis.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

190

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sverige
      • Malmö, Sverige, 20502
        • Center for Primary Health Care Research, Lunds University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 30-80 years old
  • Diagnosed with hypertension since at least one year
  • Blood pressure 130-160 mm Hg systolic and/or 85-100 diastolic at the last blood pressure control by doctor or nurse.
  • Blood pressure within inclusion- and exclusion-limits at baseline control

Exclusion Criteria:

  • Blood pressure outside the range of 120-180 systolic and 80-110 diastolic at the last blood pressure control or at baseline control.
  • Medical adjustments regarding hypertension within 4 weeks prior to begin of study.
  • Expected inability to understand instructions about yoga exercises (e.g dementia and mental retardation) or physical or psychical inability to carry out yoga exercises (e.g severe physical or psychical handicap).
  • Need for interpreter. Linguistic/language difficulties

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
No changes will be made for the participants in the control group, but they will undergo the same measurements and evaluations as the intervention group.
Aktiv komparator: yoga
Two yoga exercises to perform at home 15 minutes twice daily.
Andet: Yoga

The participants in the Yoga group will get a private doctors appointment (20 minutes) where they get instructions for two yoga exercises to perform at home 15 minutes twice a day.

The two yoga exercises were:

  1. "Left nostril breathing" - deep breaths in and out through the left nostril while sitting or lying down, with the right nostril closed off by the right thumb or an earplug (about 11 minutes); and
  2. "Spinal flex" - movement that alternates between flexing the spine forwards (arching) and relaxing the spine back in time with deep breaths while sitting in a chair (about 4 minutes).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hypertension
Tidsramme: 12 weeks
At the beginning of the study, all subjects will undergo a standardized blood pressure test with an hypertension monitor. After 12 weeks, all subjects in the intervention and control groups will again be requested to attend a blood pressure testing session
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Livskvalitet
Tidsramme: 12 uger
I begyndelsen af ​​undersøgelsen vil alle forsøgspersoner blive bedt om at udfylde et spørgeskema om deres livskvalitet (WHOQOL-BREF). Efter 12 uger vil alle forsøgspersoner i interventions- og kontrolgrupperne udfylde livskvalitetsformen for anden gang.
12 uger

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stress
Tidsramme: 12 weeks
At the beginning of the study, all subjects will be requested to fill in a questionnaire about their self-rated stress(PSS). After 12 weeks all subjects in the intervention and control groups will fill in the stress-questionnaire once again.
12 weeks
Anxiety and depression
Tidsramme: 12 weeks
At the beginning of the study, all subjects will be requested to fill in a questionnaire with questions regarding anxiety and depression(HAD). After 12 weeks all subjects in the intervention and control groups will complete the questionnaire once again.
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Region Skane

Samarbejdspartnere

The Swedish Research Council

Efterforskere

  • Ledende efterforsker: Moa Wolff, MD, Center for Primary Health Care Research, Lunds University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2013

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

8. november 2013

Først indsendt, der opfyldte QC-kriterier

8. november 2013

Først opslået (Skøn)

14. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Region Skane

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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