Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension (YHIP2)
Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension - A Randomized Controlled Multicenter Trial in Primary Care
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Malmö, Zweden, 20502
- Center for Primary Health Care Research, Lunds University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: 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.
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Actieve vergelijker: yoga
Two yoga exercises to perform at home 15 minutes twice daily.
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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:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Hypertension
Tijdsspanne: 12 weeks
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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
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12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Kwaliteit van het leven
Tijdsspanne: 12 weken
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Aan het begin van het onderzoek wordt aan alle proefpersonen gevraagd een vragenlijst in te vullen over hun kwaliteit van leven (WHOQOL-BREF).
Na 12 weken vullen alle proefpersonen in de interventie- en controlegroep voor de tweede keer het formulier kwaliteit van leven in.
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12 weken
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Stress
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Anxiety and depression
Tijdsspanne: 12 weeks
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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.
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12 weeks
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Moa Wolff, MD, Center for Primary Health Care Research, Lunds University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Region Skane
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