- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01984593
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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Malmö, Sverige, 20502
- Center for Primary Health Care Research, Lunds University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Hypertension
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Livskvalité
Tidsram: 12 veckor
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I början av studien kommer alla försökspersoner att uppmanas att fylla i ett frågeformulär om sin livskvalitet (WHOQOL-BREF).
Efter 12 veckor kommer alla försökspersoner i interventions- och kontrollgrupperna att fylla i livskvalitetsformuläret för andra gången.
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12 veckor
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Stress
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Moa Wolff, MD, Center for Primary Health Care Research, Lunds University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Region Skane
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