- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Malmö, Suède, 20502
- Center for Primary Health Care Research, Lunds University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Hypertension
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Qualité de vie
Délai: 12 semaines
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Au début de l'étude, tous les sujets seront invités à remplir un questionnaire sur leur qualité de vie (WHOQOL-BREF).
Après 12 semaines, tous les sujets des groupes d'intervention et de contrôle rempliront la forme de qualité de vie une seconde fois.
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12 semaines
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Stress
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Moa Wolff, MD, Center for Primary Health Care Research, Lunds University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Region Skane
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