- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302535
The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension (YHIP)
The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension - a Randomised Controlled Trial in Primary Health Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypertension is one of the most common diseases in the industrialized world. In Sweden alone approximately 1.8 million persons, 25% of the adult population, have hypertension. Hypertension is a common diagnosis in primary health care and the costs of investigating and treating hypertension and its consequences are considerable. We know that stress can affect blood pressure, but it is hard to measure and control.
Previous studies have separately shown that yoga can reduce levels of cortisol in saliva and lower blood pressure. However, few studies have investigated the effects of yoga on hypertension and we lack information about the possibility of using yoga in primary health care to reduce hypertension.
If yoga can be used to complement antihypertensive medicines, it could reduce medicine intake and thereby possibly reduce side effects and lower medicine costs. It is to be hoped that patients will also experience a higher quality of life if they perform yoga on a regular basis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Malmö, Sweden, 20502
- Center for Primary Health Care Research, Lunds University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with hypertension since at least one year.
- Blood pressure 120/80-160/100 mmHg at the last blood pressure control by doctor or nurse.
Exclusion Criteria:
- Blood pressure >180 systolic and/or >110 diastolic by the initial control in the study.
- Blood pressure <120 systolic by the initial control in the study.
- 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
- Older than 80 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Yoga group with supervision/trainer
|
The Yoga-with-trainer group will meet once a week (60 minutes) to practice yoga with a yoga instructor.
The participants will be encouraged to practice yoga between the yoga classes at home for 30 minutes a day.
|
|
Active Comparator: Yoga at home
|
The participants in the Yoga-at-home group will get a private doctor appointment (20 minutes) where they get instructions for two yoga exercises which they are encouraged to perform at home 15 minutes a day.
|
|
No 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 groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hypertension
Time Frame: 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.
Blood samples will also be collected and analysed in the beginning and at the end of the study.
Some blood samples will be preserved for future analysis.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: 12 weeks
|
At the beginning of the study, all subjects will be requested to fill in a questionnaire about their quality of life (WHOQOL-BREF).
After 12 weeks all subjects in the intervention and control groups will fill in the quality of life-form for a second time.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Moa Wolff, MD, Center for Primary Health Care Research, Lunds University
Publications and helpful links
General Publications
- Wolff M, Memon AA, Chalmers JP, Sundquist K, Midlov P. Yoga's effect on inflammatory biomarkers and metabolic risk factors in a high risk population - a controlled trial in primary care. BMC Cardiovasc Disord. 2015 Aug 19;15:91. doi: 10.1186/s12872-015-0086-1.
- Wolff M, Sundquist K, Larsson Lonn S, Midlov P. Impact of yoga on blood pressure and quality of life in patients with hypertension - a controlled trial in primary care, matched for systolic blood pressure. BMC Cardiovasc Disord. 2013 Dec 7;13:111. doi: 10.1186/1471-2261-13-111.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/728
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
Clinical Trials on Yoga group with supervision (trainer)
-
Diakonhjemmet HospitalRecruitingExercise | SpondyloarthritisNorway
-
University of PotsdamSwiss Council for Accident Prevention; Prof. Dr. Reto W. Kressig and Dr. Yves...CompletedFall Prevention | Fall Risk FactorsGermany
-
Botec Analysis, LLCPennsylvania Department of Corrections; Bureau of Justice AssistanceUnknownSubstance Abuse | Criminal Behavior
-
Chang Gung Memorial HospitalUnknown
-
University of California, San FranciscoMount Zion Health Fund; Pritzker Family Foundation; Mental Insight FoundationCompletedDepression, UnipolarUnited States
-
University of NottinghamCompleted
-
University of OsloCompletedMental Health | Depression, Anxiety | Sleep Problem | Public Health | University StudentsNorway
-
Beijing Friendship HospitalRecruiting
-
Colorado State UniversityCompleted
-
Jenilee SneedWithdrawnPsychological Distress | Mindfulness