HypertensionYHIPNCT01302535
The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension
A study testing Yoga group with supervision (trainer) and Yoga at home in people with Hypertension, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to determine the effects of yoga on blood pressure and quality of life in patients in primary health care diagnosed with hypertension within the last year. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Yoga group with supervision (trainer) and Yoga at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Primary Health Care Research, Lunds University
Malmö, 20502
About this study
Official title: The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension - a Randomised Controlled Trial in Primary Health Care
The purpose of this study is to determine the effects of yoga on blood pressure and quality of life in patients in primary health care diagnosed with hypertension within the last year. Another purpose is to examine whether the possible effect on blood pressure differs if patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from their doctor to be practiced individually at home.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Yoga group with supervision (trainer), Yoga at home
- Keywords
- Yoga, Hypertension, Quality of Life, Primary Health Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga group with supervision (trainer)Other
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.
Yoga at homeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group with supervision/trainer | Active comparator | Not described Receives: Other: Yoga group with supervision (trainer) |
| Yoga at home | Active comparator | Not described Receives: Other: Yoga at home |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Hypertension
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.
Measured: 12 weeks
Secondary outcomes (1)
Quality of life
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Moa Wolff, Region Skane
- Investigators
- Moa Wolff, MD, Principal investigator, Center for Primary Health Care Research, Lunds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302535
- Sponsor's protocol ID
- 2010/728
- Acronym
- YHIP
- Status last verified
- Feb 2012
- First submitted
- 22 Feb 2011
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26286137Wolff 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.
PubMed 24314119
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension - a Randomised Controlled Trial in Primary Health Care
- ClinicalTrials.gov ID
- NCT01302535
- Acronym / sponsor ID
- YHIP / 2010/728
- Conditions
- Hypertension
- Keywords
- Yoga, Hypertension, Quality of Life, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of yoga on blood pressure and quality of life in patients in primary health care diagnosed with hypertension within the last year. Another purpose is to examine whether the possible effect on blood pressure differs if patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from their doctor to be practiced individually at home.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga group with supervision/trainer | Active comparator | Other: Yoga group with supervision (trainer) |
| Yoga at home | Active comparator | Other: Yoga at home |
| Control | No intervention | –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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Yoga group with supervision/trainer |
| Yoga at homeThe 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. | Other | Yoga at home |
Primary outcome
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.
1 secondary outcome
Quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- Derived from this study: PubMed 26286137Wolff 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.
- Derived from this study: PubMed 24314119Wolff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moa Wolff, MD principal investigator
Center for Primary Health Care Research, Lunds University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga group with supervision (trainer) and Yoga at home in people with Hypertension, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01302535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.