HypertensionNCT06553820
The Effect of MediYoga on Sleep Quality, Blood Pressure, and Quality of Life in Older Adults With Hypertension:
A study testing Intervention group I, Yoga 20 minutes x2 pr week and Intervention Group II, Yoga 40 minutes x2 pr week in people with Hypertension and Quality of Life, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The goal of this Randomized Controlled Trial is to test if an intervention consisting of Yoga can increase quality of sleep and health related quality of life and decrease BP. Secondary to explore and describe the implementation of a yoga intervention and the participants' experiences and perspectives on the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Quality of Life, Quality of Sleep
- What is being tested?
- Intervention group I, Yoga 20 minutes x2 pr week and Intervention Group II, Yoga 40 minutes x2 pr week
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Nov 2024to 27 Jul 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older people ≥65 years
- Diagnosed with hypertension.
- Speaking and reading Danish.
- Being able to consent.
- No comorbidity that restricts them from participating in the intervention.
- Being the owner or user of a smartphone or tablet.
Who cannot join
- Starting an antihypertension medication during the intervention
- Antihypertension medication is changed (more than 10% increase or reduction in an already used drug or a switch to another drug) during the intervention, which includes diuretics, ACE inhibitors, Calcium-blockers, or Angiotensin-2-blockers.
- Participated in mindfulness or yoga exercise regularly at any point during the last two years.
- Patients who have diagnosed sleep disorders for example sleep apnea or narcolepsy.
- Taking sleep medication regularly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of MediYoga on Quality of Sleep, Blood Pressure and Quality of Life Among Older People: A Randomized Controlled Study
The goal of this Randomized Controlled Trial is to test if an intervention consisting of Yoga can increase quality of sleep and health related quality of life and decrease BP. Secondary to explore and describe the implementation of a yoga intervention and the participants' experiences and perspectives on the intervention in a process evaluation.
The main question it aims to contribute knowledge about intervention of Yoga in a home environment for individuals with hypertension aged 65 years or older. Participants will (if they got selected into one of the two interventions groups), participate in Yoga exercises delivered by an app for 2 times a week for 10 weeks. Researchers will compare the intervention groups with the control group to see if Medi yoga has an effect in older people with hypertension.
Read the detailed description
Hypertension is a common disease, and it is estimated that by 2025 one third of the world's population will have hypertension. The prevalence is increasing with age, and among older persons above the age of 90, 71% of women and 65 % of men have hypertension. Hypertension is related to cardiovascular illness, such as myocardial infarction, stroke, and death.
Poor subjective sleep quality has a significant association with an elevated risk of hypertension. Sleep disturbances are a significant risk factor for the development of depression in older adults. A recent review concluded that non-pharmacological interventions have the potential to improve self-reported sleep quality among older adults. There appears to be increasing evidence to support the long-term effect of virtual mindfulness-based interventions and their impact on sleep quality.
Several recent reviews have concluded that breathing exercises can be used as an alternative non-pharmacological therapy to lower blood pressure, but highlighted also that establish knowledge on duration and intensity needed to ensure the optimal effect.
The intervention follows the guidelines from MediYoga-MOSI, an evidence-based method developed in Sweden based on the classical kundalini tradition with elements from traditional Korean medicine and Ayurveda It has been adjusted to the Nordic context and is today used across the Swedish healthcare system.
The participants in the intervention group will participate in a breathing exercise, light yoga exercise and mindfulness intervention, as a review highlighted the effectiveness of combining these three elements. These programs will be translated into Danish and delivered via an app.
The participants will be randomly assigned to one of three groups: a control group, receiving usual care, or in one of two different intervention-groups in which the intervention takes place 2 times pr week for 10 weeks in addition to usual care. In group I the participants receive a 20-minute intervention, in group II the participants receive a 40-minute intervention. Participants receiving the intervention will be invited to participate online in follow-up sessions (after 2 and 6 weeks), where questions can be asked and adherence to intervention can be promoted
If the home-based MediYoga intervention proves effective, yoga exercises could serve as a supplementary treatment for blood pressure. Regular practice of MediYoga may also enhance patients' sleep quality and overall quality of life.
Statistical analysis will be performed using the Statistical Package for Social Sciences Program for the quantitative data. Descriptive statistics and inferential statistics will be used for data analysis. Descriptive statistics include frequency, percentage, mean and standard deviation, and inferential statistics include the chi-square test. The test of normality will be performed using the Shapiro-Wilk test. A paired t-test will apply to test for the significant differences within the groups and an unpaired t-test will be used to test for significant differences between the control and intervention groups. From comparable studies we expect an attrition rate of 50% since adherence to the intervention seem to be a challenge in comparable interventions where the patient must be physical active (like trials testing rehabilitation programs or yoga). Drop-out rate will be registered in a flowchart and both per protocol and intent-to-treat analyses will be performed. The level of significance was set as p<0.05. The analysis will be performed by a blinded statistician.
- Conditions
- Hypertension, Quality of Life, Quality of Sleep, Mental Health
- Being tested
- Intervention group I, Yoga 20 minutes x2 pr week, Intervention Group II, Yoga 40 minutes x2 pr week, Control Group, No intervention
- Keywords
- MediYoga, Hypertension, Mindfulness, Quality of life
- Medical subject headings
- Hypertension, Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group I, Yoga 20 minutes x2 pr weekBehavioural
App-based MediYoga exercises, 20 minutes per session, twice a week for a total of 10 weeks.
Intervention Group II, Yoga 40 minutes x2 pr weekBehavioural
App-based MediYoga exercises, 40 minutes per session, twice a week for a total of 10 weeks.
Control Group, No interventionOther
standard of care only
| Study group | Role | What they receive |
|---|---|---|
| Intervention group I, yoga 20 minutes x2 pr week | Experimental | Not described Receives: Behavioral: Intervention group I, Yoga 20 minutes x2 pr week |
| Intervention Group II, yoga 40 minutes pr week | Experimental | Not described Receives: Behavioral: Intervention Group II, Yoga 40 minutes x2 pr week |
| Control group, no intervention | Other | standard of care Receives: Other: Control Group, No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
Patient reported sleep quality measured on the PSQI (Pittsburg Sleep Quality Index). Minimum value: 0 Maximum value: 21 Higher scores: Indicate worse sleep quality The PSQI assesses sleep quality by compiling responses to questions covering various aspects of sleep, such as sleep duration, sleep problems, and daytime fatigue.
A total score of 5 or higher generally indicates poor sleep quality.
Between group change in baseline versus follow-up patient-reported sleep quality as assessed by the psqi questionnaire .
Measured: 10 weeks
Secondary outcomes (3)
Blood pressure
Reducing BP measured by self-monitoring in own home. Both Systolic blood pressure and diastolic blood pressure will be measured.
Measured: 10 weeks
Health-related quality of life
improving health-related quality of life measured by SF-12 questionnaire. Minimum Value: 0 Maximum Value: 100 Higher Scores Mean: Better health-related quality of life
Measured: 10 weeks
Mental health
with improving anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS) Minimum Value: 0 Maximum Value: 21 (for each subscale: anxiety and depression; the total score can range from 0 to 42) Higher Scores Mean: Worse anxiety or depression. HADS assesses levels of anxiety and depression through separate subscales for each condition.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start4 Nov 2024
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Stelling Risom, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553820
- Sponsor's protocol ID
- H-24000021
- Status last verified
- Nov 2024
- First submitted
- 8 Aug 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request
Publications
Risom SS, Amdi KV, Wahlstrom M, Rasmussen TB, Sharma S, Kabir ZN, Konradsen H. The effect of MediYoga on sleep-quality, blood pressure and quality of life among older people with hypertension: study protocol of a pragmatic randomized controlled trial. BMC Complement Med Ther. 2025 Mar 20;25(1):109. doi: 10.1186/s12906-025-04846-6.
PubMed 40114123
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of MediYoga on Quality of Sleep, Blood Pressure and Quality of Life Among Older People: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06553820
- Acronym / sponsor ID
- H-24000021
- Conditions
- Hypertension, Quality of Life, Quality of Sleep, Mental Health
- Keywords
- MediYoga, Hypertension, Mindfulness, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 14 Aug 2024 (actual)
- 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 goal of this Randomized Controlled Trial is to test if an intervention consisting of Yoga can increase quality of sleep and health related quality of life and decrease BP. Secondary to explore and describe the implementation of a yoga intervention and the participants' experiences and perspectives on the intervention in a process evaluation.
The main question it aims to contribute knowledge about intervention of Yoga in a home environment for individuals with hypertension aged 65 years or older. Participants will (if they got selected into one of the two interventions groups), participate in Yoga exercises delivered by an app for 2 times a week for 10 weeks. Researchers will compare the intervention groups with the control group to see if Medi yoga has an effect in older people with hypertension.
Detailed description
Hypertension is a common disease, and it is estimated that by 2025 one third of the world's population will have hypertension. The prevalence is increasing with age, and among older persons above the age of 90, 71% of women and 65 % of men have hypertension. Hypertension is related to cardiovascular illness, such as myocardial infarction, stroke, and death.
Poor subjective sleep quality has a significant association with an elevated risk of hypertension. Sleep disturbances are a significant risk factor for the development of depression in older adults. A recent review concluded that non-pharmacological interventions have the potential to improve self-reported sleep quality among older adults. There appears to be increasing evidence to support the long-term effect of virtual mindfulness-based interventions and their impact on sleep quality.
Several recent reviews have concluded that breathing exercises can be used as an alternative non-pharmacological therapy to lower blood pressure, but highlighted also that establish knowledge on duration and intensity needed to ensure the optimal effect.
The intervention follows the guidelines from MediYoga-MOSI, an evidence-based method developed in Sweden based on the classical kundalini tradition with elements from traditional Korean medicine and Ayurveda It has been adjusted to the Nordic context and is today used across the Swedish healthcare system.
The participants in the intervention group will participate in a breathing exercise, light yoga exercise and mindfulness intervention, as a review highlighted the effectiveness of combining these three elements. These programs will be translated into Danish and delivered via an app.
The participants will be randomly assigned to one of three groups: a control group, receiving usual care, or in one of two different intervention-groups in which the intervention takes place 2 times pr week for 10 weeks in addition to usual care. In group I the participants receive a 20-minute intervention, in group II the participants receive a 40-minute intervention. Participants receiving the intervention will be invited to participate online in follow-up sessions (after 2 and 6 weeks), where questions can be asked and adherence to intervention can be promoted
If the home-based MediYoga intervention proves effective, yoga exercises could serve as a supplementary treatment for blood pressure. Regular practice of MediYoga may also enhance patients' sleep quality and overall quality of life.
Statistical analysis will be performed using the Statistical Package for Social Sciences Program for the quantitative data. Descriptive statistics and inferential statistics will be used for data analysis. Descriptive statistics include frequency, percentage, mean and standard deviation, and inferential statistics include the chi-square test. The test of normality will be performed using the Shapiro-Wilk test. A paired t-test will apply to test for the significant differences within the groups and an unpaired t-test will be used to test for significant differences between the control and intervention groups. From comparable studies we expect an attrition rate of 50% since adherence to the intervention seem to be a challenge in comparable interventions where the patient must be physical active (like trials testing rehabilitation programs or yoga). Drop-out rate will be registered in a flowchart and both per protocol and intent-to-treat analyses will be performed. The level of significance was set as p<0.05. The analysis will be performed by a blinded statistician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group I, yoga 20 minutes x2 pr week | Experimental | Behavioral: Intervention group I, Yoga 20 minutes x2 pr week |
| Intervention Group II, yoga 40 minutes pr week | Experimental | Behavioral: Intervention Group II, Yoga 40 minutes x2 pr week |
| Control group, no intervention | Other | Other: Control Group, No interventionstandard of care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Older people ≥65 years
- Diagnosed with hypertension.
- Speaking and reading Danish.
- Being able to consent.
- No comorbidity that restricts them from participating in the intervention.
Key exclusion criteria (5 listed)
- Starting an antihypertension medication during the intervention
- Antihypertension medication is changed (more than 10% increase or reduction in an already used drug or a switch to another drug) during the intervention, which includes diuretics, ACE inhibitors, Calcium-blockers, or Angiotensin-2-blockers.
- Participated in mindfulness or yoga exercise regularly at any point during the last two years.
- Patients who have diagnosed sleep disorders for example sleep apnea or narcolepsy.
- Taking sleep medication regularly.
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 |
|---|---|---|
| Intervention group I, Yoga 20 minutes x2 pr weekApp-based MediYoga exercises, 20 minutes per session, twice a week for a total of 10 weeks. | Behavioural | Intervention group I, yoga 20 minutes x2 pr week |
| Intervention Group II, Yoga 40 minutes x2 pr weekApp-based MediYoga exercises, 40 minutes per session, twice a week for a total of 10 weeks. | Behavioural | Intervention Group II, yoga 40 minutes pr week |
| Control Group, No interventionstandard of care only | Other | Control group, no intervention |
Primary outcome
sleep quality
Time frame: 10 weeks
Patient reported sleep quality measured on the PSQI (Pittsburg Sleep Quality Index). Minimum value: 0 Maximum value: 21 Higher scores: Indicate worse sleep quality The PSQI assesses sleep quality by compiling responses to questions covering various aspects of sleep, such as sleep duration, sleep problems, and daytime fatigue. A total score of 5 or higher generally indicates poor sleep quality. Between group change in baseline versus follow-up patient-reported sleep quality as assessed by the psqi questionnaire .
3 secondary outcomes
Blood pressure
Time frame: 10 weeks
Health-related quality of life
Time frame: 10 weeks
Mental health
Time frame: 10 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 20 Aug 2026.
- Derived from this study: PubMed 40114123Risom SS, Amdi KV, Wahlstrom M, Rasmussen TB, Sharma S, Kabir ZN, Konradsen H. The effect of MediYoga on sleep-quality, blood pressure and quality of life among older people with hypertension: study protocol of a pragmatic randomized controlled trial. BMC Complement Med Ther. 2025 Mar 20;25(1):109. doi: 10.1186/s12906-025-04846-6.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group I, Yoga 20 minutes x2 pr week and Intervention Group II, Yoga 40 minutes x2 pr week in people with Hypertension and Quality of Life, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 6 inclusion and 5 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 20 Aug 2026. 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 Denmark. 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?
sleep quality (time frame: 10 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 NCT06553820, which also lists 1 linked publication.
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 20 Aug 2026.