The Effect of MediYoga on Sleep Quality, Blood Pressure, and Quality of Life in Older Adults with Hypertension:

November 11, 2024 updated by: Signe Stelling Risom, Herlev and Gentofte Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Control group, no intervention
standard of care
Other: Control Group, No intervention
standard of care only
Experimental: Intervention group I, yoga 20 minutes x2 pr week
Behavioral: Intervention group I, Yoga 20 minutes x2 pr week
App-based MediYoga exercises, 20 minutes per session, twice a week for a total of 10 weeks.
Experimental: Intervention Group II, yoga 40 minutes pr week
Behavioral: Intervention Group II, Yoga 40 minutes x2 pr week
App-based MediYoga exercises, 40 minutes per session, twice a week for a total of 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 10 weeks
Reducing BP measured by self-monitoring in own home. Both Systolic blood pressure and diastolic blood pressure will be measured.
10 weeks
Health-related quality of life
Time Frame: 10 weeks
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
10 weeks
Mental health
Time Frame: 10 weeks
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev and Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24000021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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