The Effect of MediYoga on Sleep Quality, Blood Pressure, and Quality of Life in Older Adults with Hypertension:
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHerlev and Gentofte Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older people ≥65 years
Diagnosed with hypertension.
Speaking and reading Danish.
Being able to consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention group I, Yoga 20 minutes x2 pr week
BehavioralApp-based MediYoga exercises, 20 minutes per session, twice a week for a total of 10 weeks.
Intervention Group II, Yoga 40 minutes x2 pr week
BehavioralApp-based MediYoga exercises, 40 minutes per session, twice a week for a total of 10 weeks.
Control Group, No intervention
Other interventionstandard of care only
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Intervention group I, yoga 20 minutes x2 pr weekExperimental treatment 1 intervention
Group B: Intervention Group II, yoga 40 minutes pr weekExperimental treatment 1 intervention
Group C: Control group, no interventionOther 1 intervention
Trial outcomes
Primary outcomes
1
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 .
Time frame
10 weeksSecondary outcomes
1
Blood pressure
Reducing BP measured by self-monitoring in own home. Both Systolic blood pressure and diastolic blood pressure will be measured.
Time frame
10 weeks2
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
Time frame
10 weeks3
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.
Time frame
10 weeksSponsors and contacts
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Source ClinicalTrials.gov