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

NCT06553820 | Recruiting DMC

• 1 other identifier: H-24000021
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension; Quality of Life; Quality of Sleep; Mental Health

Keywords

MediYoga; Hypertension; Mindfulness; Quality of life

Outcome Measures

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 .

  10 weeks

Secondary Outcomes (3)

• Blood pressure

  10 weeks

• Health-related quality of life

  10 weeks

• Mental health

  10 weeks

Study Arms (3)

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

standard of care

Other: Control Group, No intervention

Interventions

Intervention group I, Yoga 20 minutes x2 pr week BEHAVIORAL

App-based MediYoga exercises, 20 minutes per session, twice a week for a total of 10 weeks.

Intervention group I, yoga 20 minutes x2 pr week

Intervention Group II, Yoga 40 minutes x2 pr week BEHAVIORAL

App-based MediYoga exercises, 40 minutes per session, twice a week for a total of 10 weeks.

Intervention Group II, yoga 40 minutes pr week

Control Group, No intervention OTHER

standard of care only

Control group, no intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, Copenhagen, 2730, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40114123 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Interventions

Yoga; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Katrine Amdi, MSc

CONTACT

+4538673867; katrine.vollbrecht.amdi@regionh.dk

Signe Risom, associated Prof.

CONTACT

signe.stelling.risom@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: November 4, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

DK (1)