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.

Abstract

Background: High blood pressure (BP) is a common condition that is estimated to soon affect one third of the worlds' population. Poor subjective sleep quality is shown to be associated with an elevated risk of high BP, though it is a risk factor that can be modified. Yoga can be used as a complementary therapy to lower BP, but more knowledge on duration and intensity are needed. The overall aim is to test the effect of an online yoga intervention as a complementary therapy. The objectives are to: (1) Test whether online yoga can improve sleep quality, health related quality of life, and lower BP. (2) To explore and describe the implementation of online yoga and the participants' experiences and perspectives on the intervention in a process evaluation.

Methods: A pragmatic randomized controlled trial will be conducted. The study is described in accordance with the SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials) and results will be reported following the CONSORT (CONsolidated Standards Of Reporting Trials) guidelines for pragmatic trials. The study is designed as a three arm, randomized superiority trial.

Inclusion criteria: ≥65 years old, diagnosed with high BP, speaking and reading Danish, able to consent, no comorbidity that restricts them from participating in the intervention, and daily access to a smartphone or tablet. Participants will be randomly assigned to (i) control group which will be receiving treatment as usual (TAU), or to one of two intervention-groups (ii) performing yoga twice a week for 20 min (20 MIN) or (iii) 40 min (40 MIN) for a total of 10 weeks in addition to TAU. The primary outcome is sleep quality measured by the Pittsburg Sleep Quality Index and secondary outcomes include health related quality of life and BP. Analysis will present differences between groups and be carried out by a statistician blinded to group allocation.

Discussion: The study is grounded in the urgent need to address high BP since pharmacological interventions remain the primary treatment modality, the exploration of non-pharmacological strategies, such as yoga, offers a promising avenue for enhancing patient outcomes in a holistic manner.

Trial registration: ClinicalTrials.gov ID NCT06553820. Protocol version 1. 13th November 2024.