Yoga for heart attack and sleep quality

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: Eligible participants who give written consent for participation will be randomized into two arms, intervention and comparator groups, using a simple randomization method with an allocation ratio of 1:1. An independent statistician will generate the random allocation sequence. In addition to maintaining concealment, serial number‐specific opaque sealed envelopes will be maintained by a person who is not a part of the study. The current study is a non‐blinded trial; however, the outcome assessors will be blinded to the allocation of the subjects. Intervention group: ‘Yoga Nidra’+ 'Sleep hygiene' sessions for three months Comparator group: 'Sleep hygiene' sessions for three months Intervention detail: Yoga Nidra is a simple method of relaxation practised in the flat lying position of ‘Shavasana’ (lying on the back, the arms and legs are spread at about 45 degrees) and following the instructions of the trained yoga therapist. The therapist guides the participants into progressively deeper states of relaxation and self‐awareness. Participants are instructed to focus on each body part while breathing normally. Participants are asked not to sleep during the session and follow the instructions provided by the yoga instructor. The yoga classes for the patients consist of 30 to 35 minute /day sessions, five days a week. Total nine sessions [ three sessions (in‐person guidance/contact session) and si Xsessions (supervised online session). Duration of Yoga Protocol: 30 ‐ 35 minutes. Sleep hygiene details: An experienced sleep expert will administer the Ten Commandments of Healthy Sleep in a personal interactive session (approximately ten minutes) at baseline. CONDITION: ICD‐10 condition:125.1, Atherosclerotic heart disease of native coronary artery ; Circulatory System PRIMARY OUTCOME: Sleep quality measured using an actigraphy at baseline and after 3 months SECONDARY OUTCOME: The following secondary outcome measures will be assessed at baseline and after 3 months:; 1. Total Sleep time (night), total sleep time (24 hours), sleep latency, and Sleep fragmentation inde Xmeasured using an actigraphy; 2. Daytime blood pressure (BP), 24‐hour and mean BP reduction, and nocturnal dip in systolic BP measured using ambulatory blood pressure monitoring (ABPM); 3. Diastolic function measured using echocardiography; 4. Improvement in quality of life measured using the Short‐Form‐36 questionnaire (SF 36); 5. Mental well‐being measured using Beck's Depression Inventory; 6. Reduction in salivary cortisol levels measured using electrochemiluminescence immunoassay (ECLIA)/ enzyme‐linked immunosorbent assay(ELISA)/ liquid chromatography‐mass spectrometry (LC‐MS); 7. Change in angina class, antianginal medications, hospitalization or physician contact for worsening of symptoms measured using clinical interviews INCLUSION CRITERIA: 1. Patient with age group of 30 – 80 years old 2. Both sexes 3. Patient with coronary artery disease, either with Chronic coronary syndrome or after 4 months of Acute coronary syndrome. 4. Patients who are not planned for revascularization. 5. Patients who were revascularized at least 6 weeks back CCS Angina = II.
Epistemonikos ID: e8355fd25cdec33f20c365e5e3e5cbeab7fc2392
First added on: Aug 28, 2024