Effect of Yogic Intervention on Heart Rate Variability, Cognition and Stress Parameters in Hypothyroid Patients:A Randomized Controlled Trial.

Study title: EFFECT OF YOGIC INTERVENTION ON HEART RATE VARIABILITY, COGNITION AND STRESS PARAMETERS IN HYPOTHYROID PATIENTS.

Rationale: Hypothyroid patients had increased risk of coronary heart disease events, heart failure, and cardiovascular mortality among affected adults. Sympathovagal imbalance, cognitive impairment and higher stress have been reported in hypothyroid patients. Exploring the role of yogic intervention in hypothyroid patients on Heart rate variability, cognition and stress reduction can be helpful in the management of these patients.

Aim: To assess the effect of yogic intervention on Heart Rate Variability, Cognition and Stress parameters in Hypothyroid Patients.

OBJECTIVES:

1. To determine the effect of yogic intervention on Heart Rate Variability in hypothyroid patients.

2. To determine the effect of yogic intervention on Cognition through Cognition Self- Assessment Rating Scale (C-SARS) in hypothyroid patients.

3. To determine the effect of yogic intervention on Stress Parameters through Perceived Stress Scale (PSS) in hypothyroid patients.

Study type: Prospective, Interventional Study

Study design: Randomised Controlled Trial study

Time frame: April 2024 to August 2025

Population /participants: Diagnosed Hypothyroid patients (TSH>10µIU) will be taken from Endocrinal OPD, Centre for Diabetes, Endocrinology & Metabolism, Delhi

Sample size: 30 subjects in two groups (Total=60)

Grouping of Subjects:

Group I- Patients on conventional treatment and yogic intervention

Group II- Patients on conventional treatment only

Even on extensive search we could not find any article where the HRV and other parameters have been studied after yogic intervention in hypothyroid patients. Due to this paucity of literature we could not calculate the sample size, therefore a convenient sample of 30 subjects in group I and 30 subjects in group II will be taken in this study. The total 60 subjects will be randomized among two groups as per computer generated random number technique.

Methods: Hypothyroid patients (TSH>10µIU) included in this study will undergo brief history taking, physical, clinical and anthropometric assessment prior to the participation. After the clinical evaluation is complete, hypothyroid patients who fulfil the inclusion & exclusion criteria and who sign the informed consent will be recruited for the study. Both groups will undergo HRV recording and assessment of cognition using the Cognition Self-Assessment Rating Scale (C-SARS) and Stress using the Perceived Stress Scale (PSS).

Outcome measures:

•       Changes in HRV parameters.

•       Changes in cognition scores.

•       Changes in stress parameter.

Statistical analysis:

•       Analysis will be done using SPSS 20.0 statistical software.

•       Between and within the group comparison will be done by unpaired and paired t-test.

•       P value of <0.05 will be considered significant.