A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days

NCT02661906 | Completed

• 1 other identifier: RA 2014-028
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

• Improvement in quality of life

  change in score of Questionnaires on anxiety at 12 week of yoga intervention

  at 12 week

Secondary Outcomes (3)

• Improvement in HbA1c

  at12 week of intervention

• Improvement in BMI

  at 12 week of intervention

• Improvement in lipid profile

  at 12 week of intervention

Study Arms (2)

SKY Pre

EXPERIMENTAL

Sudarshan Kriya Yoga is provided to all the enrolled participants. The baseline characteristics of patient is compared with that of their characteristics after yoga intervention. All the participants were provided with yoga training for 6 days and then asked to perform the SKY at home daily till 12 week. The questionnaire on anxiety, depression and quality of life were administered at the baseline and at the end of 6 days of yoga. Biochemical parameters such as HbA1c, lipid profile, fasting glucose and post meal glucose were measured at baseline and after 12 week of intervention.

Other: SKY

SKY post

ACTIVE COMPARATOR

The enrolled participants were provided with SKY intervention and their pre and post data were recorded.

Other: SKY

Interventions

SKY OTHER

Sudarshan Kriya Yoga is a rhythmic breathing exercise with slow and fast breath at a particular pace.It is recommended for stress management as yoga is a mind body control tool. SKY is having effect on multiple organ thus causing the positive effect.

SKY Pre; SKY post

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients showing stress as per the stress indicators.
• Patients of both gender of age 30 to 65 years on oral anti diabetic agents
• Patient is able to perform yoga postures and breathing exercise.
• Patient is able to consent for the study.
• Patient should be able to understand English as that is the medium used.

You may not qualify if:

• Bipolar disorder
• Antidepressant drugs
• Type 1 diabetes
• Pregnancy
• Any acute coronary symptoms in past 6 months
• Artificial pace-maker
• Previous (SKY) or any type of spiritual meditation practiced within 6 months

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, 1180, Kuwait

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rashmi Shiju, Mpharm

  Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: January 25, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 12, 2019

Record last verified: 2016-08

Locations

KU (1)