- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02661906
A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days
Effect of SKY on Anxiety, Depression and Quality of Life of Type 2 Diabetic Patients After a 6 Days Intervention
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Diabetes is a psychologically and behaviorally demanding disease; therefore psychosocial factors are relevant to nearly all aspects of its management. Research findings have demonstrated that depression is more common in patients with diabetes than in the general population, at least 15 % of patients have clinical depression.Yoga is a mind-body alternative therapy which can be used to prevent and treat type 2 diabetes mellitus and related complications.
Sudarshan kriya Yoga is a unique yogic breathing practices which involves several types of cyclical breathing patterns, ranging from slow and calming to rapid and stimulating. It is recommended for relaxation, stress management, control of psycho physiological states and to improve organ function. In this pilot study Investigator recruited 24 type 2 diabetic patient and those who consent were provided with 6 days yoga course for a duration of 3 hours and trained to practice SKY at home for 12 week. At baseline and after 6 days of SKY, questionnaire on anxiety, depression and quality of life were provided to them. Biochemical parameters were measured at baseline and after 12 weeks of yoga. Two follow up yoga session were provided to the participants. Primary outcome were pre to post intervention change in the mental health and quality of life.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Kuwait, Kuwait, 1180
- Dasman Diabetes Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria
- 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.
Exclusion criteria
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: SKY Pre
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.
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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.
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Aktiv komparator: SKY post
The enrolled participants were provided with SKY intervention and their pre and post data were recorded.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Improvement in quality of life
Tidsramme: at 12 week
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change in score of Questionnaires on anxiety at 12 week of yoga intervention
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at 12 week
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Improvement in HbA1c
Tidsramme: at12 week of intervention
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Change in HbA1c value at 12 week of yoga intervention
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at12 week of intervention
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Improvement in BMI
Tidsramme: at 12 week of intervention
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Change in BMI at 12 week of yoga intervention
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at 12 week of intervention
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Improvement in lipid profile
Tidsramme: at 12 week of intervention
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Change in lipid levels at 12 week of yoga intervention
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at 12 week of intervention
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rashmi Shiju, Mpharm, Dasman Diabetes Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RA 2014-028
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