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Clinical Trials/CTRI/2022/02/040099
CTRI/2022/02/040099RecruitingNot Applicable

To evaluate the effects of Yoga on Cognitive function, activities of daily living, self-reported Depression, and Heart Rate Variability in subjects with Vascular Dementia

Central Council for Research in Yoga and Naturopathy Ministry of AYUSH1 site in 1 country104 target enrollmentStarted: February 14, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
104
Locations
1
Primary Endpoint
Cognitive Functions

Study Overview

Brief Summary

Yoga-based interventions appear to significantly improve several cognitive domains in elderly such as immediate and delayed recall, verbal and visual memory, attention, working memory, verbal fluency, executive function, and processing speed. Yoga has emerged as an effective and feasible add on therapy in schizophrenia, with special benefits in improving social cognition and negative symptoms. Yoga was found to benefit individuals with depressive symptoms, including quality of life and cognition. Some of the consistent effects of yoga practice include stress reduction, emotion regulation, improved mood and well being. Though, the studies have shown the beneficial effect of Yoga in improving the cognitive functions, no study till date has been studied to understand the role of Yoga in Vascular Dementia. The study will evaluate the effect of yoga on cognitive functions, self reported Dementia, the activity of daily living, and heart rate variability in Vascular dementia patients who are undergoing conventional therapy. This study is a randomized controlled trial, where we will compare two groups, case group - yoga intervention integrated with conventional treatment and control group. There will be 52 participants in each group diagnosed with vascular dementia by the specialist. Assessments of variables will be done at baseline and completion of 8 weeks. The intervention will be given for 8 weeks to all the participants in the case group.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
55.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Diagnosed case of Vascular Dementia as per DSM V.
  • •2.Age above 55 – 75 years 3.Zubrods performance status 1-2.

Exclusion Criteria

  • •1.Dementia due to any other etiology 2.History of recent /past Head Injury resulting in neurologic deficits 3.History of Neurosurgery-Craniotomy 4.History of Substance Dependence other than Nicotine 5.Those with prior h/o depression, a major psychiatric illness associated with cognitive illness 6.Those with brain metastases 7.Concurrent medical condition likely to influence survival 8.Uncontrolled diabetes, hypertension, and autoimmune disease 9.Neurological disorders such as any significant head injury, epilepsy, Parkinson’s disease, neurodegenerative disorders, etc.
  • •10.Regular participation in an active behavioral intervention/yoga in the last six months 11.H/o recent brain infections or fever in the past two months (meningitis/encephalitis) 12.Those with anemia (Hemoglobin < 10gm %) 13.LVEF<40% 14.H/o recent atrial fibrillation.

Outcomes

Primary Outcomes

Cognitive Functions

Time Frame: Before and after 2 months

Secondary Outcomes

  • Heart Rate Variability(Before and after 2 months)
  • Activities of Daily living(Before and after 2 months)
  • Self-reported Depression(Before and after 2 months)

Investigators

Sponsor
Central Council for Research in Yoga and Naturopathy Ministry of AYUSH
Sponsor Class
Government funding agency

Study Sites (1)

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