The Impact of Yoga Supplementation on Cognitive Function Among Indian Outpatients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 主要终点
- Cognitive assessment
研究概览
简要总结
Cognitive impairment is a key disabling feature of SZ. The impairment affects functional outcome and employability, resulting in increased burden. Currently, medications offer only modest benefits for the cognitive dysfunction. Hence, non-pharmacological interventions are worth consideration. Yoga is known to enhance cognitive abilities in healthy persons. Our preliminary studies have shown for the first time that there may be remarkable improvement in selected cognitive domains among outpatients with SZ. The improvement is unlikely to be due to rater bias, as they were noted using a computerized neurocognitive battery. Since our preliminary studies involved an open trial, it is necessary to conduct more controlled studies. To evaluate our results further, we propose to test the effectiveness of yoga supplementation using a controlled single blind design in India. Outpatients with SZ (N=258) undergoing treatment at a large academic center in New Delhi, India will be randomly assigned to one of the three groups- yoga training (YT, N=86), physical exercise (PE, N=86) or treatment as usual (TAU, N=86). The YT group will undergo 21 days yoga supplementation, while the PE group will complete a 21 day systematic physical exercise training regime. The third group will have no such supplementation. Cognitive state, symptom severity and overall function will be assessed at four time points: just before, immediately after, three months later and six months after completion of YT/PE supplementation. The evaluations will be conducted by raters blind to group status.
Hypotheses:
- Yoga enhances attention, as well as related cognitive function among persons with schizophrenia.
- Yoga has beneficial effects on the short term functional outcome of schizophrenia
详细描述
Cognitive impairment is a hallmark of schizophrenia (SZ). It affects the outcome of the disorder and markedly increases its burden. Various biological and psychological approaches are being tested to enhance cognitive capacity of these individuals, but the beneficial effects are modest. Yoga, the ancient Indian science of physical and mental fitness, offers a holistic approach to healthy life style and cognitive enhancement. Many studies have shown benefits of yoga for healthy individuals, and a few for psychiatric disorders. Despite its wide popularity, there are only a limited number of randomized, controlled yoga studies using objective quantitative outcome measures. Our preliminary studies have shown significant and substantial improvement in several domains of cognitive functioning among outpatients with SZ, using a simplified regimen in an open design. It is not clear if the benefits are due to physical activity alone or the entire yoga process per se. We propose to evaluate these results further, using a systematic random assignment design.
Explanatory model: The practice of yoga emphasizes body awareness and involves focusing one's attention on breathing or specific muscles or parts of body. We propose that the beneficial effects of yoga therapy (YT) observed in our preliminary studies relates to improvement in attention that extends to other cognitive domains.
Hypotheses:
- Yoga enhances attention, as well as related cognitive function among persons with schizophrenia.
- Yoga has beneficial effects on the short term functional outcome of schizophrenia.
Design: A systematic, single blind randomly assigned supplementation of routine outpatient training with yoga, compared with standard physical exercise and treatment as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM IV diagnosis of SZ
- •Age 18 years or greater
- •Residents of Delhi (to facilitate regular attendance and avoid dropouts)
排除标准
- •Residence outside Delhi
- •Prior participation in our Yoga studies (see preliminary studies section)
- •Mental retardation sufficient to impact understanding of YT
- •Substance or alcohol dependence for last six months which interferes with diagnosis
- •Presence of co-morbid conditions which may worsen with exercises (eg, recent myocardial infarction, fractures)
- •Presence of neurological illnesses such as strokes or head injury that may cause cognitive impairment independent of SZ, or complicates diagnosis/evaluation e.g. epilepsy, stroke
- •Presence of any physical disability or illness which makes the patient unfit for yoga or physical exercise
研究组 & 干预措施
Yoga Training Group
Yoga Training: Participants will be imparted yoga training for twenty-one days, for one hour a day. This will include postures or Asanas (exercises) and Pranayam (Breathing protocols).
干预措施: Yoga Training (Behavioral)
Physical Exercise Group
Physical Exercise: This group will take part in a general physical exercise program incorporating simple physical exercises for one hour daily, including Saturdays. The schedule will include fifteen minutes of brisk walking followed by light exercises.
干预措施: Physical Exercise (Behavioral)
Treatment as Usual Group
Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Cognitive assessment
时间窗: Changes in cognition from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed.
The key assessment will be based on an efficient, validated computerized battery called the Computerized Neurocognitive Battery (CNB) {Gur, 2001 #38} {Gur, 2001} . The assessment will be supplemented by the Information subscale of Post-graduate Institute Battery of Brain Dysfunction (PGI) (as an indirect assessment of intelligence) {Pershad, 1990} and the Trail Making Test {Horton, 1979}, a pen and paper measure of working memory.
次要结局
- Symptom assessment General Functioning(Changes in symptoms from baseline to 21 days intervention, three months and after six months after completing intervention will be assessed.)
研究者
Dr Triptish Bhatia
Research Consultant
Dr. Ram Manohar Lohia Hospital