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临床试验/NCT02607566
NCT02607566已完成不适用

Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation

The Miriam Hospital4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
4
主要终点
Acceptability as measured by session attendance

研究概览

简要总结

This study will examine the feasibility and acceptability of a twice weekly yoga program for adults with type 2 diabetes. Changes in perceived stress, salivary cortisol, and HbA1c will also be examined.

详细描述

The purpose of the current proposal is to test a yoga intervention for adults with T2DM and to gather data on the feasibility and acceptability of yoga compared to a contact control for glycemic control. The investigators will conduct a pilot randomized controlled study with participants randomly assigned to 1) Yoga intervention, or 2) A standard exercise (SE) group program (comparison-control). Focus groups will be conducted with participants at the end of the intervention to identify facilitators and barriers to yoga practice and to examine their perceptions and beliefs about yoga and its relationship to stress and diabetes management. The investigators will explore the effect of yoga on stress (biomarker = salivary cortisol) that may act as a mechanism of action underlying the efficacy of yoga for improved glycemic control. The investigators will also measure HbA1c levels, fasting and postprandial plasma glucose at baseline, end of treatment (12-weeks), 6- and 9-month follow-ups. Study feasibility and acceptability will be assessed using participant recruitment, attendance and retention rates, and compliance with study protocols and satisfaction with the program. Participants will also attend a focus-group discussion of the program at the end of treatment. Results from this study will provide scientific basis for a future larger clinical trial. Yoga, if found to offer advantages for glycemic control, can have potential for high impact on current practices of diabetes management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes for more than 6 months
  • HbA1c > 6.5
  • Body Mass Index < 42

排除标准

  • Serious co-morbid condition (e.g. uncontrolled hypertension, glaucoma, heart failure)
  • Complications of diabetes (e.g. diabetic retinopathy, neuropathy, nephropathy)
  • Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence)
  • Body Mass Index of 42 or greater
  • Pregnancy or planned pregnancy

研究组 & 干预措施

Iyengar Yoga

Experimental

Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks.

干预措施: Yoga (Behavioral)

Standard Exercise Program

Active Comparator

professionally supervised program of aerobic exercise including use of an indoor walking track, treadmills, stationary bicycles and elliptical machines, held for 60 minutes twice weekly for 12 weeks

干预措施: Standard Exercise Program (Behavioral)

结局指标

主要结局

Acceptability as measured by session attendance

时间窗: 12 weeks

Number of sessions attended

Feasibility as measured by study completion

时间窗: 6 months

Percent of enrolled subjects completing all assessments

次要结局

  • Changes in diabetes-related distress as measured by Diabetes Related Distress Survey(Baseline to Week 12)
  • Changes in Salivary Cortisol (ug/dL) between baseline and week 12(Baseline to Week 12)
  • HbA1c(6 months)
  • Diabetes Self-Care(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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