Yoga as a Complementary Therapy for Adults With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: YogaBehavioral: Standard Exercise Program
- Registration Number
- NCT02607566
- Lead Sponsor
- The Miriam Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Type 2 diabetes for more than 6 months
- HbA1c > 6.5
- Body Mass Index < 42
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iyengar Yoga Yoga Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks. Standard Exercise Program Standard Exercise Program 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
- Primary Outcome Measures
Name Time Method Acceptability as measured by session attendance 12 weeks Number of sessions attended
Feasibility as measured by study completion 6 months Percent of enrolled subjects completing all assessments
- Secondary Outcome Measures
Name Time Method Changes in diabetes-related distress as measured by Diabetes Related Distress Survey Baseline to Week 12 Percent change in score on the Diabetes Related Distress Survey (Polonsky et al., 1995)
Changes in Salivary Cortisol (ug/dL) between baseline and week 12 Baseline to Week 12 Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL)
HbA1c 6 months HbA1c levels from blood draws
Diabetes Self-Care 12 weeks Surveys of diabetes related self care activities
Trial Locations
- Locations (2)
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
The Miriam Hospital- CORO building
🇺🇸Providence, Rhode Island, United States