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Yoga as a Complementary Therapy for Adults With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Standard Exercise Program
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Yoga, Walking, Stress, exercise, glycemic control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Miriam Hospital- CORO building
  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iyengar Yoga

Standard Exercise Program

Arm Description

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

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

Outcomes

Primary Outcome Measures

Acceptability as measured by session attendance
Number of sessions attended
Feasibility as measured by study completion
Percent of enrolled subjects completing all assessments

Secondary Outcome Measures

Changes in diabetes-related distress as measured by Diabetes Related Distress Survey
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
Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL)
HbA1c
HbA1c levels from blood draws
Diabetes Self-Care
Surveys of diabetes related self care activities

Full Information

First Posted
November 12, 2015
Last Updated
April 23, 2019
Sponsor
The Miriam Hospital
Collaborators
University of Massachusetts, Lowell, Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02607566
Brief Title
Yoga as a Complementary Therapy for Adults With Type 2 Diabetes
Official Title
Yoga as a Complementary Therapy for Type 2 Diabetes: An Initial Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
University of Massachusetts, Lowell, Rhode Island Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, Yoga, Walking, Stress, exercise, glycemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iyengar Yoga
Arm Type
Experimental
Arm Description
Iyengar Yoga Intervention twice weekly for 60 minutes for 12 weeks.
Arm Title
Standard Exercise Program
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Type
Behavioral
Intervention Name(s)
Standard Exercise Program
Intervention Description
twice weekly aerobic exercise program, 60 minutes for 12 weeks
Primary Outcome Measure Information:
Title
Acceptability as measured by session attendance
Description
Number of sessions attended
Time Frame
12 weeks
Title
Feasibility as measured by study completion
Description
Percent of enrolled subjects completing all assessments
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in diabetes-related distress as measured by Diabetes Related Distress Survey
Description
Percent change in score on the Diabetes Related Distress Survey (Polonsky et al., 1995)
Time Frame
Baseline to Week 12
Title
Changes in Salivary Cortisol (ug/dL) between baseline and week 12
Description
Saliva samples collected at baseline and week 12 will be assayed for cortisol levels (ug/dL)
Time Frame
Baseline to Week 12
Title
HbA1c
Description
HbA1c levels from blood draws
Time Frame
6 months
Title
Diabetes Self-Care
Description
Surveys of diabetes related self care activities
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes for more than 6 months HbA1c > 6.5 Body Mass Index < 42 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Bock, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital- CORO building
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30130144
Citation
Thind H, Fava JL, Guthrie KM, Stroud L, Gopalakrishnan G, Sillice M, Gidron N, Bock BC. Yoga as a Complementary Therapy for Adults with Type 2 Diabetes: Design and Rationale of the Healthy, Active, and in Control (HA1C) Study. Int J Yoga Therap. 2018 Nov;28(1):123-132. doi: 10.17761/2018-00026. Epub 2018 Aug 21.
Results Reference
background
PubMed Identifier
30712714
Citation
Thind H, Guthrie KM, Horowitz S, Conrad M, Bock BC. "I can do almost anything": The experience of adults with type 2 diabetes with a yoga intervention. Complement Ther Clin Pract. 2019 Feb;34:116-122. doi: 10.1016/j.ctcp.2018.11.011. Epub 2018 Nov 16. No abstract available.
Results Reference
result
PubMed Identifier
30670230
Citation
Bock BC, Thind H, Fava JL, Dunsiger S, Guthrie KM, Stroud L, Gopalakrishnan G, Sillice M, Wu W. Feasibility of yoga as a complementary therapy for patients with type 2 diabetes: The Healthy Active and in Control (HA1C) study. Complement Ther Med. 2019 Feb;42:125-131. doi: 10.1016/j.ctim.2018.09.019. Epub 2018 Sep 26.
Results Reference
result
PubMed Identifier
28882745
Citation
Thind H, Lantini R, Balletto BL, Donahue ML, Salmoirago-Blotcher E, Bock BC, Scott-Sheldon LAJ. The effects of yoga among adults with type 2 diabetes: A systematic review and meta-analysis. Prev Med. 2017 Dec;105:116-126. doi: 10.1016/j.ypmed.2017.08.017. Epub 2017 Sep 4.
Results Reference
result

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Yoga as a Complementary Therapy for Adults With Type 2 Diabetes

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