ClinicalTrials.gov
ClinicalTrials.gov Menu

Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga (LeNY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02659007
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Arlene Schmid, Colorado State University

Brief Summary:
The long-term goal is to identify and establish effective mind-body interventions (as an aspect of complementary and alternative medicine) to improve health and Quality of Life (QoL) for people with disabilities. Preliminary data suggest that engagement in yoga is feasible and beneficial for multiple study populations, and it may relieve symptoms of neuropathy. The central hypothesis is that individuals who complete yoga will have significantly better balance, mobility, and QoL after 8 weeks of yoga.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Other: yoga Phase 1

Detailed Description:
assessments completed before and after yoga. yoga was delivered twice a week for 8 weeks for one hour each session. Yoga included sitting, standing, and floor postures, breath work, and meditation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Less Neuropathy After Yoga
Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: yoga
yoga, 2 times a week for 8 weeks
Other: yoga
8 weeks of yoga, twice a week. sitting, standing, and floor postures with meditation and breath work




Primary Outcome Measures :
  1. change in Neuro-QoL [ Time Frame: baseline and 8 weeks ]
    used to assess health related quality of life in people with neuro disability

  2. change in Berg balance Scale [ Time Frame: baseline and 8 weeks ]
    assess static and dynamic balance

  3. change in 6 minute walk [ Time Frame: baseline and 8 weeks ]
    amount of feet walked in 6 minutes, used to assess endurance

  4. change in 10 meter walk [ Time Frame: baseline and 8 weeks ]
    amount of time to walk 10 meters, measures gait speed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anyone age 18 and over with DPN from Diabetes Mellitus and a balance impairment. and be able and willing to attend twice weekly sessions for 8 weeks.

Exclusion Criteria:

  • not have consistently engaged in yoga for greater than a year.

Responsible Party: Arlene Schmid, Associate Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT02659007     History of Changes
Other Study ID Numbers: 14-4894H
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arlene Schmid, Colorado State University:
yoga
balance

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases