search
Back to results

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

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
yoga
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring yoga, balance

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    yoga

    Arm Description

    yoga, 2 times a week for 8 weeks

    Outcomes

    Primary Outcome Measures

    change in Neuro-QoL
    used to assess health related quality of life in people with neuro disability
    change in Berg balance Scale
    assess static and dynamic balance
    change in 6 minute walk
    amount of feet walked in 6 minutes, used to assess endurance
    change in 10 meter walk
    amount of time to walk 10 meters, measures gait speed

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2016
    Last Updated
    January 15, 2016
    Sponsor
    Colorado State University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02659007
    Brief Title
    Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga
    Acronym
    LeNY
    Official Title
    Less Neuropathy After Yoga
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Colorado State University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Neuropathy
    Keywords
    yoga, balance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    yoga
    Arm Type
    Experimental
    Arm Description
    yoga, 2 times a week for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    yoga
    Intervention Description
    8 weeks of yoga, twice a week. sitting, standing, and floor postures with meditation and breath work
    Primary Outcome Measure Information:
    Title
    change in Neuro-QoL
    Description
    used to assess health related quality of life in people with neuro disability
    Time Frame
    baseline and 8 weeks
    Title
    change in Berg balance Scale
    Description
    assess static and dynamic balance
    Time Frame
    baseline and 8 weeks
    Title
    change in 6 minute walk
    Description
    amount of feet walked in 6 minutes, used to assess endurance
    Time Frame
    baseline and 8 weeks
    Title
    change in 10 meter walk
    Description
    amount of time to walk 10 meters, measures gait speed
    Time Frame
    baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga

    We'll reach out to this number within 24 hrs