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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02659007
Other study ID # 14-4894H
Secondary ID
Status Completed
Phase Phase 1
First received January 14, 2016
Last updated January 15, 2016
Start date September 2014
Est. completion date August 2015

Study information

Verified date January 2016
Source Colorado State University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
yoga
8 weeks of yoga, twice a week. sitting, standing, and floor postures with meditation and breath work

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Colorado State University

Outcome

Type Measure Description Time frame Safety issue
Primary change in Neuro-QoL used to assess health related quality of life in people with neuro disability baseline and 8 weeks No
Primary change in Berg balance Scale assess static and dynamic balance baseline and 8 weeks No
Primary change in 6 minute walk amount of feet walked in 6 minutes, used to assess endurance baseline and 8 weeks No
Primary change in 10 meter walk amount of time to walk 10 meters, measures gait speed baseline and 8 weeks No
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