NCT02659007

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

January 14, 2016

Last Update Submit

January 15, 2016

Conditions

Diabetic Neuropathy

Keywords

yogabalance

Outcome Measures

Primary Outcomes (4)

  • change in Neuro-QoL

    used to assess health related quality of life in people with neuro disability

    baseline and 8 weeks

  • change in Berg balance Scale

    assess static and dynamic balance

    baseline and 8 weeks

  • change in 6 minute walk

    amount of feet walked in 6 minutes, used to assess endurance

    baseline and 8 weeks

  • change in 10 meter walk

    amount of time to walk 10 meters, measures gait speed

    baseline and 8 weeks

Study Arms (1)

yoga

EXPERIMENTAL

yoga, 2 times a week for 8 weeks

Other: yoga

Interventions

yogaOTHER

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

yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Yoga

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 20, 2016

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share