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Yoga Training for Returning Veterans With Headache

Primary Purpose

Post Traumatic Headache, Chronic Daily Headache

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iyengar-based Yoga Training
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Headache

Eligibility Criteria

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

Inclusion Criteria:

Eligibility determined at screening will be based on the following inclusion criteria: Mild post traumatic headaches or chronic tension-type headaches, diagnosed by a physician. Inclusion criteria also includes the following: 1). Ability to participate in yoga classes (i.e., no physical limitations, mobility issues, or severe chronic medical issues/symptoms such as severe chronic back pain or injury, amputees, being wheelchair bound), 2). Not current involved in regular yoga of more than an hour of yoga per week in a formal setting, 3). If a woman, not currently pregnant or breast feeding, 4). Ages 18 and up (no maximal age limit), 5). Veterans only (no non-veteran populations), and 6). Not currently suffering from severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder), a history of psychiatric hospitalization, or current substance abuse or dependence.

Exclusion Criteria:

Exclusion based on the following: 1). Age less than 18 years old (not an adult); 2). Not a veteran; 3). Physical limitations, mobility issues, or severe chronic medical issues that may impede one's ability to participate in yoga classes (e.g., wheelchair bound veterans, amputees, those with severe musculoskeletal or nerve pain or injury such as chronic back pain with significantly limited range of motion); 4). Current severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder) or history of psychiatric hospitalizations; 5). Current substance abuse or dependence; 6). Current regular yoga practice involving more than an hour of yoga per week in a formal setting; and 7). If a woman, currently pregnant or breast feeding.

Sites / Locations

  • VA Greater Los Angeles Healthcare System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iyengar-based Yoga Training

Arm Description

6 weekly Iyengar-based yoga classes

Outcomes

Primary Outcome Measures

Symptom relief, headache

Secondary Outcome Measures

Full Information

First Posted
July 16, 2013
Last Updated
May 1, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01993069
Brief Title
Yoga Training for Returning Veterans With Headache
Official Title
Yoga Training for Returning Veterans With Headache
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with mild post-traumatic and chronic tension-type headaches. Study Aims: Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tension-type headaches experience, assist in decreasing headaches and associated symptoms? Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tensions-type headaches experience, assist in improving quality of life? Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tension-type headaches experience, improve mood? Do the effects of yoga on symptoms, mood, and quality of life maintain 2 months post completion of treatment?
Detailed Description
The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with mild post-traumatic and chronic tension-type headaches. The yoga will be provided in the form of 6 weekly yoga sessions aimed at providing direct instruction and immediate feedback on postures, breathing, and relaxation techniques in a small group format. The sessions will be led by an experienced yoga instructor who is a part of the study team and have worked with medical patients. A post-yoga 2-month follow-up assessment of self-reported symptoms, mood, and quality of life will also be assessed. This is a feasibility study to determine if a yoga treatment is received favorably and can be successfully delivered to veterans seeking treatments for post-traumatic and chronic tension-type headaches. This study does not include a comparison group; therefore, we can only make conclusions based on pre to post differences in subjects who participate in the yoga. Our aim for this study is to collect data on the potential benefits of a targeted yoga treatment for symptoms experienced by these subjects, and to then utilize these data to implement a larger study with a comparison group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Headache, Chronic Daily Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iyengar-based Yoga Training
Arm Type
Experimental
Arm Description
6 weekly Iyengar-based yoga classes
Intervention Type
Behavioral
Intervention Name(s)
Iyengar-based Yoga Training
Intervention Description
6 weekly Iyengar-based yoga classes
Primary Outcome Measure Information:
Title
Symptom relief, headache
Time Frame
Post-Treatment, up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligibility determined at screening will be based on the following inclusion criteria: Mild post traumatic headaches or chronic tension-type headaches, diagnosed by a physician. Inclusion criteria also includes the following: 1). Ability to participate in yoga classes (i.e., no physical limitations, mobility issues, or severe chronic medical issues/symptoms such as severe chronic back pain or injury, amputees, being wheelchair bound), 2). Not current involved in regular yoga of more than an hour of yoga per week in a formal setting, 3). If a woman, not currently pregnant or breast feeding, 4). Ages 18 and up (no maximal age limit), 5). Veterans only (no non-veteran populations), and 6). Not currently suffering from severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder), a history of psychiatric hospitalization, or current substance abuse or dependence. Exclusion Criteria: Exclusion based on the following: 1). Age less than 18 years old (not an adult); 2). Not a veteran; 3). Physical limitations, mobility issues, or severe chronic medical issues that may impede one's ability to participate in yoga classes (e.g., wheelchair bound veterans, amputees, those with severe musculoskeletal or nerve pain or injury such as chronic back pain with significantly limited range of motion); 4). Current severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder) or history of psychiatric hospitalizations; 5). Current substance abuse or dependence; 6). Current regular yoga practice involving more than an hour of yoga per week in a formal setting; and 7). If a woman, currently pregnant or breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Naliboff, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Milena Zirovich, MD
Organizational Affiliation
VAGLAHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

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Yoga Training for Returning Veterans With Headache

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