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Yoga: Effect on Attention in Aging & Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Yoga

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with MS who are mildly impaired with an expanded disability status scale of 0-4.0 Healthy volunteers

Sites / Locations

  • Oregon Health Sciences University/Neurology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00010998
Brief Title
Yoga: Effect on Attention in Aging & Multiple Sclerosis
Official Title
Yoga: Effect on Attention in Aging & Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
Changes in visual attention are common among elders and people with multiple sclerosis. The visual attention changes contribute to difficulty with day to day functioning including falls, driving and even finding one's keys on the kitchen counter as well as contributing to deficits in other cognitive domains. Yoga emphasizes the ability to focus attention and there is some evidence that the practice of yoga may improve one's cognitive abilities. Additionally, yoga practice may improve cognitive function through other non-specific means such as improved mood, decreased stress or declines in oxidative injury. We propose a randomized, controlled 6 month phase II trial of yoga in two separate cohorts: healthy elders and subjects with mild multiple sclerosis. We will determine if yoga intervention produces improvements on a broad attentional battery that especially emphasizes attentional control. To further understand the reported beneficial effect of yoga on its practitioners, we will also determine if there is a positive impact on measures directly related to yoga practice (flexibility and balance) as well as mood, quality of life and oxidative injury markers. The yoga intervention consists of a Hatha yoga class meeting twice per week. The class is taught by experienced yoga teachers who are supervised by a nationally known yoga instructor. There are two control groups. An exercise group will have a structured walking program prescribed by a certified Health and Fitness Instructor and Personal Trainer. The program will attempt to match the Hatha yoga class for metabolic demand. The second control group will be assigned to a 6 month waiting list. The outcome measures are assessed at baseline and after the 6 month period. The primary outcome measures are alertness (quantitative EEG and self-rated scale), ability to focus attention (Stroop) and ability to shift attention (extradimensional set shifting task). Secondary attention outcome measures include the ability to sustain attention (decrement in reaction time) and ability to divide attention (Useful Field of View). Other secondary outcome measures include flexibility, balance, mood, quality of life, fatigue (in MS cohort) and decreased markers of lipid, protein, and DNA oxidative injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Yoga

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with MS who are mildly impaired with an expanded disability status scale of 0-4.0 Healthy volunteers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Barry S. Oken
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Sciences University/Neurology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

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Yoga: Effect on Attention in Aging & Multiple Sclerosis

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