- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010998
Yoga: Effect on Attention in Aging & Multiple Sclerosis
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97201
- Oregon Health Sciences University/Neurology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with MS who are mildly impaired with an expanded disability status scale of 0-4.0
- Healthy volunteers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr. Barry S. Oken, Oregon Health and Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Study Completion
December 1, 2004
Study Registration Dates
First Submitted
February 2, 2001
First Submitted That Met QC Criteria
February 2, 2001
First Posted (Estimate)
February 5, 2001
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P50AT000066-01P3 (U.S. NIH Grant/Contract)
- P50AT000066-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.