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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00010998
Other study ID # P50 AT000066-01P3
Secondary ID P50AT000066-01
Status Completed
Phase Phase 2
First received February 2, 2001
Last updated August 17, 2006
Start date September 1999
Est. completion date December 2004

Study information

Verified date August 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT00009503

Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients with MS who are mildly impaired with an expanded disability status scale of 0-4.0

- Healthy volunteers

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Yoga


Locations

Country Name City State
United States Oregon Health Sciences University/Neurology Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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