Stretching and Yoga Exercise Study - Full Text View

Purpose

The investigators propose to test the effects of an 8-week supervised, site-based, group yoga intervention on cognition and functional fitness in older adults. The SAY Exercise study will compare the yoga group to a stretching group to determine if the program improves attention and cognition, reduces functional limitations, enhances functional performance in everyday activities, as well as psychological health in sedentary older adults between 55-80 years of age. The investigators also propose to assess heart rate variability using a 3-lead EKG and salivary cortisol levels to understand the moderators of the yoga-cognition relationship.

Condition	Intervention	Phase
Aging	Behavioral: Yoga Condition Behavioral: Stretching Condition	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	The Effects of an 8-Week Yoga Intervention on Cognition and Functional Fitness in Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of Illinois at Urbana-Champaign:

Primary Outcome Measures:

Changes in cognition as assessed by a neuropsychological battery of computer based and paper pencil tests from baseline to 8 weeks [ Time Frame: Baseline - 8 week ] [ Designated as safety issue: No ]
Participants will complete a neuropsychological battery of tasks assessing memory, attention, decision making at baseline (before beginning the program) and at week 8 (after completing the exercise program).

Secondary Outcome Measures:

Change in functional fitness from baseline to 8 weeks [ Time Frame: Baseline - 8 week ] [ Designated as safety issue: No ]
Participants will complete a battery of physical function tests assessing balance, flexibility, strength and mobility at baseline and week 8.
Change in psychosocial outcomes from baseline to 8 weeks [ Time Frame: Baseline - 8 week ] [ Designated as safety issue: No ]
Participants will complete a packet of questionnaires assessing self-esteem, postitive and negative affect including anxiety and depression, self-efficacy and other psychosocial outcomes.
Change in salivary cortisol from baseline to 8 weeks [ Time Frame: Baseline - week 8 ] [ Designated as safety issue: No ]
Participants will be providing a small saliva sample via a passive drool into a vial. The compound of interest is cortisol (an indicator of body stress).
Change in heart rate variability from baseline to 8-weeks [ Time Frame: Baseline - 8 week ] [ Designated as safety issue: No ]
The EKG for each participant will also be recorded in response to a 5 minute unpaced (normal) breathing and 5-minute paced (set to a metronome) breathing. All participants will complete these assessments at baseline and week 8.

Estimated Enrollment:	80
Study Start Date:	May 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Yoga Condition Participants will be instructed to learn yoga postures as well as yoga based breathing and meditative practices by certified yoga instructors. Primary Hatha yoga postures will be performed using props like yoga mats, blocks, belts and blankets. Classes will be held 3 times a week for 8 weeks.	Behavioral: Yoga Condition Classes lasting one hour, held 3 times per week for 8 weeks.
Active Comparator: Stretching Condition Exercises focusing on stretching and strengthening for all muscle groups will be performed at one-hour long sessions held 3 times a week for 8 weeks. Classes are led by trained exercise specialists.	Behavioral: Stretching Condition Classes lasting one hour, held 3 times per week for 8 weeks.

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

55-80 yrs of age
Low active: zero to two days of physical activity (>30 minutes per day) per week, in previous six months
Personal physicians consent to participate in testing and exercise intervention
Not involved in any other physical activity/exercise research study or cognitive training study.
Adequate responses to the Telephone interview of Cognitive Status (TICS-M) questionnaire
Corrected (near and far) acuity of 20/40 or better in both eyes
Initial depression score on GDS-15 below clinical levels (>5)
Able to get up and down from the floor
Comfortable with reading, writing and speaking English

Exclusion Criteria:

Below 55 or over 80 years of age
High physical activity levels (more than 2 times per week, >30 minutes, in the last 6 months)
Regular yoga practitioners (previously or currently practicing for more than 6 months)
Involved in other physical activity/exercise research study or cognitive training study
Non-consent of the physician
Inadequate response on the GDS-15 and TICS-M
Uncorrected (near and far) acuity of greater than 20/40 in either eye
Inability to communicate effectively in English
Intent to be away from the area for a long period of time resulting in more than 2 absences at the exercise sessions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650532

Locations

United States, Illinois
University of Illinois at Urbana Champaign
Urbana, Illinois, United States, 61801

Sponsors and Collaborators

University of Illinois at Urbana-Champaign

Investigators

Principal Investigator:

Edward McAuley, PhD

University of Illinois

More Information

No publications provided

Responsible Party:	Eddie McAuley, Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:	NCT01650532 History of Changes
Other Study ID Numbers:	UIUC_IRB_12362
Study First Received:	July 12, 2012
Last Updated:	February 1, 2013
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 13, 2013

Stretching and Yoga Exercise Study (SAYExercise)