NCT01650532

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

July 12, 2012

Last Update Submit

February 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in cognition as assessed by a neuropsychological battery of computer based and paper pencil tests from baseline to 8 weeks

    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).

    Baseline - 8 week

Secondary Outcomes (4)

  • Change in functional fitness from baseline to 8 weeks

    Baseline - 8 week

  • Change in psychosocial outcomes from baseline to 8 weeks

    Baseline - 8 week

  • Change in salivary cortisol from baseline to 8 weeks

    Baseline - week 8

  • Change in heart rate variability from baseline to 8-weeks

    Baseline - 8 week

Study Arms (2)

Yoga Condition

EXPERIMENTAL

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

Stretching Condition

ACTIVE COMPARATOR

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

Interventions

Yoga ConditionBEHAVIORAL

Classes lasting one hour, held 3 times per week for 8 weeks.

Yoga Condition

Classes lasting one hour, held 3 times per week for 8 weeks.

Stretching Condition

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (2)

  • Gothe NP, Keswani RK, McAuley E. Yoga practice improves executive function by attenuating stress levels. Biol Psychol. 2016 Dec;121(Pt A):109-116. doi: 10.1016/j.biopsycho.2016.10.010. Epub 2016 Oct 26.

  • Gothe NP, McAuley E. Yoga Is as Good as Stretching-Strengthening Exercises in Improving Functional Fitness Outcomes: Results From a Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2016 Mar;71(3):406-11. doi: 10.1093/gerona/glv127. Epub 2015 Aug 22.

Study Officials

  • Edward McAuley, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 26, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations