Stretching and Yoga Exercise Study (SAYExercise)

February 21, 2017 updated by: Edward McAuley, University of Illinois at Urbana-Champaign

The Effects of an 8-Week Yoga Intervention on Cognition and Functional Fitness in Older Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

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

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

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

55 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional fitness from baseline to 8 weeks
Time Frame: Baseline - 8 week
Participants will complete a battery of physical function tests assessing balance, flexibility, strength and mobility at baseline and week 8.
Baseline - 8 week
Change in psychosocial outcomes from baseline to 8 weeks
Time Frame: Baseline - 8 week
Participants will complete a packet of questionnaires assessing self-esteem, postitive and negative affect including anxiety and depression, self-efficacy and other psychosocial outcomes.
Baseline - 8 week
Change in salivary cortisol from baseline to 8 weeks
Time Frame: Baseline - week 8
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).
Baseline - week 8
Change in heart rate variability from baseline to 8-weeks
Time Frame: Baseline - 8 week
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.
Baseline - 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: Edward McAuley, PhD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (ESTIMATE)

July 26, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • UIUC_IRB_12362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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