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Stretching and Yoga Exercise Study (SAYExercise)

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ClinicalTrials.gov Identifier: NCT01650532
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Edward McAuley, University of Illinois at Urbana-Champaign

Tracking Information
First Submitted Date  ICMJE July 12, 2012
First Posted Date  ICMJE July 26, 2012
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stretching and Yoga Exercise Study
Official Title  ICMJE The Effects of an 8-Week Yoga Intervention on Cognition and Functional Fitness in Older Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Aging
Intervention  ICMJE
  • Behavioral: Yoga Condition
    Classes lasting one hour, held 3 times per week for 8 weeks.
  • Behavioral: Stretching Condition
    Classes lasting one hour, held 3 times per week for 8 weeks.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Yoga Condition
  • 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.
    Intervention: Behavioral: Stretching Condition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2013)
118
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2012)
80
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01650532
Other Study ID Numbers  ICMJE UIUC_IRB_12362
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edward McAuley, University of Illinois at Urbana-Champaign
Study Sponsor  ICMJE University of Illinois at Urbana-Champaign
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward McAuley, PhD University of Illinois at Chicago
PRS Account University of Illinois at Urbana-Champaign
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP