Stretching and Yoga Exercise Study (SAYExercise)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edward McAuley, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01650532
First received: July 12, 2012
Last updated: October 18, 2013
Last verified: October 2013
  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:


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.


Enrollment: 118
Study Start Date: May 2012
Study Completion Date: March 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 at Chicago
  More Information

No publications provided

Responsible Party: Edward 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: October 18, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014