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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01650532
Other study ID # UIUC_IRB_12362
Secondary ID
Status Completed
Phase N/A
First received July 12, 2012
Last updated February 21, 2017
Start date May 2012
Est. completion date March 2013

Study information

Verified date February 2017
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga Condition
Classes lasting one hour, held 3 times per week for 8 weeks.
Stretching Condition
Classes lasting one hour, held 3 times per week for 8 weeks.

Locations

Country Name City State
United States University of Illinois at Urbana Champaign Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in functional fitness from baseline to 8 weeks Participants will complete a battery of physical function tests assessing balance, flexibility, strength and mobility at baseline and week 8. Baseline - 8 week
Secondary Change in psychosocial outcomes from baseline to 8 weeks 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
Secondary Change in salivary cortisol from baseline to 8 weeks 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
Secondary Change in heart rate variability from baseline to 8-weeks 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
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