Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 3:57 AM
Study NCT ID:
NCT01650532
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stretching and Yoga Exercise Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2012-07-12', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in cognition as assessed by a neuropsychological battery of computer based and paper pencil tests from baseline to 8 weeks', 'timeFrame': 'Baseline - 8 week', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in functional fitness from baseline to 8 weeks', 'timeFrame': 'Baseline - 8 week', 'description': 'Participants will complete a battery of physical function tests assessing balance, flexibility, strength and mobility at baseline and week 8.'}, {'measure': 'Change in psychosocial outcomes from baseline to 8 weeks', 'timeFrame': 'Baseline - 8 week', 'description': 'Participants will complete a packet of questionnaires assessing self-esteem, postitive and negative affect including anxiety and depression, self-efficacy and other psychosocial outcomes.'}, {'measure': 'Change in salivary cortisol from baseline to 8 weeks', 'timeFrame': 'Baseline - week 8', 'description': '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).'}, {'measure': 'Change in heart rate variability from baseline to 8-weeks', 'timeFrame': 'Baseline - 8 week', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '27794449', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '26297940', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 55-80 yrs of age\n* Low active: zero to two days of physical activity (\\>30 minutes per day) per week, in previous six months\n* Personal physicians consent to participate in testing and exercise intervention\n* Not involved in any other physical activity/exercise research study or cognitive training study.\n* Adequate responses to the Telephone interview of Cognitive Status (TICS-M) questionnaire\n* Corrected (near and far) acuity of 20/40 or better in both eyes\n* Initial depression score on GDS-15 below clinical levels (\\>5)\n* Able to get up and down from the floor\n* Comfortable with reading, writing and speaking English\n\nExclusion Criteria:\n\n* Below 55 or over 80 years of age\n* High physical activity levels (more than 2 times per week, \\>30 minutes, in the last 6 months)\n* Regular yoga practitioners (previously or currently practicing for more than 6 months)\n* Involved in other physical activity/exercise research study or cognitive training study\n* Non-consent of the physician\n* Inadequate response on the GDS-15 and TICS-M\n* Uncorrected (near and far) acuity of greater than 20/40 in either eye\n* Inability to communicate effectively in English\n* Intent to be away from the area for a long period of time resulting in more than 2 absences at the exercise sessions'}, 'identificationModule': {'nctId': 'NCT01650532', 'acronym': 'SAYExercise', 'briefTitle': 'Stretching and Yoga Exercise Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'The Effects of an 8-Week Yoga Intervention on Cognition and Functional Fitness in Older Adults', 'orgStudyIdInfo': {'id': 'UIUC_IRB_12362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga Condition', 'description': '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.', 'interventionNames': ['Behavioral: Yoga Condition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching Condition', 'description': '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.', 'interventionNames': ['Behavioral: Stretching Condition']}], 'interventions': [{'name': 'Yoga Condition', 'type': 'BEHAVIORAL', 'description': 'Classes lasting one hour, held 3 times per week for 8 weeks.', 'armGroupLabels': ['Yoga Condition']}, {'name': 'Stretching Condition', 'type': 'BEHAVIORAL', 'description': 'Classes lasting one hour, held 3 times per week for 8 weeks.', 'armGroupLabels': ['Stretching Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Urbana Champaign', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'overallOfficials': [{'name': 'Edward McAuley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Edward McAuley', 'investigatorAffiliation': 'University of Illinois at Urbana-Champaign'}}}}