AgingSAYExerciseNCT01650532
Stretching and Yoga Exercise Study
A study testing Yoga Condition and Stretching Condition in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Yoga Condition and Stretching Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana Champaign
Urbana, Illinois, 61801
About this study
Official title: 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.
- Conditions
- Aging
- Being tested
- Yoga Condition, Stretching Condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ConditionBehavioural
Classes lasting one hour, held 3 times per week for 8 weeks.
Stretching ConditionBehavioural
Classes lasting one hour, held 3 times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Condition | Experimental | 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. Receives: Behavioral: Yoga Condition |
| Stretching Condition | Active comparator | 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. Receives: Behavioral: Stretching Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline - 8 week
Secondary outcomes (4)
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.
Measured: Baseline - 8 week
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.
Measured: Baseline - 8 week
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).
Measured: Baseline - week 8
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.
Measured: Baseline - 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward McAuley, University of Illinois at Urbana-Champaign
- Investigators
- Edward McAuley, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650532
- Sponsor's protocol ID
- UIUC_IRB_12362
- Acronym
- SAYExercise
- Status last verified
- Feb 2017
- First submitted
- 12 Jul 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27794449Gothe 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.
PubMed 26297940
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an 8-Week Yoga Intervention on Cognition and Functional Fitness in Older Adults
- ClinicalTrials.gov ID
- NCT01650532
- Acronym / sponsor ID
- SAYExercise / UIUC_IRB_12362
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Condition | Experimental | Behavioral: Yoga ConditionParticipants 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. |
| Stretching Condition | Active comparator | Behavioral: Stretching ConditionExercises 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga ConditionClasses lasting one hour, held 3 times per week for 8 weeks. | Behavioural | Yoga Condition |
| Stretching ConditionClasses lasting one hour, held 3 times per week for 8 weeks. | Behavioural | Stretching Condition |
Primary outcome
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).
4 secondary outcomes
Change in functional fitness from baseline to 8 weeks
Time frame: Baseline - 8 week
Change in psychosocial outcomes from baseline to 8 weeks
Time frame: Baseline - 8 week
Change in salivary cortisol from baseline to 8 weeks
Time frame: Baseline - week 8
Change in heart rate variability from baseline to 8-weeks
Time frame: Baseline - 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 27794449Gothe 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.
- Derived from this study: PubMed 26297940Gothe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward McAuley, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Condition and Stretching Condition in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.