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Yoga, Aerobic and Stretching Exercise Effects on Neurocognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323163
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : November 22, 2021
Sponsor:
Collaborator:
Wayne State University
Information provided by (Responsible Party):
Neha P. Gothe, University of Illinois at Urbana-Champaign

Study Description
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Brief Summary:

The investigators propose to conduct a 6-month 3-arm randomized controlled exercise trial among older adults to compare the efficacy of yoga with aerobic exercise and stretching-toning exercises on cognitive function, brain structure and function, cardiorespiratory fitness, functional fitness, and inflammatory and molecular markers. Using a single-blind, three arm randomized control trial, 168 older adults ages 55-79 will be assigned to either: a Hatha yoga group, an aerobic exercise group or an active stretching and toning control group. The groups will engage in hour-long group exercise sessions 3x/week. A comprehensive neurocognitive test battery, brain imaging, cardiovascular fitness test, and a blood draw will take place at baseline; end of the 6-month intervention, and at 12-month follow-up.

The proposed work will examine the relationship between yoga training and improved cognitive functioning as well as identify neurobiological correlates as potential mechanisms of action through which yoga training exerts its effect on cognitive function.

COVID-19 Precautions: Due to COVID-19, all exercise sessions will be conducted live via Zoom video-conferencing such that 1/3rd of the participants in each group will exercise in person with the research staff at UIUC campus once a week while the remaining 2/3rd will tune in via Zoom


Condition or disease Intervention/treatment Phase
Aging Cognitive Decline Behavioral: Physical Activity Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Yoga, Aerobic and Stretching Exercise Effects on Neurocognitive Performance: A Randomized Controlled Trial
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Yoga Group
Participants will be led through a beginner yoga course taught by a certified yoga instructor. Classes will meet three times a week for 60 minutes over the 6 month study duration. Sessions will focus on yoga postures, breathing, and meditative practices and may utilize mats, blocks, belts, and blankets.
 Behavioral: Physical Activity
3 sessions per week, 60 minutes per session for 6 months
Experimental: Aerobic Group
Trained exercise instructors will lead participants through an aerobic group exercise class. Sessions will begin with a 15-20 minute aerobics class and increase in duration over the 6 months capping off at 40-minutes per session. The prescribed intensity will be 50-60% of the maximum heart rate reserve for weeks one to six and 60-75% for the remainder of the program.
 Behavioral: Physical Activity
3 sessions per week, 60 minutes per session for 6 months
Active Comparator: Stretching Toning Group
Participants randomized to this group will meet three times a week for an hour-long structured group exercise session. This group will perform stretching and toning exercises using resistance bands, balance disks, and exercise mats.
 Behavioral: Physical Activity
3 sessions per week, 60 minutes per session for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Change in cognitive function [ Time Frame: Baseline, 6 months, 12 months ]
    A comprehensive neuropsychological battery (part of the NIH toolbox) will be used that assesses different domains of cognitive function, including working memory, attention and executive function.


Secondary Outcome Measures :
  1. Change in brain structure [ Time Frame: Baseline, 6 months, 12 months ]
    MRI will be used to measure brain volume.

  2. Change in brain function [ Time Frame: Baseline, 6 months, 12 months ]
    Functional MRI will be used to measure changes in brain activity during resting state.


Other Outcome Measures:
  1. Changes in physiological biomarkers [ Time Frame: Baseline, 6 months, 12 months ]
    Brain-derived neurotrophic factor (BDNF) will be assessed through a blood serum analysis at each timepoint.

  2. Changes in cardiovascular fitness [ Time Frame: Baseline, 6 months, 12 months ]
    The mediating role of cardiorespiratory fitness will be assessed by using a treadmill based graded exercise test designed to measure peak VO2 capacity


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 55-79 years of age at study enrollment
  • TICS-M score of 32 or higher
  • No current or past diagnosis of mild cognitive impairment or dementias
  • Low-active (≤ 2 days of 30 minutes of structured exercise/week)
  • Physician's consent to participate in VO2max testing and the exercise program
  • Ambulatory
  • Absence of health conditions that may be exacerbated by exercise
  • Good or corrected vision and hearing
  • No MRI contraindications (e.g. metal or implanted devices in the body)
  • Right-handed
  • Intention to remain in the Champaign-Urbana area over the study duration

Exclusion Criteria:

  • Below 55 or above 79 years of age at study enrollment
  • TICS-M score of 31 or lower
  • Current or past diagnosis of mild cognitive impairment or dementias
  • High-active (3 or more days of 30 minutes of structured exercise/week)
  • Physician's non-consent to participate in VO2max testing and the exercise program
  • Non-ambulatory (use of wheelchairs or walkers)
  • Presence of health conditions that may be exacerbated by exercise
  • Poor vision and hearing
  • MRI contraindications (e.g. metal or implanted devices in the body)
  • Left-handed
  • Plans to travel outside of Champaign-Urbana area during the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323163


Contacts
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Contact: Neha P Gothe, MA, PhD 217.300.6183 npg@illinois.edu
Contact: Rae M McDonald, MA 217.265.0741 rmmcdnl2@illinois.edu

Locations
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United States, Illinois
University of Illinois at Urbana-Champaign Recruiting
Urbana, Illinois, United States, 61801
Contact: Rae M McDonald, MA       rmmcdnl2@illinois.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Wayne State University
Investigators
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Principal Investigator: Neha P Gothe, MA, PhD University of Illinois at Urbana-Champaign
More Information
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Responsible Party: Neha P. Gothe, Assistant Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT04323163    
Other Study ID Numbers: 20714
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Given the pilot nature of the study and limited study outcomes, we do not expect to receive requests from other researchers to analyze our datasets. The primary and secondary outcomes and exploratory biomarker data will be published by the Investigative team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders