Yoga, Aerobic and Stretching Exercise Effects on Neurocognition
1 other identifier
interventional
145
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedJuly 31, 2024
July 1, 2024
2.6 years
March 18, 2020
July 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in cognitive function
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.
Baseline, 6 months, 12 months
Secondary Outcomes (2)
Change in brain structure
Baseline, 6 months, 12 months
Change in brain function
Baseline, 6 months, 12 months
Other Outcomes (2)
Changes in physiological biomarkers
Baseline, 6 months, 12 months
Changes in cardiovascular fitness
Baseline, 6 months, 12 months
Study Arms (3)
Yoga Group
EXPERIMENTALParticipants 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.
Aerobic Group
EXPERIMENTALTrained 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.
Stretching Toning Group
ACTIVE COMPARATORParticipants 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.
Interventions
3 sessions per week, 60 minutes per session for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Urbana-Champaignlead
- Wayne State Universitycollaborator
Study Sites (1)
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801, United States
Related Publications (1)
Gothe NP, Erlenbach E, Garcia V, Malani R, Voss S, Camacho PB, McAuley E, Burd N, Sutton BP, Damoiseaux JS. Yoga, aerobic and stretching exercise effects on neurocognition: Randomized controlled trial protocol. Contemp Clin Trials. 2023 Aug;131:107240. doi: 10.1016/j.cct.2023.107240. Epub 2023 May 25.
PMID: 37244365DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neha P Gothe, MA, PhD
University of Illinois at Urbana-Champaign
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 18, 2020
First Posted
March 26, 2020
Study Start
January 6, 2021
Primary Completion
August 31, 2023
Study Completion
May 31, 2024
Last Updated
July 31, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
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.