Yoga, Aerobic and Stretching Exercise Effects on Neurocognition

Yoga, Aerobic and Stretching Exercise Effects on Neurocognitive Performance: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Aging; Cognitive Decline
• Intervention / Treatment: Behavioral: Physical Activity

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neha P Gothe, MA, PhD; Phone Number: 217.300.6183; Email: npg@illinois.edu
• Study Contact Backup: Name: Rae M McDonald, MA; Phone Number: 217.265.0741; Email: rmmcdnl2@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois at Urbana-Champaign
      • Contact: Rae M McDonald, MA; Email: rmmcdnl2@illinois.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain structure	MRI will be used to measure brain volume.	Baseline, 6 months, 12 months
Change in brain function	Functional MRI will be used to measure changes in brain activity during resting state.	Baseline, 6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in physiological biomarkers	Brain-derived neurotrophic factor (BDNF) will be assessed through a blood serum analysis at each timepoint.	Baseline, 6 months, 12 months
Changes in cardiovascular fitness	The mediating role of cardiorespiratory fitness will be assessed by using a treadmill based graded exercise test designed to measure peak VO2 capacity	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: Wayne State University
• Investigators: Principal Investigator: Neha P Gothe, MA, PhD, University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 20714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No