search
Back to results

Yoga, Aerobic and Stretching Exercise Effects on Neurocognition

Primary Purpose

Aging, Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois at Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Yoga Group

Aerobic Group

Stretching Toning Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in brain structure
MRI will be used to measure brain volume.
Change in brain function
Functional MRI will be used to measure changes in brain activity during resting state.

Full Information

First Posted
March 18, 2020
Last Updated
January 27, 2023
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Wayne State University
search

1. Study Identification

Unique Protocol Identification Number
NCT04323163
Brief Title
Yoga, Aerobic and Stretching Exercise Effects on Neurocognition
Official Title
Yoga, Aerobic and Stretching Exercise Effects on Neurocognitive Performance: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Cognitive Decline

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching Toning Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
3 sessions per week, 60 minutes per session for 6 months
Primary Outcome Measure Information:
Title
Change in cognitive function
Description
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.
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in brain structure
Description
MRI will be used to measure brain volume.
Time Frame
Baseline, 6 months, 12 months
Title
Change in brain function
Description
Functional MRI will be used to measure changes in brain activity during resting state.
Time Frame
Baseline, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Changes in physiological biomarkers
Description
Brain-derived neurotrophic factor (BDNF) will be assessed through a blood serum analysis at each timepoint.
Time Frame
Baseline, 6 months, 12 months
Title
Changes in cardiovascular fitness
Description
The mediating role of cardiorespiratory fitness will be assessed by using a treadmill based graded exercise test designed to measure peak VO2 capacity
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neha P Gothe, MA, PhD
Phone
217.300.6183
Email
npg@illinois.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rae M McDonald, MA
Phone
217.265.0741
Email
rmmcdnl2@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha P Gothe, MA, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rae M McDonald, MA
Email
rmmcdnl2@illinois.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Yoga, Aerobic and Stretching Exercise Effects on Neurocognition

We'll reach out to this number within 24 hrs