NCT04323163

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

March 18, 2020

Last Update Submit

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

EXPERIMENTAL

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

Aerobic Group

EXPERIMENTAL

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

Stretching Toning Group

ACTIVE COMPARATOR

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

Interventions

3 sessions per week, 60 minutes per session for 6 months

Aerobic GroupStretching Toning GroupYoga Group

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

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.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Neha P Gothe, MA, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

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.

Locations