Yoga, Aerobic and Stretching Exercise Effects on Neurocognition

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323163
• Other study ID #: 20714
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: Neha P Gothe, MA, PhD
• Phone: 217.300.6183
• Email: npg[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• Physical Activity
3 sessions per week, 60 minutes per session for 6 months

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Change in brain structure	MRI will be used to measure brain volume.	Baseline, 6 months, 12 months
Secondary	Change in brain function	Functional MRI will be used to measure changes in brain activity during resting state.	Baseline, 6 months, 12 months