AgingNCT04323163
Yoga, Aerobic and Stretching Exercise Effects on Neurocognition
A study testing Physical Activity in people with Aging and Cognitive Decline, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Decline
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: 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
- Conditions
- Aging, Cognitive Decline
- Being tested
- Physical Activity
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
3 sessions per week, 60 minutes per session for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (2)
Change in brain structure
MRI will be used to measure brain volume.
Measured: Baseline, 6 months, 12 months
Change in brain function
Functional MRI will be used to measure changes in brain activity during resting state.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start6 Jan 2021
- Primary completion31 Aug 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Principal investigator, Neha P. Gothe, University of Illinois at Urbana-Champaign
- Investigators
- Neha P Gothe, MA, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323163
- Sponsor's protocol ID
- 20714
- Status last verified
- Jul 2024
- First submitted
- 18 Mar 2020
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37244365
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga, Aerobic and Stretching Exercise Effects on Neurocognitive Performance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04323163
- Acronym / sponsor ID
- 20714
- Conditions
- Aging, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Behavioral: Physical ActivityParticipants 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 | Experimental | Behavioral: Physical ActivityTrained 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 comparator | Behavioral: Physical ActivityParticipants 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. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity3 sessions per week, 60 minutes per session for 6 months | Behavioural | Aerobic Group, Stretching Toning Group, Yoga Group |
Primary outcome
Change in cognitive function
Time frame: Baseline, 6 months, 12 months
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.
2 secondary outcomes
Change in brain structure
Time frame: Baseline, 6 months, 12 months
Change in brain function
Time frame: Baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 37244365Gothe 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha P Gothe, MA, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Aging and Cognitive Decline, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04323163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.