AzTrials
AzTrials

Aging WellNCT05131217

Effects of Acute Exercise Intensity on Cerebral Blood Flow and Cognitive Function in Older Adults

A study testing Acute bout of Continuous Moderate Intensity Exercise and Acute bout of High Intensity Interval Training in people with Aging Well, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will analyze the influence of acute bout exercise intensities (continuous moderate and HIIT) on middle cerebral artery velocity (MCAv) to identify which intensity elicits the greatest increase in CBF in older adults (65+ yrs). Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Aging Well
What is being tested?
Acute bout of Continuous Moderate Intensity Exercise and Acute bout of High Intensity Interval Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
14 Jan 2022to 1 May 2023
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65+ years of age
  • Comfortable with experiencing exercise-induced fatigue
  • Willingness and ability to comply with scheduled visits and study procedures
  • Able to provide consent on their own behalf
  • Type 2 Diabetics accepted

Who cannot join

  • Competitive athlete (Recreationally active is okay but no more than 3 days/week of structured exercise)
  • VO2max below 18 ml/kg/min in men, 15ml/kg/min in women (minimum thresholds for independent living seniors)
  • Inability of study staff to acquire signal from the MCA using TCD
  • Diagnosis of mild cognitive impairment, Parkinson's Disease, Alzheimer's Disease, multiple sclerosis, or psychiatric illness (unless mild depression or anxiety)
  • History of brain damage/stroke/concussions
  • Cardiovascular Disease, Pulmonary Disease, or dependence of supplemental O2
Show all 11Show fewer
  • Type 2 Diabetics who aren't cleared by the study physician during the first screening visit (HbA1C > 8.5%)
  • Neuromuscular or musculoskeletal dysfunctions impairing one from cycling
  • Changes in vasoactive medication dose or quantity, recently prior to or during the study time course, or inability to maintain regular timed ingestion of vasoactive medication
  • Currently involved in Estrogen or Testosterone Replacement Therapy
  • Unable to abstain from food consumption (3hrs), caffeine/alcohol consumption (12hrs), and vigorous exercise (24hrs) prior to experimental procedures

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Virginia; Kinesiology Labs

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

This study will analyze the influence of acute bout exercise intensities (continuous moderate and HIIT) on middle cerebral artery velocity (MCAv) to identify which intensity elicits the greatest increase in CBF in older adults (65+ yrs). Additionally, this study will help verify positive correlations between MCAv and cognitive function. These findings are important in determining the optimal exercise prescription for increased resilience against the age-related cognitive degradation.

Read the detailed description

With an increasingly aging population, it is paramount that we further understand the changes that occur during aging, especially those which contribute to cognitive decline. Evidence shows that cognitive function is closely linked to brain blood flow. When comparing cerebral blood flow (CBF) between old and young individuals, older adults appear to have lower baseline levels of CBF. One of the principle determinants of CBF is CO2. Since exercise results in rises in CO2 production, changes in CBF can be monitored. Older adults appear to have diminished changes in CBF compared to younger individuals during moderate intensity exercise. This then leads to the idea that older adults may need a greater exercise stimulus (i.e. HIIT) to see these changes in CBF. However, the effects of HIIT on CBF in older adults is largely unstudied.

Purpose: To analyze the acute influence of HIIT on middle cerebral artery velocity (MCAv) in older adults, and to verify the positive association between MCAv and cognitive function.

Experimental Design: Recruiting 16 healthy adults age 65 and older. The study will require each participant to report to 4 visits: a screening visit, a control, a moderate intensity exercise bout, and a high intensity exercise bout. The order of the experimental visits will be randomized to each subject, and exercise bouts will be work-matched. During the experimental visits, MCAv, end-tidal CO2, MAP, and HR will be measured continuously. Vascular measures such as pulse wave analysis and pulse wave velocity will be taken pre- and post-exercise. Additionally, blood flow through the internal carotid artery and cognitive measures (n-back test) will be measured and administered pre-exercise, and at 15 mins, 30 mins, and 45 mins post-exercise. A two-way repeated measures ANOVA will be used to determine significant differences for time (pre vs. post measures) x condition (control/moderate/HIIT).

Results: In the process of collecting data.

Implications: If the study is successful in its findings, this could change how exercise is prescribed to older adults. It could also lead to the question regarding if a greater exercise stimulus (i.e. SIT) may be even more beneficial for these individuals.

Conditions
Aging Well
Being tested
Acute bout of Continuous Moderate Intensity Exercise, Acute bout of High Intensity Interval Training, Control
Keywords
MCAv, Working Memory, Cognition, Exercise Intensity, Cerebral Blood Flow, HIIT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute bout of Continuous Moderate Intensity ExerciseOther

    In this experimental intervention subjects will cycle continuously at moderate intensity (VO2 corresponding to lactate threshold) until a 200 kcal equivalent energy expenditure is reached.

  • Acute bout of High Intensity Interval TrainingOther

    Also called HIIT

    In this experimental invention subjects will alternate between 1 minute of high intensity cycling (watts corresponding to 85% VO2peak) and 1 minute of low intensity cycling (watts corresponding to 35-40% VO2peak) until a 200 kcal equivalent energy expenditure is reached.

  • ControlOther

    Also called Rest

    In this intervention placebo, subjects will lay down on a flat, soft surface for 30 minutes in a dimly light room. They will not be allowed to use any electronic devices or read during this time to avoid potentially influencing continuous data recording.

Study groups in NCT05131217
Study groupRoleWhat they receive
Acute bout of Continuous Moderate Intensity ExerciseExperimentalNot described
Receives: Other: Acute bout of Continuous Moderate Intensity Exercise
Acute bout of High Intensity Interval Training (HIIT)ExperimentalNot described
Receives: Other: Acute bout of High Intensity Interval Training
ControlExperimentalNot described
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Middle Cerebral Artery Velocity (MCAv)

    Blood flow velocity measured in the Middle Cerebral Artery via Transcranial Doppler probe secured to the right temporal window.

    Measured: Measured continuously over the course of each experimental session (i.e. 2-3 hours)

Secondary outcomes (3)
  1. Working Memory

    Measured via n-back test (2-back); Subject's will be presented a sequence of letters (25 of them from a base set of 15 letters) one-by-one and will have 3 seconds to indicate whether the letter they see currently matches the letter from 2 frames ago. If there is no match, then they do not need to respond.They will complete three rounds each with a different sequence. Accuracy score (%) = correct inputs/# of stimuli, averaged across 3 blocks.

    Measured: 4 individual measurements taken during each experimental session with each session lasting up to about 3 hours. 1 pre-intervention measurement and 3 post-intervention measurements spaced at least 15min apart

  2. Internal Carotid Artery (ICA) Diameter

    Measured via Ultrasound; diameter will be measured as the peak of the pulse wave

    Measured: 4 individual measurements taken during each experimental session with each session lasting up to about 3 hours. 1 pre-intervention measurement and 3 post-intervention measurements spaced at least 15min apart

  3. Internal Carotid Artery (ICA) Pulse Velocity

    Measured via Ultrasound; velocity will be assessed at the peak of each pulse wave

    Measured: 4 individual measurements taken during each experimental session with each session lasting up to about 3 hours. 1 pre-intervention measurement and 3 post-intervention measurements spaced at least 15min apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start14 Jan 2022
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

Resources

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
Crossover
Model description
This is a repeated measures cross-over design, in which all subjects will complete all acute exercise intensity conditions: HIIT, continuous moderate intensity at lactate threshold (LT), and rest (control). The order of the acute treatment bouts will be randomized for each subject over three experimental visits (not counting the screening visit).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05131217
Sponsor's protocol ID
HSR200454
Status last verified
Nov 2023
First submitted
11 Nov 2021
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thudium M, Heinze I, Ellerkmann RK, Hilbert T. Cerebral Function and Perfusion during Cardiopulmonary Bypass: A Plea for a Multimodal Monitoring Approach. Heart Surg Forum. 2018 Jan 31;21(1):E028-E035. doi: 10.1532/hsf.1894.

    PubMed 29485961
  • Shoemaker LN, Wilson LC, Lucas SJE, Machado L, Thomas KN, Cotter JD. Swimming-related effects on cerebrovascular and cognitive function. Physiol Rep. 2019 Oct;7(20):e14247. doi: 10.14814/phy2.14247.

    PubMed 31637867
  • Alexandrov AV, Sloan MA, Wong LK, Douville C, Razumovsky AY, Koroshetz WJ, Kaps M, Tegeler CH; American Society of Neuroimaging Practice Guidelines Committee. Practice standards for transcranial Doppler ultrasound: part I--test performance. J Neuroimaging. 2007 Jan;17(1):11-8. doi: 10.1111/j.1552-6569.2006.00088.x.

    PubMed 17238867
  • Burley CV, Francis ST, Whittaker AC, Mullinger KJ, Lucas SJE. Measuring resting cerebral haemodynamics using MRI arterial spin labelling and transcranial Doppler ultrasound: Comparison in younger and older adults. Brain Behav. 2021 Jul;11(7):e02126. doi: 10.1002/brb3.2126. Epub 2021 May 25.

    PubMed 34032379
  • Fan JL, Nogueira RC, Brassard P, Rickards CA, Page M, Nasr N, Tzeng YC. Integrative physiological assessment of cerebral hemodynamics and metabolism in acute ischemic stroke. J Cereb Blood Flow Metab. 2022 Mar;42(3):454-470. doi: 10.1177/0271678X211033732. Epub 2021 Jul 26.

    PubMed 34304623
  • Klein T, Sanders M, Wollseiffen P, Carnahan H, Abeln V, Askew CD, Claassen JA, Schneider S. Transient cerebral blood flow responses during microgravity. Life Sci Space Res (Amst). 2020 May;25:66-71. doi: 10.1016/j.lssr.2020.03.003. Epub 2020 Mar 19.

    PubMed 32414494
  • Loe H, Rognmo O, Saltin B, Wisloff U. Aerobic capacity reference data in 3816 healthy men and women 20-90 years. PLoS One. 2013 May 15;8(5):e64319. doi: 10.1371/journal.pone.0064319. Print 2013.

    PubMed 23691196
  • Ogoh S, Ainslie PN. Cerebral blood flow during exercise: mechanisms of regulation. J Appl Physiol (1985). 2009 Nov;107(5):1370-80. doi: 10.1152/japplphysiol.00573.2009. Epub 2009 Sep 3.

    PubMed 19729591
  • Settakis G, Lengyel A, Molnar C, Bereczki D, Csiba L, Fulesdi B. Transcranial Doppler study of the cerebral hemodynamic changes during breath-holding and hyperventilation tests. J Neuroimaging. 2002 Jul;12(3):252-8.

    PubMed 12116744
  • Shephard RJ. Maximal oxygen intake and independence in old age. Br J Sports Med. 2009 May;43(5):342-6. doi: 10.1136/bjsm.2007.044800. Epub 2008 Apr 10.

    PubMed 18403414
  • Jones-Muhammad M, Warrington JP. Redefining the cerebral autoregulatory range of blood pressures: Not as wide as previously reported. Physiol Rep. 2021 Sep;9(17):e15006. doi: 10.14814/phy2.15006.

    PubMed 34435458
  • Keating CJ, Parraga Montilla JA, Latorre Roman PA, Moreno Del Castillo R. Comparison of High-Intensity Interval Training to Moderate-Intensity Continuous Training in Older Adults: A Systematic Review. J Aging Phys Act. 2020 Apr 16;28(5):798-807. doi: 10.1123/japa.2019-0111. Print 2020 Oct 1.

    PubMed 32303000
  • Smith KJ, Ainslie PN. Regulation of cerebral blood flow and metabolism during exercise. Exp Physiol. 2017 Nov 1;102(11):1356-1371. doi: 10.1113/EP086249. Epub 2017 Sep 30.

    PubMed 28786150
  • Calverley TA, Ogoh S, Marley CJ, Steggall M, Marchi N, Brassard P, Lucas SJE, Cotter JD, Roig M, Ainslie PN, Wisloff U, Bailey DM. HIITing the brain with exercise: mechanisms, consequences and practical recommendations. J Physiol. 2020 Jul;598(13):2513-2530. doi: 10.1113/JP275021. Epub 2020 Jun 1.

    PubMed 32347544
  • Ogoh S, Tsukamoto H, Hirasawa A, Hasegawa H, Hirose N, Hashimoto T. The effect of changes in cerebral blood flow on cognitive function during exercise. Physiol Rep. 2014 Sep 28;2(9):e12163. doi: 10.14814/phy2.12163. Print 2014 Sep 1.

    PubMed 25263210

Questions about this trial

What is this clinical trial studying?

A study testing Acute bout of Continuous Moderate Intensity Exercise and Acute bout of High Intensity Interval Training in people with Aging Well, run by University of Virginia 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 5 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 29 Nov 2023. 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?

Middle Cerebral Artery Velocity (MCAv) (time frame: Measured continuously over the course of each experimental session (i.e. 2-3 hours)). 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 NCT05131217, which also lists 35 linked publications.

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 29 Nov 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in