NCT05131217

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

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

November 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

November 11, 2021

Last Update Submit

November 28, 2023

Conditions

Keywords

MCAvWorking MemoryCognitionExercise IntensityCerebral Blood FlowHIIT

Outcome Measures

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

Secondary Outcomes (3)

  • Working Memory

    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

  • Internal Carotid Artery (ICA) Diameter

    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

  • Internal Carotid Artery (ICA) Pulse Velocity

    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

Other Outcomes (6)

  • Heart Rate

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

  • End Tidal CO2 (ETCO2)

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

  • Mean Arterial Pressure (MAP)

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

  • +3 more other outcomes

Study Arms (3)

Acute bout of Continuous Moderate Intensity Exercise

EXPERIMENTAL
Other: Acute bout of Continuous Moderate Intensity Exercise

Acute bout of High Intensity Interval Training (HIIT)

EXPERIMENTAL
Other: Acute bout of High Intensity Interval Training

Control

EXPERIMENTAL
Other: Control

Interventions

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 Continuous Moderate Intensity Exercise

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.

Also known as: HIIT
Acute bout of High Intensity Interval Training (HIIT)
ControlOTHER

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.

Also known as: Rest
Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • + 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia; Kinesiology Labs

Charlottesville, Virginia, 22903, United States

Location

Related Publications (35)

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MeSH Terms

Interventions

RE1-silencing transcription factor

Study Officials

  • Jason Allen, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The individual analyzing study data will be blind to subject allocation.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Exercise Physiology at the University of Virginia, Director of the Exercise Physiology Graduate Program & Co-Director of the Applied Metabolism & Physiology Lab

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 23, 2021

Study Start

January 14, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations