NCT05468255

Brief Summary

The purpose of this study is to determine if an acute bout of removal of exercise reduces enothelial function and glycemic control in an active, older adult population; and whether a 3 day return to exercise restores this response. Glycemic control is the blood glucose response following the consumption of a meal. It is an indicator of insulin resistance (or type 2 diabetes) and impaired glycemic control has been suggested to lead to cardiovascular disease. Endothelial function has been shown to be improved by chronic or acute increases in physical activity. Both of these have been shown to be impaired to acute bouts of inactivity in young populations; however the impact of acute inactivity in older adults is less understood. In this proposal the investigators will examine 1)how quickly impairments in glycemic control occur to acute physical inactivity in older adults who exercise, 2) how quickly impairments in endothelial function occur to acute inactivity in older adults who exercise, and 3) whether 3 days of a return to exercise restores these responses.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

May 9, 2022

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Continuous glucose monitoring

    3 days before removal of exercise

  • Continuous glucose monitoring

    After removal of exercise for 5 days

  • Continuous glucose monitoring

    After return to exercise for 3 days

  • Flow mediated dilation

    This measure assess blood vessel health non-invasively

    3 days before removal of exercise

  • Flow mediated dilation (vascular health)

    This measure assess blood vessel health non-invasively

    After removal of exercise for 5 days

  • Flow mediated dilation (vascular health)

    This measure assess blood vessel health non-invasively

    After return to exercise for 3 days

Study Arms (2)

Metabolic

EXPERIMENTAL

Metabolic: Participants will have their blood glucose levels measured via continuous glucose monitoring for 3 days while participating in their normal exercise routines (EX). Participants will also have their blood glucose levels measured for 3 days while not exercising (NOEX), following immediately by 3 days of a return to normal activity(REX). Participants will be randomized to participate in the EX or NOEX/REX phases first. The EX and NOEX/REX phases will be separated by at least 1 week

Other: removal of exercise

Vascular

EXPERIMENTAL

Vascular: Participants will have their blood vessel health measured while performing their normal exercise routines (EX) and while undergoing 1, 3, 5 days of no exercise (NOEX) followed immediately by 1 and 3 days of return to exercise (REX).

Other: removal of exercise

Interventions

Subjects will stop doing their normal exercise routines for 3 or 5 days and then subjects will resume doing their normal exercise routines for 3 days.

Also known as: return to exercise
MetabolicVascular

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years and older, 18-40 years old
  • Healthy, physically active, performing at least 90 min/week of physical activity
  • Free of physical limitations that may interfere with alterations in daily physical activity levels

You may not qualify if:

  • Physician diagnosed HIV, hepatitis, or tuberculosis.
  • Body weight change of greater than 5% within the previous 2 months
  • Smoking within the previous 2 months.
  • Taking medications that alter blood glucose levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Old Dominion University

Norfolk, Virginia, 23529, United States

RECRUITING

MeSH Terms

Conditions

Glucose IntoleranceMotor Activity

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Central Study Contacts

Leryn Reynolds

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 9, 2022

First Posted

July 21, 2022

Study Start

July 25, 2022

Primary Completion

January 30, 2025

Study Completion

April 1, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations