NCT07052227

Brief Summary

This study will investigate the use of different blood flow restriction cuffs during leg press exercise on arterial stiffness, muscle morphology, performance, and participant perception.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 26, 2025

Last Update Submit

June 26, 2025

Conditions

Delfi CuffFitcuffPlacebo - Control

Outcome Measures

Primary Outcomes (1)

  • Pulse wave velocity

    10 minutes before and 10 minutes after the exercise intervention

Study Arms (3)

Delfi

EXPERIMENTAL
Device: Delfi blood flow restriction cuff

Fitcuff

EXPERIMENTAL
Device: Fitcuffs

Control

PLACEBO COMPARATOR
Other: Control

Interventions

Delfi blood flow restriction cuffDEVICE

Leg press exercise with Delfi blood flow restriction cuff

Delfi
FitcuffsDEVICE

Leg press exercise with Fitcuff blood flow restriction cuff

Fitcuff
ControlOTHER

Leg press exercise with no blood flow restriction cuff

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active (\> 1,000 MET/min/wk) for at least six months.
  • Weight stable for previous 6 months (+/-2.5 kg)

You may not qualify if:

  • Stage 2 hypertension (SBP \>/= 140 and/or DBP \>/= 90 mmHg)
  • BMI\>40 kg/m2
  • Diabetes
  • Familial hypercholesterolemia
  • Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
  • Participants must not be pregnant, plan to become pregnant during the study, or be nursing
  • Active renal or liver disease
  • All medications and supplements that influence dependent variables\*
  • Recent surgery \< 2 months
  • Alcohol abuse
  • Sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salisbury University

Salisbury, Maryland, 21801, United States

Location

Central Study Contacts

Tim Werner, PhD

CONTACT

410-548-3526tjwerner@salisbury.edu

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
Professor

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

September 1, 2025

Primary Completion

December 14, 2025

Study Completion

December 15, 2025

Last Updated

July 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Excel spreadsheet with data will be shared upon request.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

US(1)