NCT05344391

Brief Summary

This study will investigate if subjects who bike at 40% of heart rate reserve (HRR) with blood flow restriction (BFR) applied to bilateral thighs for 10 minutes (at 80% limb occlusion pressure) will experience greater gains in 10 rep max for dominant lower extremity leg press, greater gains in rotator cuff strength (hand held dynamometer testing for supraspinatus and external rotators) and greater gains in VO2 peak.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

April 10, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

April 19, 2022

Last Update Submit

April 22, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • VO2peak

    Pretest/posttest measures of VO2peak performance on the bicycle using Cosmed Metabolic Cart

    6 weeks

  • Shoulder Strength

    Using a Hand Held Dynamometer; shoulder strength will be measured pretest/posttest for teh supraspinatus and the shoulder external rotators (dominant UE)

    6 weeks

  • 10 RM unilateral leg press for the dominant lower extremity

    Test 10 RM strength on the leg press for the dominant LE/ pretest/posttest

    6 weeks

Study Arms (2)

BFR cycling

EXPERIMENTAL

This group will perform cycling with BFR applied bilaterally at 80% LOP for 10 min and cycling at 40% HRR. Next they will perform 3x15 of the scaption and sidelying external rotation exercises. These will initially be performed at 30% 1RM; every 2 weeks load increased by 1lbs.

Other: BFR cycling

Cycling without BFR

ACTIVE COMPARATOR

This group will perform cycling and the same shoulder exercises using the same training parameters; however, BFR will not be applied.

Other: Cycling without BFR

Interventions

Cycling with BFR followed by shoulder exercises

BFR cycling

Cycling without BFR followed by shoulder exercises

Cycling without BFR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

College of Physical Therapy / George Fox University

Newberg, Oregon, 97132, United States

RECRUITING

George Fox University School of Physical Therapy

Newberg, Oregon, 97132, United States

RECRUITING

Study Officials

  • JASON BRUMITT, PhD

    George Fox University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JASON BRUMITT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

April 10, 2022

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations