NCT05606744

Brief Summary

The purpose of this study is to compare the muscle strength and muscle soreness effects experienced following short term (acute) eccentric exercise with and without blood flow restriction (BFR) performed at low - moderate training intensities.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

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

October 13, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

October 13, 2022

Last Update Submit

November 3, 2022

Conditions

Outcome Measures

Primary Outcomes (10)

  • visual analog scale (soreness)

    soreness

    Baseline (pretest)

  • visual analog scale (soreness)

    soreness

    immediately post exercise

  • visual analog scale (soreness)

    soreness

    24 hours post exercise

  • visual analog scale (soreness)

    soreness

    48 hours post exercise

  • visual analog scale (soreness)

    soreness

    72 hours post exercise

  • force algometer (soreness)

    soreness

    Baseline (pretest)

  • force algometer (soreness)

    soreness

    immediately post exercise

  • force algometer (soreness)

    soreness

    24 hours post exercise

  • force algometer (soreness)

    soreness

    48 hours post exercise

  • force algometer (soreness)

    soreness

    72 hours post exercise

Secondary Outcomes (10)

  • Eccentric muscle strength

    Baseline (pretest)

  • Eccentric muscle strength

    immediately post exercise

  • Eccentric muscle strength

    24 hours post exercise

  • Eccentric muscle strength

    48 hours post exercise

  • Eccentric muscle strength

    72 hours post exercise

  • +5 more secondary outcomes

Study Arms (2)

Eccentric exercise

ACTIVE COMPARATOR

Only multi-joint eccentric exercise

Device: Eccentric exercise / Eccentric exercise with blood flow restriction

Eccentric training with blood flow restriction

EXPERIMENTAL

Multi-joint eccentric exercise with blood flow restriction

Device: Eccentric exercise / Eccentric exercise with blood flow restriction

Interventions

Individuals will be randomized to receive eccentric exercise only, or eccentric exercise with blood flow restriction.

Eccentric exerciseEccentric training with blood flow restriction

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • lower body surgery or injury in the last 12 months
  • have any neuromuscular disease
  • height \>76 inches tall
  • height \<54 inches tall
  • eccentric strength greater than 725 pounds
  • pregnant or plan to be pregnant in the duration of the protocol
  • don't do resistance exercise at least once per week
  • perform intense cardio or strength training \>4 days per week
  • Present with any other significant comorbid conditions that would impair the ability to participate in the exercise-based testing
  • years old
  • strength train lower body 1-3 times per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Brennan Thompson, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brennan J Thompson, PhD

CONTACT

Sara Harper, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Individuals will be randomly assigned to a BFR or non BFR exercise condition. The subjects will perform a single, 3-5 minute bout of eccentric exercise on the Eccentron device either with BFR (with restriction cuffs on the thigh per the procedures below) or without the BFR.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2022

First Posted

November 7, 2022

Study Start

June 1, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

November 7, 2022

Record last verified: 2022-11