NCT04977804

Brief Summary

The study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
2.7 years until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

July 20, 2021

Last Update Submit

November 30, 2023

Conditions

Keywords

resistance trainingmuscle functionquadricepseccentric strengthvertical jumpmuscle qualitymuscle hypertrophyeccentric training

Outcome Measures

Primary Outcomes (4)

  • Eccentron maximal muscle strength

    Eccentric muscle strength will be assessed via Eccentron (BTE Technologies, Inc., USA), an seated isokinetic dynamometer.

    7 weeks

  • Local muscle hypertrophy

    Muscle size changes of the quadriceps muscle measured an ultrasound device (GE NextGen LOGIQ, Tampa, Florida, USA).

    7 weeks

  • Muscle mass

    dual energy x-ray absorptiometry device (DEXA) the Hologic Horizon W Dual X-ray absorptiometry (Hologic Canada ULC, Mississauga, ON, Canada) will be used to assess appendicular (lower body) mean mass.

    7 weeks

  • Muscle function

    Vertical jump height will assess 3 maximal countermovement attempts on a jump mat (Just Jump Technologies, Huntsville, AL, USA) that measures jump height based on flight time.

    7 weeks

Secondary Outcomes (1)

  • Muscle soreness

    7 weeks

Study Arms (2)

Eccentric only training

ACTIVE COMPARATOR

This is the experimental control; where this group will be used as the standard active comparison condition.

Other: Exercise

Eccentric plus blood-flow restriction

EXPERIMENTAL

This is the experimental condition involving the eccentric resistance training with blood flow restriction.

Other: Eccentric plus blood-flow restriction

Interventions

Eccentric plus blood-flow restriction

Eccentric plus blood-flow restriction

The interventions are a form or exercise, specifically resistance exercise.

Eccentric only training

Eligibility Criteria

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

You may qualify if:

  • years of age
  • currently engaged in some form of resistance training between 1-3 times per week
  • must have been training aerobically, but no more than 3 hours a week for the past six months

You may not qualify if:

  • Must not have had any surgery of the lower limbs within the past 1 year period
  • Must not have any neuromuscular disorder (e.g., Muscular dystrophy etc.)
  • \< 76 inches tall (in order to fit on the training machine)
  • Maximal strength of \< 725 lbs for the eccentric training device
  • If any of the subjects are pregnant or plan to be pregnant in the duration of the protocol.
  • For those randomized to the BFR group, if any of the subject's thighs are too large for the BFR cuffs (greater than 68 cm).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State Universtiy

Logan, Utah, 84322, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Brennan J Thompson, PhD

    Utah State Univeristy

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person assessing the outcome measures will be blinded to the group designation of the subjects.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two group, randomized parallel group design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 27, 2021

Study Start

March 30, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

December 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations