NCT05309603

Brief Summary

The purpose of this study is to determine change in injury risk and performance variables in males and females after walking unloaded and carrying a load with two different distributions (high-pack placement and mid-pack placement) to identify differences in injury risk

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 21, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

March 24, 2022

Last Update Submit

August 15, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Oxygen Consumption

    Oxygen consumption will be measured using indirect calorimetry

    Upon completion of 3 miles of walking, an average of 45 minutes

  • Increased muscular jerk

    Jerk will be measured using accelerometers placed at the torso and ankle

    Upon completion of 3 miles of walking, an average of 45 minutes

Study Arms (3)

Unloaded Walking

ACTIVE COMPARATOR

Walking on a treadmill without wearing a pack

Other: Walking

Loaded Walking High

EXPERIMENTAL

Walking on a treadmill while wearing a 30% body mass load with the weight placed at the high-back

Other: Loaded Walking High

Loaded Walking Mid

EXPERIMENTAL

Walking on a treadmill while wearing a 30% body mass load with the weight placed at the mid-back

Other: Loaded Walking Mid

Interventions

Walking three miles on a treadmill at a self-selected speed while wearing a backpack with weight carried high on the back

Loaded Walking High

Walking three miles on a treadmill at a self-selected speed while wearing a backpack with weight carried on the mid-back

Loaded Walking Mid
WalkingOTHER

Walking three miles on a treadmill at a self-selected speed

Unloaded Walking

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, physically active individuals
  • years old

You may not qualify if:

  • History of musculoskeletal injury within the last six months or still under a physicians care for an injury occurring more than six month prior
  • History of spinal disc injury
  • History of cardiovascular, metabolic, respiratory, neural, or renal disease
  • No previous history or education of completing resistance exercise
  • Hypertensive or tachycardic during the screening visit (SBP \> 139 mmHg, DBP \> 89 mmHg, heart rate \> 100 bpm)
  • Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., beta blockers, omega-3 fatty acids, statins, aspirin)
  • Any form of tobacco or nicotine use
  • A positive pregnancy test at any point in the study
  • Study physician discretion based on any other medical condition or medication
  • Gastrointestinal disease or previous surgery prohibiting internal body temperature pill use. Subjects who have any contraindication to internal body temperature pill ingestion will be given the option to insert the pill rectally (as a suppository) or use a rectal probe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Motor ActivityFatigue

Interventions

Walking

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Riana Pryor, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 4, 2022

Study Start

March 21, 2022

Primary Completion

July 21, 2023

Study Completion

July 21, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

We do not plan to share IPD with other researchers.

Locations