NCT04249986

Brief Summary

Backpacking is an increasingly popular outdoor recreational activity. The base pack weight (BPW) includes gear that is not consumed or worn on the body: shelter, sleep system, weather-proofing layers and personal gear to ensure a degree of comfort and safety. As such, reducing BPW is one of the most important tasks a backpacker manages when preparing for a trip. Available recommendations for ideal BPW are currently inconsistent, lack clear parameters, and rely on anecdotal evidence. The study aims to collect field data on perceived exertion and heart rate (HR) in relation to BPW during a day-long interval of hiking. Such findings can have implications on the cost and safety profiles extending from recreational backpacking to military and wilderness rescue operations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

January 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

February 21, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

4.4 years

First QC Date

January 24, 2020

Last Update Submit

August 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Borg Rating of Perceived Exertion During the Total Hike

    Participants will report their perceived exertion towards the end of both hikes. The Borg Rating of Perceived Exertion scale ranges from 6 to 20. 6 being the lowest score of no exertion and 20 being the highest of maximal exertion.

    2 weeks

Secondary Outcomes (2)

  • Heart Rate

    2 weeks

  • The Borg Rating of Perceived Exertion During Incline and Decline Sections of the participant

    2 weeks

Study Arms (2)

The Borg Rating of Perceived Exertion between 17 and 19 lb BPW

ACTIVE COMPARATOR

Participants will be randomized to both 17 and 19 pounds for the first hike and the alternate condition for the second hike. A random number generator will create 1 block that includes 10 participants in each block to ensure comparable numbers to subjects starting at different base backpack weight. Participants assignments will then be included in a sealed manila envelopes.

Behavioral: The Borg Rating of Perceived Exertion

The Borg Rating of Perceived Exertion between 19 and 17 lb BPW

ACTIVE COMPARATOR

Participants will be randomized to both 19 or 17 pounds for the first hike and the alternate condition for the second hike. A random number generator will create 1 block that includes 10 participants in each block to ensure comparable numbers to subjects starting at different base backpack weight. Participants assignments will then be included in a sealed manila envelopes.

Behavioral: The Borg Rating of Perceived Exertion

Interventions

Participants who satisfy the exclusion criteria and health assessment instrument are categorized in the lowest risk group for cardiac events and does not require medical screening for mild to moderate exercise per ACSM guidelines.

The Borg Rating of Perceived Exertion between 17 and 19 lb BPWThe Borg Rating of Perceived Exertion between 19 and 17 lb BPW

Eligibility Criteria

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

You may qualify if:

  • Only adult (age 18-65)
  • Have gone on at least two overnight backpacking trips in the past 5 years
  • Have hiked at least 8 miles in a day on one of those trips

You may not qualify if:

  • Lower extremity injuries or surgeries in the past 6-months
  • Daily Smokers
  • Chronic medical problems:
  • Hypertension
  • High cholesterol
  • Diabetes
  • Heart attack
  • Heart surgery, cardiac catheterization, or coronary angioplasty
  • Pacemaker/implantable cardiac defibrillator/rhythm disturbance
  • Heart valve disease
  • Heart failure
  • Heart transplantation
  • Congenital heart disease
  • Kidney disease
  • Back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Fresno

Fresno, California, 93703, United States

Location

Study Officials

  • Susanne Spano, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 31, 2020

Study Start

February 21, 2020

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations