Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Backpack Weight Impacts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249986
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Exertion; Excess Behavioral: The Borg Rating of Perceived Exertion Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Backpack Weight Impacts on Perceived Exertion and Heart Rate Variability
Actual Study Start Date : February 21, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: The Borg Rating of Perceived Exertion between 17 and 19 lb BPW
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
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.

Active Comparator: The Borg Rating of Perceived Exertion between 19 and 17 lb BPW
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
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.




Primary Outcome Measures :
  1. The Borg Rating of Perceived Exertion During the Total Hike [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: 2 weeks ]
    Difference between participants' heart rate during both 17 and 19 pound base backpack weight.

  2. The Borg Rating of Perceived Exertion During Incline and Decline Sections of the participant [ Time Frame: 2 weeks ]
    Participants will report the perceived exertion mid-hike and towards the end. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249986


Contacts
Layout table for location contacts
Contact: Susanne Spano, MD (559)499-6440 sspano@fresno.ucsf.edu
Contact: William Chiang, MD (559)499-6440 wchiang@fresno.ucsf.edu

Locations
Layout table for location information
United States, California
UCSF Fresno Recruiting
Fresno, California, United States, 93703
Contact: Susanne Spano, MD    559-499-6440    sspano@fresno.ucsf.edu   
Contact: William Chiang, MD    (559)499-6440    wchiang@fresno.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Susanne Spano, MD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04249986    
Other Study ID Numbers: 2019126
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No