Exertion; ExcessNCT04249986
Backpack Weight Impacts
A study testing The Borg Rating of Perceived Exertion in people with Exertion; Excess, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exertion; Excess
- What is being tested?
- The Borg Rating of Perceived Exertion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lower extremity injuries or surgeries in the past 6-months
- Daily Smokers
- Chronic medical problems:
- Hypertension
- High cholesterol
- Diabetes
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Backpack Weight Impacts on Perceived Exertion and Heart Rate Variability
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.
- Conditions
- Exertion; Excess
- Being tested
- The Borg Rating of Perceived Exertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Borg Rating of Perceived ExertionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: The Borg Rating of Perceived Exertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (2)
Heart Rate
Difference between participants' heart rate during both 17 and 19 pound base backpack weight.
Measured: 2 weeks
The Borg Rating of Perceived Exertion During Incline and Decline Sections of the participant
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start21 Feb 2020
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exertion; ExcessStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Spano, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249986
- Sponsor's protocol ID
- 2019126
- Status last verified
- Aug 2024
- First submitted
- 24 Jan 2020
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Backpack Weight Impacts on Perceived Exertion and Heart Rate Variability
- ClinicalTrials.gov ID
- NCT04249986
- Acronym / sponsor ID
- 2019126
- Conditions
- Exertion; Excess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Borg Rating of Perceived Exertion between 17 and 19 lb BPW | Active comparator | Behavioral: The Borg Rating of Perceived ExertionParticipants 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. |
| The Borg Rating of Perceived Exertion between 19 and 17 lb BPW | Active comparator | Behavioral: The Borg Rating of Perceived ExertionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- Lower extremity injuries or surgeries in the past 6-months
- Daily Smokers
- Chronic medical problems:
- Hypertension
- High cholesterol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Borg Rating of Perceived ExertionParticipants 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. | Behavioural | The Borg Rating of Perceived Exertion between 17 and 19 lb BPW, The Borg Rating of Perceived Exertion between 19 and 17 lb BPW |
Primary outcome
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.
2 secondary outcomes
Heart Rate
Time frame: 2 weeks
The Borg Rating of Perceived Exertion During Incline and Decline Sections of the participant
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Spano, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Borg Rating of Perceived Exertion in people with Exertion; Excess, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Borg Rating of Perceived Exertion During the Total Hike (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024; AzTrials last refreshed its copy on 27 Oct 2026.