NCT06805422

Brief Summary

Health-related physical fitness (HRPF) has demonstrated high clinical relevance, and its level is associated with the ability to perform activities of daily living with vigor and a lower risk of chronic disease. Consequently, exercise prescription guidelines recommend improving HRPF as a focus for prevention and rehabilitation programs. Measuring and tracking HRPF often requires specialized equipment and personnel, which are expensive and less applicable to the general population. Wearables may mitigate this issue by providing useful estimates of the HRPF.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 1, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

January 27, 2025

Last Update Submit

August 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum Oxygen Consumption (VO2max)

    Maximum oxygen consumption (VO2max) will be measured using a standard Ramp protocol on a standardized treadmill.

    Performed 14-day after wearing the smartwatch

Secondary Outcomes (3)

  • % fat free mass

    Performed at baseline and 14-days after wearing the smartwatch

  • Sit-and-reach distance

    Performed at baseline and 14-days after wearing the smartwatch

  • # of Push-up completed

    Performed at baseline and 14-days after wearing the smartwatch

Study Arms (4)

Aerobically trained

actively engaged in aerobic exercise training for at least 2 years

Strength trained

actively engaged in weight training

Not actively training

not engaged in regular aerobic or weight training exercise

Highly flexible

determined by their flexibility scores

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

he study population consists of healthy adult individuals categorized into four distinct groups based on their physical activity habits and fitness characteristics. These groups include: Aerobically Trained Individuals Participants actively engaged in aerobic exercise training (e.g., running, cycling, swimming) for at least two years. Likely to have higher cardiovascular fitness and endurance levels compared to other groups. Strength-Trained Individuals Participants actively engaged in regular weight training or resistance exercises. Expected to exhibit higher levels of muscle strength and hypertrophy. Non-Training Individuals Participants who are not engaged in regular aerobic or weight training exercises. Represent a baseline or control group with typical sedentary or minimally active lifestyles. Highly Flexible Individuals Participants identified by achieving high scores on flexibility assessments, regardless of their training status. Expected to have greater joint range of mot

You may qualify if:

  • Group 1 (Aerobically Trained)
  • years old
  • actively training or competing over the past 2 years
  • or more days of vigorous activity accumulating approximately least 1500 MET min/week or 7 days of any combination of walking, moderate, or vigorous intense activities achieving a minimum of 3000 MET min/week
  • Group 2 (Strength trained)
  • years old
  • actively training or competing over the past 2 years
  • or more days of muscle-strengthening exercise at an intensity of approximately 5 out of 10
  • Group 3 (Not actively training)
  • years old
  • actively training or competing over the past 2 years
  • or more days of muscle-strengthening exercise at an intensity of approximately 5 out of 10
  • Group 5 (High flexibility)
  • years old
  • Sit-and-reach performance is categorized as "very good" or excellent based on the American College of Sports Medicine's sit-and-reach evaluation criteria (Table 4.16 of ACSM's Guidelines for Exercise Testing and Prescription 9th edition).

You may not qualify if:

  • History of cardiovascular disease (Cardiac, peripheral vascular, or cerebrovascular disease)
  • History of stable or unstable angina
  • History of cardiac dysrhythmias causing symptoms or hemodynamic consequences
  • History of hypertrophic cardiomyopathy
  • History of cardiac valvular disease (e.g., aortic stenosis)
  • History of pulmonary disease (Chronic obstructive pulmonary disease, asthma, interstitial lung disease, or cystic fibrosis)
  • History of pulmonary embolus
  • History of suspected or known aneurysm
  • History of metabolic disease (Diabetes mellitus (type I or II), thyroid disorders, renal or liver disease
  • History of renal disease
  • History of neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise
  • Current acute systemic infection, accompanied by fever and body aches.
  • Pain or discomfort in the chest, neck, jaw, arms, or other areas that may be due to myocardial ischemia (lack of adequate circulation)
  • Shortness of breath at rest, during daily activities, or with mild exertion
  • Dizziness or syncope (fainting)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas State Univeristy

Manhattan, Kansas, 66506, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 3, 2025

Study Start

January 1, 2025

Primary Completion

August 20, 2025

Study Completion

December 25, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations