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Active, Not Recruiting

NCT Number: NCT06805422

Health-Related Physical Fitness Level From Smartwatches

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kansas State Univeristy

Manhattan, Kansas, 66506, United States

About this study

Health-related physical fitness (HRPF) has high clinical relevance [1]. It is associated with the ability to perform activities of daily living with vigor and a lower risk of chronic disease [2]. Consequently, exercise prescription guidelines recommend improving HRPF as a focus for prevention and rehabilitation programs [3]. The American College of Sports Medicine (ACSM) [3] grouped the HRFP into five domains: cardiorespiratory endurance, body composition, muscular strength, muscular endurance, and flexibility. However, measuring and tracking the fitness levels for all HRPF domains requires specialized laboratory equipment and personnel, which are expensive and less applicable to the general population. Wearable technology mitigates this issue and has proven to be a reliable alternative capable of providing useful estimates of the HRPF [4] [5] [6, 7]. Previous work has predicted ACSM HRPF domains from anthropometric and laboratory bioelectrical impedance analysis data (BIA) [8] [9]. Nevertheless, their data are based on the National Fitness Award (NFA), a nationwide test used to assess the physical fitness of the general South Korean population that is collected using specialized laboratory equipment under the supervision of health professionals.

Current advances in wearables may allow us to estimate the fitness level for all HRPF domains using only smartwatch data, enabling economic, non-intrusive predictions and being available during the user's daily routine. The complete characterization of health-related fitness as a multidimensional depiction of the user's fitness status can be used to track health status continuously and to design specialized training prescriptions. The main goal of this study is to estimate the fitness level for all HRFP domains from data obtained from smartwatches during unsupervised activities of daily living. We hypothesized that data from smartwatches could be used to estimate the fitness levels from all HRPF domains.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1 (Aerobically Trained)

  • 20-60 years old
  • actively training or competing over the past 2 years
  • 3 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)

  • 20-60 years old
  • actively training or competing over the past 2 years
  • 3 or more days of muscle-strengthening exercise at an intensity of approximately 5 out of 10

Group 3 (Not actively training)

  • 20-60 years old
  • actively training or competing over the past 2 years
  • 3 or more days of muscle-strengthening exercise at an intensity of approximately 5 out of 10

Group 5 (High flexibility)

  • 20-60 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).

Exclusion criteria

Exclusion criteria

are the same for all groups.

  • 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)
  • Orthopnea (breathing discomfort when not in an upright position) or paroxysmal nocturnal dyspnea (interrupted breathing at night)
  • Ankle edema (swelling)
  • Palpitations (abnormal rapid beating of the heart) or tachycardia (rapid heartbeat)
  • Intermittent claudication (cramping pain and weakness in legs, especially calves, during walking due to inadequate blood supply to muscles)
  • Known heart murmur (atypical heart sound indicating a structural or functional abnormality)
  • Unusual or unexplained fatigue
  • Severe arterial hypertension (i.e., systolic blood pressure of >200 mm Hg and/or a diastolic blood pressure of >110 mm Hg) at rest.

Treatment and study plan

Primary outcomes

  1. Maximum Oxygen Consumption (VO2max)

    Time frame: Performed 14-day after wearing the smartwatch

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

Secondary outcomes

  1. % fat free mass

    Time frame: Performed at baseline and 14-days after wearing the smartwatch

    Bio-electrical impedance will be used to assess % fat free mass

  2. Sit-and-reach distance

    Time frame: Performed at baseline and 14-days after wearing the smartwatch

    Following a brief warm-up (including stretching exercises, cycling, or treadmill (less than 5 minutes)), participants will be instructed to sit on the floor with their legs extended and feet flat, without shoes, against the front of the test box. Upon command, the participant will slowly and steadily lean forward at the hips, keeping the knees straight and sliding their hand up the ruler as far as possible, ensuring that both hands reach an equal distance during the test and that the subject's knees remain grounded. The distance reached in centimeters will be recorded.

  3. # of Push-up completed

    Time frame: Performed at baseline and 14-days after wearing the smartwatch

    Upper body endurance will be assessed via a standard push-up test. The total number of correctly executed push-ups will be recorded

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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