- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06805422
Health-Related Physical Fitness Level From Smartwatches
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Kansas
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Manhattan, Kansas, United States, 66506
- Kansas State Univeristy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Aerobically trained
actively engaged in aerobic exercise training for at least 2 years
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Strength trained
actively engaged in weight training
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Not actively training
not engaged in regular aerobic or weight training exercise
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Highly flexible
determined by their flexibility scores
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maximum Oxygen Consumption (VO2max)
Time Frame: Performed 14-day after wearing the smartwatch
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Maximum oxygen consumption (VO2max) will be measured using a standard Ramp protocol on a standardized treadmill.
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Performed 14-day after wearing the smartwatch
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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% fat free mass
Time Frame: Performed at baseline and 14-days after wearing the smartwatch
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Bio-electrical impedance will be used to assess % fat free mass
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Performed at baseline and 14-days after wearing the smartwatch
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Sit-and-reach distance
Time Frame: Performed at baseline and 14-days after wearing the smartwatch
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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.
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Performed at baseline and 14-days after wearing the smartwatch
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# of Push-up completed
Time Frame: Performed at baseline and 14-days after wearing the smartwatch
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Upper body endurance will be assessed via a standard push-up test.
The total number of correctly executed push-ups will be recorded
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Performed at baseline and 14-days after wearing the smartwatch
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KansasSU
- IRB-12223 (Other Identifier: Kansas State University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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