Exercise CapacityNCT06805422
Health-Related Physical Fitness Level From Smartwatches
An observational study of Exercise Capacity and Flexibility, run by Kansas State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Capacity, Flexibility, Strength and Endurance
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 25 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Show all 15Show fewer
- 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).
Who cannot join
- 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)
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Exercise Capacity, Flexibility, Strength and Endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Oxygen Consumption (VO2max)
Maximum oxygen consumption (VO2max) will be measured using a standard Ramp protocol on a standardized treadmill.
Measured: Performed 14-day after wearing the smartwatch
Secondary outcomes (3)
% fat free mass
Bio-electrical impedance will be used to assess % fat free mass
Measured: Performed at baseline and 14-days after wearing the smartwatch
Sit-and-reach distance
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.
Measured: Performed at baseline and 14-days after wearing the smartwatch
# of Push-up completed
Upper body endurance will be assessed via a standard push-up test. The total number of correctly executed push-ups will be recorded
Measured: Performed at baseline and 14-days after wearing the smartwatch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Jan 2025
- Primary completion20 Aug 2025
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise CapacityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Ade, M.S., Ph.D., Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805422
- Sponsor's protocol ID
- KansasSU
- Other IDs
- IRB-12223
- Status last verified
- Aug 2025
- First submitted
- 27 Jan 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Physical Fitness Level From Smartwatches
- ClinicalTrials.gov ID
- NCT06805422
- Acronym / sponsor ID
- KansasSU
- Conditions
- Exercise Capacity, Flexibility, Strength and Endurance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 3 Feb 2025 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
% fat free mass
Time frame: Performed at baseline and 14-days after wearing the smartwatch
Sit-and-reach distance
Time frame: Performed at baseline and 14-days after wearing the smartwatch
# of Push-up completed
Time frame: Performed at baseline and 14-days after wearing the smartwatch
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Exercise Capacity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD)
Respiratory Diseases
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
COPD (Chronic Obstructive Pulmonary Disease)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Capacity and Flexibility, run by Kansas State University 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 15 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maximum Oxygen Consumption (VO2max) (time frame: Performed 14-day after wearing the smartwatch). 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 26 Aug 2025.