Functional CapacityNCT06839521
6-Minute Walk Test Assessment Via Mobile App
An observational study of Functional Capacity, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to develop an Android-based 6-Minute Walk Test (6MWT) application to facilitate quick and efficient functional capacity assessment in clinical settings. The project will be carried out by a multidisciplinary team of software engineers and physiotherapists, with algorithms developed for both indoor and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Capacity
- What is being tested?
- Walk Test-T and Walk Test-A
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 15 May 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be conducted with healthy individuals.
Who may be able to join
- Not having a disease that prevents walking
- To be able to use a smartphone
Who cannot join
- Exercise restriction for any reason
- Pregnancy or any known cardiovascular, pulmonary, neurological, metabolic or haematological disease
- Having any problem that prevents communication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development, Validity and Reliability of Android Based 6 Minute Walking Test
This study aims to develop an Android-based 6-Minute Walk Test (6MWT) application to facilitate quick and efficient functional capacity assessment in clinical settings. The project will be carried out by a multidisciplinary team of software engineers and physiotherapists, with algorithms developed for both indoor and outdoor environments. As GPS signals may be lost indoors, the program will utilize the phone's gyroscope for distance measurement, while GPS signals will be used outdoors. The study will include healthy individuals aged 18-65, without any exercise restrictions. Participants' demographic data will be recorded, and the 6MWT will be conducted according to traditional protocols. During the test, parameters such as heart rate, oxygen saturation, and walking distance will be measured and compared with traditional methods. The Android application will provide auditory and vibration cues at the start and end of the test and will report health data in real-time. The data will be presented as mean ± standard deviation for continuous variables, and the test reliability will be assessed using the test-retest method. Results will be reported as age- and gender-adjusted z-scores for objective functional decline.
Read the detailed description
The 6-minute walk test (6MWT) is a widely used test for the objective assessment of functional exercise capacity in the management of patients with moderate to severe lung disease.Unlike pulmonary function testing, 6DYT captures the often coexisting extrapulmonary manifestations of chronic respiratory disease, including cardiovascular disease, frailty, sarcopenia and cancer. Unlike the cardiopulmonary exercise stress test, this test does not require complex equipment or technical expertise. In this low-complexity, safe test, the patient is asked to walk as far as possible along a 30 m corridor for a 6-min period, with the primary outcome measure being the 6-min walking distance in metres.In a healthcare setting, measurement of exercise capacity is important to understand a person's current status and to assess rehabilitation progress. The 6-minute walk test (6MWT), which measures the distance walked in 6 minutes, is a widely used clinical tool for this purpose. A smartphone with integrated sensors provides a suitable platform for wearable biomechanical applications. With a wearable system for 6DYT and minimal additional setup, additional information can be obtained and clinically useful and immediate output can be provided to assess physical function and gait characteristics without the need to purchase specialised medical equipment.Wearable sensors allow a person to walk freely at a self-selected and natural pace that is more representative of everyday life than some laboratory conditions.Many studies have used accelerometers to detect gait and calculate gait parameters such as cadence, step timing and symmetry. Accelerometers can also be used to assess physical activity levels in relation to 6DYT results.In a systematic review published in 2015, 47 applications related to smoking cessation, 7 applications related to hernia, 42 applications related to diabetes, 103 applications related to asthma, 19 applications related to personal health records, 69 applications related to HIV, 29 applications related to colorectal diseases, 46 applications related to cancer, 104 applications related to pain management and 26 applications related to bariatric surgery were used.When the literature was reviewed, studies on the android-based application of 6DYT were conducted, but no application was found in Android application markets. Therefore, the aim of our study is to develop an Android-based 6 Minute Walk Test and to investigate its validity and reliability.
- Conditions
- Functional Capacity
- Being tested
- Walk Test-T, Walk Test-A
- Keywords
- 6-Minute Walk Test, Android, Validity, Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk Test-TOther
6MWT will be conducted according to traditional protocols. During the test, parameters such as heart rate, oxygen saturation, and walking distance will be measured and compared with traditional methods.
Walk Test-AOther
In order to develop Android-based 6DYT, the system will be designed with a multidisciplinary team consisting of software engineer and physiotherapist. In this programme, separate algorithms will be developed for indoor and outdoor environments so that individuals can be evaluated in a hospital environment, at home or in daily life. In indoor environments, the GPS signal is lost or there is not enough signal strength. For this reason, the programme will be developed so that the gyroscope of the phone can be used for distance measurement. GPS signals will be used outdoors. In this way, the physical activity level of the individual both in the hospital and in daily life will be measured.
| Study group | Role | What they receive |
|---|---|---|
| WalkTest-T | Traditional 6-minute walk test will be applied. Receives: Other: Walk Test-T; Other: Walk Test-A | |
| Walk Test-A | Mobile application of 6-minute test will be applied. Receives: Other: Walk Test-T; Other: Walk Test-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test
Before and after the test, participants' height, body weight, resting heart rate, oxygen saturation, blood pressure, Borg Dyspnea, and fatigue levels are assessed. The test follows American Thoracic Society (ATS) guidelines in a 30-meter covered corridor. At the start and end, participants receive audible and vibration cues. The app notifies the remaining time, and pulse oximeter data is displayed in real time. The practitioner can monitor walking distance, heart rate, and oxygen saturation. At the end of the test, results are reported to both the participant and practitioner. Additional data, including step count, cadence, and step symmetry, are also calculated.
Measured: Before and up to 2 weeks
SpO2
In the evaluation, SpO2 will be measured with a Bluetooth pulse oximeter that sends synchronised information flow to the application at the beginning, middle, and end of 6 minutes. In addition, the application will report the average of the SpO2 obtained from the entire test.
Measured: Before and up to 2 weeks
Modified Borg Scale
It is a scale commonly used to assess exertional dyspnoea severity and rest dyspnoea severity. It consists of ten items describing the severity of dyspnoea according to degrees. The fact that the severity of dyspnoea is defined in the Modified Borg Scale (MBS) makes it easier for patients to apply. In this scale, symptom intensity is displayed progressively in a 0-10 score, representing the "absence of dyspnea" and "maximum dyspnea" respectively. Higher scores mean a worse outcome.
Measured: Before and up to 2 weeks
Walking distance
Walking distance measurement will be performed according to 6DYT protocols. It will also be compared with the data from the smartphone.
Measured: Before and up to 2 weeks
International Physical Activity Questionnaire - Short Form (IPA-SF)
It is one of the most commonly used questionnaires to assess physical activity. Information can be collected by telephone, interview or self-administration. The short form is generally preferred because the long form is repetitive. The short form consists of seven questions and provides information about the time spent by the individual in sitting, walking, moderate and vigorous activities. The question types can vary from 'Last seven days' to 'Any week'.
Measured: Before and up to 2 weeks
Heart Rate
In the evaluation, heart rate will be measured with a Bluetooth pulse oximeter that sends synchronised information flow to the application at the beginning, middle, and end of 6 minutes. In addition, the application will report the average heart rate obtained from the entire test.
Measured: Before and up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start30 May 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Other
- Time perspective
- Other
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Ferruh Taspinar, Prof. Dr., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839521
- Sponsor's protocol ID
- Android-35
- Status last verified
- Apr 2025
- First submitted
- 5 Feb 2025
- Last updated
- 30 Apr 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validity and Reliability of Android Based 6 Minute Walking Test
- ClinicalTrials.gov ID
- NCT06839521
- Acronym / sponsor ID
- Android-35
- Conditions
- Functional Capacity
- Keywords
- 6-Minute Walk Test, Android, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 21 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.
This study aims to develop an Android-based 6-Minute Walk Test (6MWT) application to facilitate quick and efficient functional capacity assessment in clinical settings. The project will be carried out by a multidisciplinary team of software engineers and physiotherapists, with algorithms developed for both indoor and outdoor environments. As GPS signals may be lost indoors, the program will utilize the phone's gyroscope for distance measurement, while GPS signals will be used outdoors. The study will include healthy individuals aged 18-65, without any exercise restrictions. Participants' demographic data will be recorded, and the 6MWT will be conducted according to traditional protocols. During the test, parameters such as heart rate, oxygen saturation, and walking distance will be measured and compared with traditional methods. The Android application will provide auditory and vibration cues at the start and end of the test and will report health data in real-time. The data will be presented as mean ± standard deviation for continuous variables, and the test reliability will be assessed using the test-retest method. Results will be reported as age- and gender-adjusted z-scores for objective functional decline.
Detailed description
The 6-minute walk test (6MWT) is a widely used test for the objective assessment of functional exercise capacity in the management of patients with moderate to severe lung disease.Unlike pulmonary function testing, 6DYT captures the often coexisting extrapulmonary manifestations of chronic respiratory disease, including cardiovascular disease, frailty, sarcopenia and cancer. Unlike the cardiopulmonary exercise stress test, this test does not require complex equipment or technical expertise. In this low-complexity, safe test, the patient is asked to walk as far as possible along a 30 m corridor for a 6-min period, with the primary outcome measure being the 6-min walking distance in metres.In a healthcare setting, measurement of exercise capacity is important to understand a person's current status and to assess rehabilitation progress. The 6-minute walk test (6MWT), which measures the distance walked in 6 minutes, is a widely used clinical tool for this purpose. A smartphone with integrated sensors provides a suitable platform for wearable biomechanical applications. With a wearable system for 6DYT and minimal additional setup, additional information can be obtained and clinically useful and immediate output can be provided to assess physical function and gait characteristics without the need to purchase specialised medical equipment.Wearable sensors allow a person to walk freely at a self-selected and natural pace that is more representative of everyday life than some laboratory conditions.Many studies have used accelerometers to detect gait and calculate gait parameters such as cadence, step timing and symmetry. Accelerometers can also be used to assess physical activity levels in relation to 6DYT results.In a systematic review published in 2015, 47 applications related to smoking cessation, 7 applications related to hernia, 42 applications related to diabetes, 103 applications related to asthma, 19 applications related to personal health records, 69 applications related to HIV, 29 applications related to colorectal diseases, 46 applications related to cancer, 104 applications related to pain management and 26 applications related to bariatric surgery were used.When the literature was reviewed, studies on the android-based application of 6DYT were conducted, but no application was found in Android application markets. Therefore, the aim of our study is to develop an Android-based 6 Minute Walk Test and to investigate its validity and reliability.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WalkTest-T | – | Other: Walk Test-T, Other: Walk Test-ATraditional 6-minute walk test will be applied. |
| Walk Test-A | – | Other: Walk Test-T, Other: Walk Test-AMobile application of 6-minute test will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted with healthy individuals.
Key inclusion criteria (2 listed)
- Not having a disease that prevents walking
- To be able to use a smartphone
Key exclusion criteria (3 listed)
- Exercise restriction for any reason
- Pregnancy or any known cardiovascular, pulmonary, neurological, metabolic or haematological disease
- Having any problem that prevents communication
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 |
|---|---|---|
| Walk Test-T6MWT will be conducted according to traditional protocols. During the test, parameters such as heart rate, oxygen saturation, and walking distance will be measured and compared with traditional methods. | Other | Walk Test-A, WalkTest-T |
| Walk Test-AIn order to develop Android-based 6DYT, the system will be designed with a multidisciplinary team consisting of software engineer and physiotherapist. In this programme, separate algorithms will be developed for indoor and outdoor environments so that individuals can be evaluated in a hospital environment, at home or in daily life. In indoor environments, the GPS signal is lost or there is not enough signal strength. For this reason, the programme will be developed so that the gyroscope of the phone can be used for distance measurement. GPS signals will be used outdoors. In this way, the physical activity level of the individual both in the hospital and in daily life will be measured. | Other | Walk Test-A, WalkTest-T |
Primary outcome
6-Minute Walk Test
Time frame: Before and up to 2 weeks
Before and after the test, participants' height, body weight, resting heart rate, oxygen saturation, blood pressure, Borg Dyspnea, and fatigue levels are assessed. The test follows American Thoracic Society (ATS) guidelines in a 30-meter covered corridor. At the start and end, participants receive audible and vibration cues. The app notifies the remaining time, and pulse oximeter data is displayed in real time. The practitioner can monitor walking distance, heart rate, and oxygen saturation. At the end of the test, results are reported to both the participant and practitioner. Additional data, including step count, cadence, and step symmetry, are also calculated.
SpO2
Time frame: Before and up to 2 weeks
In the evaluation, SpO2 will be measured with a Bluetooth pulse oximeter that sends synchronised information flow to the application at the beginning, middle, and end of 6 minutes. In addition, the application will report the average of the SpO2 obtained from the entire test.
Modified Borg Scale
Time frame: Before and up to 2 weeks
It is a scale commonly used to assess exertional dyspnoea severity and rest dyspnoea severity. It consists of ten items describing the severity of dyspnoea according to degrees. The fact that the severity of dyspnoea is defined in the Modified Borg Scale (MBS) makes it easier for patients to apply. In this scale, symptom intensity is displayed progressively in a 0-10 score, representing the "absence of dyspnea" and "maximum dyspnea" respectively. Higher scores mean a worse outcome.
Walking distance
Time frame: Before and up to 2 weeks
Walking distance measurement will be performed according to 6DYT protocols. It will also be compared with the data from the smartphone.
International Physical Activity Questionnaire - Short Form (IPA-SF)
Time frame: Before and up to 2 weeks
It is one of the most commonly used questionnaires to assess physical activity. Information can be collected by telephone, interview or self-administration. The short form is generally preferred because the long form is repetitive. The short form consists of seven questions and provides information about the time spent by the individual in sitting, walking, moderate and vigorous activities. The question types can vary from 'Last seven days' to 'Any week'.
Heart Rate
Time frame: Before and up to 2 weeks
In the evaluation, heart rate will be measured with a Bluetooth pulse oximeter that sends synchronised information flow to the application at the beginning, middle, and end of 6 minutes. In addition, the application will report the average heart rate obtained from the entire test.
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 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Ferruh Taspinar, Prof. Dr. principal investigator
Izmir Democracy University
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 Functional Capacity, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Apr 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 Turkey (Türkiye). 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?
Contact Betül Taspinar, Prof. Dr. (+90 506 680 44 26, betul.taspinar@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (time frame: Before and up to 2 weeks). The study lists 6 primary outcomes in all. 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 30 Apr 2025.