6-Minute Walk Test Assessment Via Mobile App

NCT06839521 | Not Yet Recruiting

• 1 other identifier: Android-35
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Functional Capacity

Keywords

6-Minute Walk Test; Android; Validity; Reliability

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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'.

  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.

  Before and up to 2 weeks

Study Arms (2)

WalkTest-T

Traditional 6-minute walk test will be applied.

Other: Walk Test-T; Other: Walk Test-A

Walk Test-A

Mobile application of 6-minute test will be applied.

Other: Walk Test-T; Other: Walk Test-A

Interventions

Walk Test-T OTHER

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-A; WalkTest-T

Walk Test-A OTHER

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.

Walk Test-A; WalkTest-T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will be conducted with healthy individuals.

You may qualify if:

• Not having a disease that prevents walking
• To be able to use a smartphone

You may not qualify if:

• Exercise restriction for any reason
• Pregnancy or any known cardiovascular, pulmonary, neurological, metabolic or haematological disease
• Having any problem that prevents communication

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Location

Study Officials

• Ferruh Taspinar, Prof. Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Taspinar, Prof. Dr.

CONTACT

+90 506 680 44 26; betul.taspinar@idu.edu.tr

Kubilay Güngörer, Msc. Pt.

CONTACT

+90 554 161 38 04; kubilaygungorer@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 21, 2025
• Study Start: May 30, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)