Acute Mask Effects on Walk Distance and Vital Signs

NCT06634238 | Not Yet Recruiting

• 1 other identifier: GAZİ UNIVERSİTY
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this prospective observational study is to investigate the acute effects of mask use on walking distance and vital signs in healthy individuals aged 18-24 years. The main questions it aims to answer are: Does wearing a mask affect walking distance during the Incremental Shuttle Walk Test (ISWT)? How does mask use influence heart rate, oxygen saturation, blood pressure, and respiratory rate during the test? Researchers will compare participants performing the ISWT with a mask to those performing it without a mask to determine any differences in walking distance and vital signs. Participants will: Complete the ISWT twice: once with a mask and once without a mask, on separate days. Have their heart rate, oxygen saturation, respiratory rate, blood pressure, and dyspnea perception measured before and after each test.

Conditions

Mask Usage Condition

Keywords

Mask; vital signs; shuttle walk test

Outcome Measures

Primary Outcomes (5)

• Heart rate

  Heart rate will be evaluated using a heart rate monitor (Polar FT 100).

  Before the test and immediately after the test

• Oxygen saturation

  Oxygen saturation will be evaluated with a portable pulse oximeter.

  Before the test and immediately after the test

• Blood pressure

  Blood pressure will be evaluated by sphygmomanometer.

  Before the test and immediately after the test

• Respiratory frequency

  Respiratory frequency will be evaluated by counting the number of breaths in a minute, and dyspnea perception was evaluated using the Modified Borg Scale.

  Before the test and immediately after the test

• Dyspnea perception

  Dyspnea perception will be evaluated using the Modified Borg Scale.

  Before the test and immediately after the test

Study Arms (2)

Masked Group

Participants who performed the Incremental Shuttle Walk Test (ISWT) while wearing a face mask.

Other: Incremental shuttle walk test

Unmasked Group

Participants who performed the Incremental Shuttle Walk Test (ISWT) without wearing a face mask.

Other: Incremental shuttle walk test

Interventions

Incremental shuttle walk test OTHER

Participants were recommended to wear comfortable clothing and appropriate shoes for the test. To minimize variability, one masked and one unmasked ISWT was performed on the same participant at the same time of day, one day apart

Masked Group; Unmasked Group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy volunteers, aged between 18 and 24 years, with a body mass index (BMI) of less than 30 kg/m². All participants are free from any known chronic or acute diseases, do not take prescription medications (except for oral contraception), and have no history of drug, alcohol, or cigarette use. Additionally, participants with blood pressure greater than 160/100 mmHg or those with known pregnancy status are excluded from the study.

You may qualify if:

• Individuals aged 18-24 years.
• Body mass index of less than 30 kg/m².
• No known diseases

You may not qualify if:

• Individuals with a self-reported history of chronic or acute disease/dysfunction that contraindicates or limits participation in exercise testing.
• Individuals taking prescription medications other than oral contraception.
• Those with known pregnancy status.
• Individuals who use drugs, cigarettes, or alcohol.
• Individuals with blood pressure greater than ≥160/100 mmHg.

Sponsors & Collaborators

• Nagihan Acet: lead

Related Publications (7)

• Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.

  PMID: 1494764 BACKGROUND

• Probst VS, Hernandes NA, Teixeira DC, Felcar JM, Mesquita RB, Goncalves CG, Hayashi D, Singh S, Pitta F. Reference values for the incremental shuttle walking test. Respir Med. 2012 Feb;106(2):243-8. doi: 10.1016/j.rmed.2011.07.023. Epub 2011 Aug 23.

  PMID: 21865021 BACKGROUND

• Parreira VF, Janaudis-Ferreira T, Evans RA, Mathur S, Goldstein RS, Brooks D. Measurement properties of the incremental shuttle walk test. a systematic review. Chest. 2014 Jun;145(6):1357-1369. doi: 10.1378/chest.13-2071.

  PMID: 24384555 BACKGROUND

• Burdon JG, Juniper EF, Killian KJ, Hargreave FE, Campbell EJ. The perception of breathlessness in asthma. Am Rev Respir Dis. 1982 Nov;126(5):825-8. doi: 10.1164/arrd.1982.126.5.825.

  PMID: 7149447 BACKGROUND

• Grant S, Aitchison T, Henderson E, Christie J, Zare S, McMurray J, Dargie H. A comparison of the reproducibility and the sensitivity to change of visual analogue scales, Borg scales, and Likert scales in normal subjects during submaximal exercise. Chest. 1999 Nov;116(5):1208-17. doi: 10.1378/chest.116.5.1208.

  PMID: 10559077 BACKGROUND

• Wu G, Sanderson B, Bittner V. The 6-minute walk test: how important is the learning effect? Am Heart J. 2003 Jul;146(1):129-33. doi: 10.1016/S0002-8703(03)00119-4.

  PMID: 12851620 BACKGROUND

• Goncalves CG, Mesquita R, Hayashi D, Merli MF, Vidotto LS, Fernandes KB, Probst VS. Does the Incremental Shuttle Walking Test require maximal effort in healthy subjects of different ages? Physiotherapy. 2015 Jun;101(2):141-6. doi: 10.1016/j.physio.2014.11.002. Epub 2014 Nov 11.

  PMID: 25700634 BACKGROUND

Study Officials

• Murat Esmer

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagihan Acet, Phd.

CONTACT

05322052605; nagihan.acet@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 9, 2024
• Study Start: October 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10