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Impact of Different Face Masks on Maximal and Submaximal Performance Testing During COVID-19

10 ottobre 2022 aggiornato da: Riphah International University

Individual Performance Analysis of Cardiopulmonary Exercise Testing / Maximal and Sub-maximal Exercise Testing With Different Face Masks

In COVID 19, masks wearability has become a new normal and this "new normal" presented evidence-based performance limitations. The study findings are aimed to objectify parametric changes (if any) and therefore, will assist in making future decisions for testing programs with minimum limitation and maximum protection in this pandemic.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

Victimizing millions of individuals, the novel coronavirus (COVID-19) has made drastic changes in our lives including the obligation of personal protective equipment (PPEs), especially masks. This obligation presented evidence-based performance limitations owing to mask associated airflow resistance, increased ventilatory effort, external air trapping thus elevated carbon dioxide concentration and reuptake, thermal effects, and ventilatory parameters decline along with other physiological, psychological and health-related consequences.

Despite the reported success of vaccination, the use of PPEs especially face masks as one of the non-pharmacological solution to limit viral transmission is a controversial recommendation. With diameter difference between SARS-CoV-2 and mask threads makes viral transmission non-preventable, it however could be reduced partially from 67% to 17% due to the filtration barrier provided by face masks. With new research supporting viral transmission from asymptomatic individuals, the United States Centre of Disease Control (CDC) recommends the use of face masks in an indoor and outdoor setting requiring public interaction where social distancing is unrealistic.

Cardio Pulmonary Exercise Testing (CPET) is an important clinical tool to assess aerobic capacity and has value in predicting outcomes not only in cardiac diseased populations but in other conditions also. Being a gold standard for risk stratification and exercise prescription plans, its application sometimes becomes impractical and thus formulation and utilization of submaximal and graded exercises test proved fruitful in rehabilitation program design in terms of cost efficiency and little expertise requirement for performance. With pandemic in place, the procedure for exercise testing has changed from routine practice. The addition of masks during testing procedures, as per recommendations of CDC to avoid cross-contamination among the health care providers and the participating community, as aerosol generation during exercise testing as a consequence of frequent forceful respiration due to variable exercise intensities thus high discharge rates and farther viral spread.

Both submaximal (6MWT) and maximal (Bruce protocol) exercise tests are commonly used exercise tests in a health care setting with high prognostic and diagnostic values. As per knowledge, there is limited evidence available on testing procedure and therefore the plan is to cover the gaps identified in previous research based on 6MWT and Bruce protocol (mask variability, sample modesty, age restrictions; data on young healthy individuals, few analyzed testing parameters) and note the performance differences if achieved to guide the formulation of structured and standardized approach towards both testing procedures using medically acceptable masks as a general requirement for future testing. As no guidelines had yet been issued to adapt the testing to current situations with PPEs. Analysis of parametric changes in healthy volunteers would aid in the formulation of a recommendation plan for performance analysis measures used in cardiopulmonary settings to ensure minimum performance limitation with added equipment and maintenance of consistency in adaptive testing.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

62

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • AL
      • Islamabad, AL, Pakistan, 44000
        • Riphah Rehabilitation Center
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Riphah International University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Both genders
  • Population from all age groups
  • Healthy Individuals
  • Physically active - screening through Get Active questionnaire
  • Willing to consent

Exclusion Criteria:

  • Cognitively Impaired
  • Participants with absolute or relative contraindication to exercise testing
  • Underlying condition limiting mask wearability
  • Communication gap (language other than Urdu or English)
  • Subjects performing regular physical activity (sports personal)
  • Latent known/diagnosed disease condition
  • People with Long Covid (evaluated via self-reported Post COVID-19 Functional Status Scale)
  • Patients with laboratory diagnosed and symptomatic COVID-19

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Group A
No Mask
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Altro: Group B
Surgical Mask
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Altro: Group C
N95 Mask
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.
Participants fulfilling inclusion exclusion criteria will be asked to sign informed consent. Sealed envelope randomization method would determine order of testing (Group A; No mask, Group B; Surgical mask, Group C; N95 mask). For 6MWT, participants will be asked to walk on 30-meter unimpeded walkway as much as possible & distance at end is recorded along with number of stops during test. For Bruce Protocol, participants will follow standard stage succession with an abrupt increase in speed & inclination by end of each 3-minute cycle. The participants will be advised to perform test till exhaustion and level achieved will be recorded. The analyzed data will then be used to calculate VO2max and MET scores. Heart rate, SPO2, respiratory rate will be recorded at baseline, after 2 minutes and at test completion. BP will be recorded at baseline and at completion of test, while perceived discomfort scale & post-exercise exhaustion scale will be assessed upon completion of exercise testing.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
6MWT (Marked Walking Course, Stop Watch)
Lasso di tempo: After 48 hours

6mwt is a submaximal testing procedure developed by the American Thoracic Society to assess aerobic capacity, endurance, and changes in performance capacity. The test measures the distance covered in 6 Minutes and is intended for all populations with a wide range of diagnoses. The procedure requires a 30-meter unimpeded walkway, a timer, distance markers, turning pointers (cones) and monitoring gadgets (oximeter, Borg's scale), and chairs for the resting period (on requirement). The participants are instructed to walk as much as possible with minimum rests and regular standardized encouragements are provided throughout the test. The distance at the end is recorded along with the number of stops during the test and other parameters. Low distance scores are indicative of reduced performance capacity.

It will be used for sub maximal testing of participants with no mask, surgical mask and wearing N95 mask with the minimum wash out period of 48 hours.

After 48 hours
Bruce Protocol (Treadmill)
Lasso di tempo: After 48 hours
The standard Bruce protocol is the most preferred exercise stress test with validated outcomes and good prognostic values. It is a standard test in cardiology and is divided into successive stages of 3 minutes with an abrupt increase in speed and inclination by the end of each 3-minute cycle. Bruce protocol has 7 stages with starting speed of 1.7 miles/h at 10% inclination (2% inclination increase/stage). The speed change follows as; Level 2 (2.5 miles/h), level 3 (3.4 miles/h), level 4 (4.2 miles/h), level 5 (5.0 miles/h), level 6 (5.5 miles/h) and level 7 (6.0 miles/h) respectively. The participants are advised to perform the test till exhaustion, or the test is suspended based on unlikely events. It will be used for maximal testing of participants with no mask, surgical mask and wearing N95 mask with the minimum wash out period of 48 hours.
After 48 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Modified Borg's Scale for Rate of Perceived Exertion (RPE) (Dyspnea Score)
Lasso di tempo: After 1minute
Modified Borg's scale is a validated and reliable outcome measure to rate subjective perception of exertion and breathlessness. A commonly employed tool used in cardiopulmonary rehabilitation to monitor progress in rehabilitation programs. Borg's scale, the modified version of the original scale proposed by Gunner, is mostly used in the diagnosis of effort-related dyspnea, chest pain, and musculoskeletal pain. The scale consists of a grading score from 0-10 (0; being no exertion at all to 10; being maximal). Subjective perception is rated during the activity. The chosen number from the numeric list denotes the intensity of activity allowing to speed up or slow down activity. The scale takes a few seconds to record responses and can be administered single or multiple times during the process.
After 1minute
Discomfort Perception Scale
Lasso di tempo: After 2 minutes
The discomfort scale is utilized to rate subjective perception about ten sensations of discomfort (Humidity, heat, breathing resistance, itchiness, tightness, saltiness, feeling unfit, odor, fatigue, and overall discomfort). The scale has A 10-point rating scale for response record with 0 representing "none", 5 representing "acceptable" and 10 "very fond of." Low individual scores are indicative of low level of associated discomfort while high scores correspond to greater subjective discomfort perception.
After 2 minutes
Hecimovich-Peiffer-Harbaugh Exercise Exhaustion Scale
Lasso di tempo: After 5minutes
The post-exercise exhaustion scale is a validated and reliable tool to assess exercise-induced acute onset of exhaustion. The scale consists of 14 items that are measured by a 10-point Likert type frequency/intensity scale of response categories anchored at extreme ends by 'not at all to 'extremely difficult'. High scores are associated with elevated post-exercise exhaustion.
After 5minutes

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 dicembre 2021

Completamento primario (Effettivo)

1 agosto 2022

Completamento dello studio (Effettivo)

15 settembre 2022

Date di iscrizione allo studio

Primo inviato

23 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

3 dicembre 2021

Primo Inserito (Effettivo)

9 dicembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Syeda Rida Batool

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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