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临床试验/NCT05150613
NCT05150613已完成不适用

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

Riphah International University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年12月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
6MWT (Marked Walking Course, Stop Watch)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

Single blinding method will be employed to limit possible participant influence on test results (anticipation bias)

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Group A

Other

No Mask

干预措施: No Mask (Other)

Group A

Other

No Mask

干预措施: Surgical Mask (Other)

Group A

Other

No Mask

干预措施: N95 Mask (Other)

Group B

Other

Surgical Mask

干预措施: Surgical Mask (Other)

Group B

Other

Surgical Mask

干预措施: N95 Mask (Other)

Group B

Other

Surgical Mask

干预措施: No Mask (Other)

Group C

Other

N95 Mask

干预措施: No Mask (Other)

Group C

Other

N95 Mask

干预措施: Surgical Mask (Other)

Group C

Other

N95 Mask

干预措施: N95 Mask (Other)

结局指标

主要结局

6MWT (Marked Walking Course, Stop Watch)

时间窗: 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.

Bruce Protocol (Treadmill)

时间窗: 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.

次要结局

  • Modified Borg's Scale for Rate of Perceived Exertion (RPE) (Dyspnea Score)(After 1minute)
  • Discomfort Perception Scale(After 2 minutes)
  • Hecimovich-Peiffer-Harbaugh Exercise Exhaustion Scale(After 5minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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