Influence of Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults

August 6, 2021 updated by: Rana Elbanna, Cairo University

Influence of Surgical Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults

Subjects had randomly divided into two groups. All will do aerobic exercise in form of treadmill but Group (A) will do while wearing surgical mask and Group (B) without surgical mask. To detect the Influence of surgical mask on functional capacity and quality of life during controlled endurance exercise in sedentary adults

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Group (A):

  1. Each subject will sign a consent form after receiving a detailed explanation about the procedure.
  2. Functional capacity and Quality of life will be evaluated before the start of the training.
  3. Subjects in group A will wear surgical mask before starting of the session. 4.3 sessions will be done every week for 3 months.

5.The session will start with warming up for 5 minutes then 25 minutes of aerobic exercise on the treadmill with moderate intensity followed by cooling down for 5 minutes.

6.After finishing the program, the participant will be evaluated to detect the effect of the exercise.

Group (B):

  1. Each subject will sign a consent form after receiving a detailed explanation about the procedure.
  2. Functional capacity and Quality of life will be evaluated before the start of the training.
  3. Subjects in group A will not wear any mask during the session. 4.3 sessions will be done every week for 3 months.

5.The session will start with warming up for 5 minutes then 25 minutes of aerobic exercise on the treadmill with moderate intensity followed by cooling down for 5 minutes.

6.After finishing the program, the participant will be evaluated to detect the effect of the exercise.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Recruiting
        • Outpatient clinic faculty of physical therapy at Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 100 participants
  • 30 to 40 years of age
  • both sex

Exclusion Criteria:

  • uncontrolled cardiopulmonary conditions,
  • sever un treated orthopedic condition
  • uncontrolled neurological conditions,)
  • uncontrolled diabetes,
  • claustrophobia,
  • pregnancy
  • Recent COVID-19 infection,)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical Mask Group
participants of both sexes who will perform controlled endurance exercise on treadmill while wearing surgical mask
Device: Treadmill
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
Experimental: Non mask Group
participants of both sexes who will perform controlled endurance exercise on treadmill without wearing surgical mask
Device: Treadmill
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults
Time Frame: three months
Measuring Blood pressure before and after the all program
three months
Influence of surgical mask on Resting and post exercise heart rate during controlled endurance exercise in sedentary adults
Time Frame: three months
Measuring Resting and post exercise heart rate before and after the all program
three months
Influence of surgical mask on resting and post exercise respiratory rate during controlled endurance exercise in sedentary adults
Time Frame: three months
Measuring resting and post exercise respiratory rate before and after the all program
three months
Influence of surgical mask on oxygen saturation, maximum oxygen consumption during controlled endurance exercise in sedentary adults
Time Frame: three months
Measuring oxygen saturation, maximum oxygen consumption before and after the all program
three months
Influence of surgical mask on quality of life during controlled endurance exercise in sedentary adults
Time Frame: three months
quality of life will be measured using short form quality of life 36 questionnaire, with score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of surgical mask on rate of perceived exertion during controlled endurance exercise in sedentary adults
Time Frame: three months
rate of perceived exertion will be measured by Borg scale with score ranged from 6-20 before and after intervention.
three months
Influence of surgical mask on submaximal exercise capacity during controlled endurance
Time Frame: three months
submaximal exercise capacity will be detected by six-minutes walking test and the distance which will be obtained will be measured by meter before and after the all program
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Rana H El Banna, PHD, Outpatient clinic faculty of physical therapy at Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

October 20, 2021

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Personal (Ain Shams)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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