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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05004480
Other study ID # Personal
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 14, 2021
Est. completion date October 20, 2021

Study information

Verified date August 2021
Source Cairo University
Contact Rana H El Banna, PHD
Phone 00201062070686
Email rana.elbanna@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 20, 2021
Est. primary completion date September 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Treadmill
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms

Locations

Country Name City State
Egypt Outpatient clinic faculty of physical therapy at Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults Measuring Blood pressure before and after the all program three months
Primary Influence of surgical mask on Resting and post exercise heart rate during controlled endurance exercise in sedentary adults Measuring Resting and post exercise heart rate before and after the all program three months
Primary Influence of surgical mask on resting and post exercise respiratory rate during controlled endurance exercise in sedentary adults Measuring resting and post exercise respiratory rate before and after the all program three months
Primary Influence of surgical mask on oxygen saturation, maximum oxygen consumption during controlled endurance exercise in sedentary adults Measuring oxygen saturation, maximum oxygen consumption before and after the all program three months
Primary Influence of surgical mask on quality of life during controlled endurance exercise in sedentary adults 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 Influence of surgical mask on rate of perceived exertion during controlled endurance exercise in sedentary adults rate of perceived exertion will be measured by Borg scale with score ranged from 6-20 before and after intervention. three months
Secondary Influence of surgical mask on submaximal exercise capacity during controlled endurance 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
See also
  Status Clinical Trial Phase
Completed NCT00281437 - Health First-Study 2 Phase 2/Phase 3