- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05004480
Influence of Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults
Influence of Surgical Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults
Studieoversigt
Detaljeret beskrivelse
Group (A):
- Each subject will sign a consent form after receiving a detailed explanation about the procedure.
- Functional capacity and Quality of life will be evaluated before the start of the training.
- 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):
- Each subject will sign a consent form after receiving a detailed explanation about the procedure.
- Functional capacity and Quality of life will be evaluated before the start of the training.
- 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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Rana H El Banna, PHD
- Telefonnummer: 00201062070686
- E-mail: rana.elbanna@yahoo.com
Undersøgelse Kontakt Backup
- Navn: Sherif O Elabd, master
- Telefonnummer: 0096871174218
- E-mail: shiref.osama@yahoo.com
Studiesteder
-
-
-
Giza, Egypten, 12613
- Rekruttering
- Outpatient clinic faculty of physical therapy at Cairo University
-
Kontakt:
- Mohamed O Hesham, PHD
- Telefonnummer: 00201067227404
- E-mail: shiref.elabd@yahoo.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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,)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Surgical Mask Group
participants of both sexes who will perform controlled endurance exercise on treadmill while wearing surgical mask
|
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
|
|
Eksperimentel: Non mask Group
participants of both sexes who will perform controlled endurance exercise on treadmill without wearing surgical mask
|
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Influence of surgical mask on rate of perceived exertion during controlled endurance exercise in sedentary adults
Tidsramme: three months
|
rate of perceived exertion will be measured by Borg scale with score ranged from 6-20 before and after intervention.
|
three months
|
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Influence of surgical mask on submaximal exercise capacity during controlled endurance
Tidsramme: 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
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three months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Rana H El Banna, PHD, Outpatient clinic faculty of physical therapy at Cairo University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Personal (Ain Shams)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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