- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Rana H El Banna, PHD
- Telefonnummer: 00201062070686
- E-post: rana.elbanna@yahoo.com
Studer Kontakt Backup
- Navn: Sherif O Elabd, master
- Telefonnummer: 0096871174218
- E-post: shiref.osama@yahoo.com
Studiesteder
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-
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Giza, Egypt, 12613
- Rekruttering
- Outpatient clinic faculty of physical therapy at Cairo University
-
Ta kontakt med:
- Mohamed O Hesham, PHD
- Telefonnummer: 00201067227404
- E-post: shiref.elabd@yahoo.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: Non mask Group
participants of both sexes who will perform controlled endurance exercise on treadmill without wearing surgical mask
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Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
three months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rana H El Banna, PHD, Outpatient clinic faculty of physical therapy at Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Personal (Ain Shams)
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