- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Gedetailleerde beschrijving
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
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Rana H El Banna, PHD
- Telefoonnummer: 00201062070686
- E-mail: rana.elbanna@yahoo.com
Studie Contact Back-up
- Naam: Sherif O Elabd, master
- Telefoonnummer: 0096871174218
- E-mail: shiref.osama@yahoo.com
Studie Locaties
-
-
-
Giza, Egypte, 12613
- Werving
- Outpatient clinic faculty of physical therapy at Cairo University
-
Contact:
- Mohamed O Hesham, PHD
- Telefoonnummer: 00201067227404
- E-mail: shiref.elabd@yahoo.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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,)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Influence of surgical mask on rate of perceived exertion during controlled endurance exercise in sedentary adults
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rana H El Banna, PHD, Outpatient clinic faculty of physical therapy at Cairo University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Personal (Ain Shams)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .