- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rana H El Banna, PHD
- Numéro de téléphone: 00201062070686
- E-mail: rana.elbanna@yahoo.com
Sauvegarde des contacts de l'étude
- Nom: Sherif O Elabd, master
- Numéro de téléphone: 0096871174218
- E-mail: shiref.osama@yahoo.com
Lieux d'étude
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Giza, Egypte, 12613
- Recrutement
- Outpatient clinic faculty of physical therapy at Cairo University
-
Contact:
- Mohamed O Hesham, PHD
- Numéro de téléphone: 00201067227404
- E-mail: shiref.elabd@yahoo.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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,)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Influence of surgical mask on rate of perceived exertion during controlled endurance exercise in sedentary adults
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rana H El Banna, PHD, Outpatient clinic faculty of physical therapy at Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Personal (Ain Shams)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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