Sedentary AdultsNCT05004480
Influence of Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults
A study testing Treadmill in people with Sedentary Adults, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Adults
- What is being tested?
- Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2021to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 100 participants
- 30 to 40 years of age
- both sex
Who cannot join
- uncontrolled cardiopulmonary conditions,
- sever un treated orthopedic condition
- uncontrolled neurological conditions,)
- uncontrolled diabetes,
- claustrophobia,
- pregnancy
- Recent COVID-19 infection,)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic faculty of physical therapy at Cairo University
Giza, 12613
Mohamed O Hesham, PHD, 00201067227404, shiref.elabd@yahoo.com
About this study
Official title: Influence of Surgical Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults
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
Read the detailed description
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.
- Conditions
- Sedentary Adults
- Being tested
- Treadmill
- Keywords
- Surgical mask, Functional capacity, Quality of life, Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmillDevice
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
| Study group | Role | What they receive |
|---|---|---|
| Surgical Mask Group | Experimental | participants of both sexes who will perform controlled endurance exercise on treadmill while wearing surgical mask Receives: Device: Treadmill |
| Non mask Group | Experimental | participants of both sexes who will perform controlled endurance exercise on treadmill without wearing surgical mask Receives: Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults
Measuring Blood pressure before and after the all program
Measured: three months
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
Measured: three months
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
Measured: three months
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
Measured: three months
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.
Measured: three months
Secondary outcomes (2)
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.
Measured: three months
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
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start14 Jun 2021
- Primary completion15 Sep 2021 (estimated)
- Study completion20 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary AdultsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elbanna, Cairo University
- Investigators
- Rana H El Banna, PHD, Principal investigator, Outpatient clinic faculty of physical therapy at Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004480
- Sponsor's protocol ID
- Personal
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Surgical Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults
- ClinicalTrials.gov ID
- NCT05004480
- Acronym / sponsor ID
- Personal
- Conditions
- Sedentary Adults
- Keywords
- Surgical mask, Functional capacity, Quality of life, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Surgical Mask Group | Experimental | Device: Treadmillparticipants of both sexes who will perform controlled endurance exercise on treadmill while wearing surgical mask |
| Non mask Group | Experimental | Device: Treadmillparticipants of both sexes who will perform controlled endurance exercise on treadmill without wearing surgical mask |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 100 participants
- 30 to 40 years of age
- both sex
Key exclusion criteria (7 listed)
- uncontrolled cardiopulmonary conditions,
- sever un treated orthopedic condition
- uncontrolled neurological conditions,)
- uncontrolled diabetes,
- claustrophobia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreadmillElectronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms | Device | Non mask Group, Surgical Mask Group |
Primary outcome
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults
Time frame: three months
Measuring Blood pressure before and after the all program
Influence of surgical mask on Resting and post exercise heart rate during controlled endurance exercise in sedentary adults
Time frame: three months
Measuring Resting and post exercise heart rate before and after the all program
Influence of surgical mask on resting and post exercise respiratory rate during controlled endurance exercise in sedentary adults
Time frame: three months
Measuring resting and post exercise respiratory rate before and after the all program
Influence of surgical mask on oxygen saturation, maximum oxygen consumption during controlled endurance exercise in sedentary adults
Time frame: three months
Measuring oxygen saturation, maximum oxygen consumption before and after the all program
Influence of surgical mask on quality of life during controlled endurance exercise in sedentary adults
Time frame: 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.
2 secondary outcomes
Influence of surgical mask on rate of perceived exertion during controlled endurance exercise in sedentary adults
Time frame: three months
Influence of surgical mask on submaximal exercise capacity during controlled endurance
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana H El Banna, PHD principal investigator
Outpatient clinic faculty of physical therapy at Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill in people with Sedentary Adults, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana H El Banna, PHD (00201062070686, rana.elbanna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults (time frame: three months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.