NCT05047497

Brief Summary

Thousands of people are working daily in a dusty environment. Many studied reported respiratory symptoms and ventilatory disorders among Factory workers who exposed to cement dust. But the evidence for respiratory effect and daily activities over a long time of cement dust exposure has not been conclusive

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

September 4, 2020

Last Update Submit

September 11, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • The ventilatory functions

    ventilatory function tests were used to assess FVC (%), FEV1/FVC (%),PEF (%), FEV1 (%)

    8 months

  • oxygen saturation

    measuring oxygen saturation using SPo2

    8 months

  • quality of life were assessed

    the mean values of the physical functioning item and energy/fatigue item in the quality of life questionnaire

    8 months

Study Arms (3)

less than 10 years working

workers who work in cement factories in a period of time less than 10 years

Diagnostic Test: questionaire and ventilatory function test

from 10-15 years working

workers who work in cement factories in a period of time from 10-15 years

Diagnostic Test: questionaire and ventilatory function test

more than 15 years working

workers who work in cement factories in a period of time more than 15 years

Diagnostic Test: questionaire and ventilatory function test

Interventions

we assessed the arterial blood gases and the ventilatory functions and quality of life of whole three groups

from 10-15 years workingless than 10 years workingmore than 15 years working

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Out of sixty persons who were assigned to this study, a total of 49 subjects (group 1 n = 18, group 2 n = 13 and group 3 n = 18) completed the study (Fig. 1). In all groups, A, B and, C; height and weight scale were obtained for calculating BMI. The distribution of smokers between different age groups was measured (table ) The pulmonary function tests were performed to evaluate the capacity and volume of the lungs among the participants. Spirometry measurements, including FVC, FEV1, ratio of FEV1 to FVC (FEV1/FVC), forced expiratory flow 25-75% (FEF 25-75%), and peak expiratory flow (PEF

You may qualify if:

  • The ages were between 25 to 50 years old.
  • the body mass index ranged from (18,5 - 29,9) kg/m2.

You may not qualify if:

  • Age less than 25 or more 50.
  • Any chronic diseases
  • severe musculoskeletal and cardiopulmonary disorders and
  • Class III Obesity (35-39.9 kg/m 2) or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Occupational Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 17, 2021

Study Start

May 1, 2018

Primary Completion

March 5, 2019

Study Completion

May 29, 2019

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations