Lung Function DecreasedPhase 1NCT06070584
Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt
A Phase 1 study testing aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., in people with Lung Function Decreased, run by Deraya University at 1 site in Egypt.
Trial summary
forty quarry workers participated in the study with age range (40-60 years), body mass index (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two groups randomly. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Function Decreased
- What is being tested?
- aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2023to 2 Oct 2023
- Phase
- Phase 1
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- quarry workers working in the quarries for five years ago at least saver from chest diseases\\
- BMI ranged from 25 to 34.9 kg/cm2
Who cannot join
- Subject with infected chest disease, unstable mental condition and chest cancer patients
- musculoskeletal disease
Trial locations and contacts
1 site in 1 country.
About this study
forty quarry workers participated in the study with age range (40-60 years), body mass index (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two groups randomly. (Group A) received aerobic exercises (Group B) receive aerobic exercises with moderate intensity in the form of walking on electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., 3 sessions per week for 8 consecutive weeks. Pulmonary function test was applied by spirometry to assess lung function
- Conditions
- Lung Function Decreased
- Being tested
- aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,Procedure or surgery
aerobic exercises with moderate intensity in the form of walking on electrical treadmill
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | received aerobic exercises only Receives: Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., |
| Group B | Experimental | aerobic exercises with moderate intensity in the form of walking on electrical treadmill Receives: Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate lung function
Spirometer test, The patient was instructed to take a big breath in and then exhale as forcefully and quickly as they could, continuing until there was no more air remaining, in order to measure FVC and FEV1
Measured: 8 weeks
patient satisfaction
VAS scoring, (no pain=0) and the other end (worst pain=10).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start2 Jan 2023
- Primary completion2 May 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Function DecreasedStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070584
- Sponsor's protocol ID
- 4/23
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt
- ClinicalTrials.gov ID
- NCT06070584
- Acronym / sponsor ID
- 4/23
- Conditions
- Lung Function Decreased
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 6 Oct 2023 (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.
forty quarry workers participated in the study with age range (40-60 years), body mass index (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two groups randomly. (Group A) received aerobic exercises (Group B) receive aerobic exercises with moderate intensity in the form of walking on electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., 3 sessions per week for 8 consecutive weeks. Pulmonary function test was applied by spirometry to assess lung function
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,received aerobic exercises only |
| Group B | Experimental | Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,aerobic exercises with moderate intensity in the form of walking on electrical treadmill |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- quarry workers working in the quarries for five years ago at least saver from chest diseases\\
- BMI ranged from 25 to 34.9 kg/cm2
Key exclusion criteria (2 listed)
- Subject with infected chest disease, unstable mental condition and chest cancer patients
- musculoskeletal disease
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 |
|---|---|---|
| aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,aerobic exercises with moderate intensity in the form of walking on electrical treadmill | Procedure or surgery | Group B, group A |
Primary outcome
adequate lung function
Time frame: 8 weeks
Spirometer test, The patient was instructed to take a big breath in and then exhale as forcefully and quickly as they could, continuing until there was no more air remaining, in order to measure FVC and FEV1
patient satisfaction
Time frame: 8 weeks
VAS scoring, (no pain=0) and the other end (worst pain=10).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., in people with Lung Function Decreased, run by Deraya 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Nov 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate lung function (time frame: 8 weeks). The study lists 2 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 7 Nov 2023.