LeukemiaNCT03876834
Respiratory Training in Patients With Leukemia
A study testing respiratory training in people with Leukemia, run by Cairo University at 1 site in Egypt.
Trial summary
Forty male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men only
- Conditions the study is for
- Leukemia
- What is being tested?
- respiratory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 30 Jun 2018
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male patient with age ranges from 30-50 years
- All patients were leukemic receiving chemotherapy for at least one cycle as a treatment of malignant tumor
- All patients were hemodynamically stable
- All patients were ambulant
Who cannot join
- lung cancer
- History of any pulmonary disease.
- Metastasis of lungs, ribs, mediastinal structure
- Pulmonary pathology(e.g acute respiratory distress syndrome or exacerbation of chronic obstructive pulmonary disease)
- ruptured ear drum or any other condition of the ear
- High peak airway pressure (barotraumas)
- patients with marked elevated left ventricular end diastolic volume and pressure
- patients with worsening heart failure signs and symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
Forty male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group.
The following measures were taken before and after the study period : Maximum voluntary ventilation(MVV) , 2 min walk test, FACT-G questionnaire
Read the detailed description
Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo ( inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly assigned into two groups.Group A (30 patients) who received inspiratory muscles training for 4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and Quality of life questionnaire (FACT-G) were statistically analyzed and compared
- Conditions
- Leukemia
- Being tested
- respiratory training
- Keywords
- leukemia, chemotherapy, respiratory training
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory trainingOther
Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)
| Study group | Role | What they receive |
|---|---|---|
| study group (group A) | Experimental | Group (A) included 30 leukemic patients receiving chemotherapy in addition to training by inspiratory muscle trainer(IMT) for 4 weeks, 5 sessions /week Receives: Other: respiratory training |
| control group (B) | No intervention | Group (B) included 10 leukemic patients receiving chemotherapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum voluntary ventilation
It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer
Measured: change from baseline maximum voluntary ventilation at 4 weeks
2 min walk test
Each patient was asked to cover as much ground as possible over 2 minutes
Measured: change from baseline 2 min walk test at 4 weeks
FACT-G questionnaire
27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing
Measured: change from baseline FACT-G questionnaire at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876834
- Sponsor's protocol ID
- 201617032.4
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
- ClinicalTrials.gov ID
- NCT03876834
- Acronym / sponsor ID
- 201617032.4
- Conditions
- Leukemia
- Keywords
- leukemia, chemotherapy, respiratory training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 15 Mar 2019 (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 male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group.
The following measures were taken before and after the study period : Maximum voluntary ventilation(MVV) , 2 min walk test, FACT-G questionnaire
Detailed description
Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo ( inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly assigned into two groups.Group A (30 patients) who received inspiratory muscles training for 4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and Quality of life questionnaire (FACT-G) were statistically analyzed and compared
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (group A) | Experimental | Other: respiratory trainingGroup (A) included 30 leukemic patients receiving chemotherapy in addition to training by inspiratory muscle trainer(IMT) for 4 weeks, 5 sessions /week |
| control group (B) | No intervention | –Group (B) included 10 leukemic patients receiving chemotherapy only |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male patient with age ranges from 30-50 years
- All patients were leukemic receiving chemotherapy for at least one cycle as a treatment of malignant tumor
- All patients were hemodynamically stable
- All patients were ambulant
Key exclusion criteria (8 listed)
- lung cancer
- History of any pulmonary disease.
- Metastasis of lungs, ribs, mediastinal structure
- Pulmonary pathology(e.g acute respiratory distress syndrome or exacerbation of chronic obstructive pulmonary disease)
- ruptured ear drum or any other condition of the ear
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 |
|---|---|---|
| respiratory trainingRespiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730) | Other | study group (group A) |
Primary outcome
Maximum voluntary ventilation
Time frame: change from baseline maximum voluntary ventilation at 4 weeks
It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer
2 min walk test
Time frame: change from baseline 2 min walk test at 4 weeks
Each patient was asked to cover as much ground as possible over 2 minutes
FACT-G questionnaire
Time frame: change from baseline FACT-G questionnaire at 4 weeks
27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing
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 15 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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 study testing respiratory training in people with Leukemia, 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 4 inclusion and 8 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 15 Mar 2019. 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?
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?
Maximum voluntary ventilation (time frame: change from baseline maximum voluntary ventilation at 4 weeks). The study lists 3 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 15 Mar 2019.