- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03821285
Respiratory Function in Patients With Post-tuberculosis Lung Impairment
Evaluation of Respiratory Function in Patients With Post-tuberculosis Lung Impairment After Pulmonary Tuberculosis Treatment or After Spontaneous Healing
Study Overview
Status
Intervention / Treatment
Detailed Description
Methods Respiratory functional parameters at baseline and at the end of the 15 sessions rehabilitation programme (RP) will be collected at the participating Centre. Follow-up visit 1 year after completion of RP Baseline assessment
- After signature of the informed consent to the study, patients will undergo a Pre-screening Visit: data on medical history, current pharmacological therapies, smoking (pack/year), vaccinations, physical examination, vital parameters (blood pressure, heart rate, respiratory rate, oxygen saturation in arterial blood), co-morbidities and Mini Mental State Examination will be collected.
- Screening Visit (before the RP), during the visit the following data will be collected: number of TB disease episodes, detailed data on the last TB episode (age at onset of TB symptoms, age at TB diagnosis, anti-TB treatment duration, anti-TB drugs administered, socio-economic conditions, education level, physical examination, vital parameters, oxygen saturation in arterial blood, heart rate and respiratory rate). Pulmonary rehabilitation program tailored according to specific patient's needs.
- Baseline assessment of respiratory function: arterial blood gas (ABG) analysis, spirometry, diffusing capacity of the lungs for carbon monoxide (DLCO), overnight oximetry, electrocardiogram (ECG), chest X-ray (CXR), High-resolution computed tomography (HRCT)
- Assessment of the rehabilitation programme: functional evaluation (6MWT), muscle strength evaluation (five-repetition sit-to-stand test (5STS)), respiratory muscle strength (maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)), symptoms evaluation (Dyspnea: Medical Research Council Questionnaire (MRC), Modified Borg pre/post 6MWT, Baseline and Transition Dyspnea Indexes (BDI-TDI) and Fatigue: Modified Borg pre/post 6MWT)
- Assessment of the Quality of Life (QoL): CAT and St George's Respiratory Questionnaire.
Final assessment:
A final assessment will be done at the end of the rehabilitation programme and will include:
c) Only ABG, spirometry and DLCO d) and e).
Pulmonary rehabilitation programme
PR programme will include:
At least 15 aerobic-training sessions by cycle ergometer supervised by a respiratory therapist (5 session per week, 30 minutes each: 5 minutes warm up, 20 minutes training and 5 minutes warm-down) at constant load (calculated with Hill equation, Hill K, et al. Estimating maximum work rate during incremental cycle ergometry testing from six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2008;89(9):1782-7.) with an adherence of at least 80%.
- At least 15 strength-training sessions for peripheral muscles (30 minutes calisthenics exercise) with an adherence of at least 80%.
At least 3 face to face and/or group educational sessions, for:
- Optimization of inhalation techniques
- Exercise training and maintenance programs
- Daily physical activity
- Airways clearance techniques
- Long oxygen therapy home management.
According to individual needs, the PR program should include:
- airways clearance techniques
- inspiratory muscles training (with Threshold®)
Monitoring Anonymous data will be collected in a common electronic format (excel database).
Adverse events (AEs) and severe adverse events (SAEs) will be reported and registered.
Follow-up
Follow-up visit 1 year after completion of RP will include:
c) Only ABG, spirometry, DLCO and overnight oximetry d) and e) Statistical analysis A two-tailed p-value less than 0.05 will be considered statistically significant.
Qualitative and quantitative variables will be described with absolute and relative (percentages) frequencies and means (standard deviations -SD) or medians (interquartile ranges -IQR) depending on their normality, respectively. The mean difference between the two study groups in the 6MWT will be evaluated using the Student's t-test. Differences in the variables associated to the secondary objectives will be evaluated using the Chi-square or Student's t-test for qualitative and quantitative variables. A two-tailed p-value less than 0.05 will be considered statistically significant.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dina Visca, Dr
- Phone Number: +390331829111
- Email: dina.visca@icsmaugeri.it
Study Contact Backup
- Name: Elisabetta Zampogna, Dr
- Phone Number: +390331829503
- Email: elisabetta.zampogna@icsmaugeri.it
Study Locations
-
-
Varese
-
Tradate, Varese, Italy, 21049
- Recruiting
- ICS Maugeri, IRCCS
-
Contact:
- Dina Visca, Dr
- Phone Number: +390331829111
- Email: dina.visca@icsmaugeri.it
-
Contact:
- Elisabetta Zampogna, Dr
- Phone Number: +390331829503
- Email: elisabetta.zampogna@icsmaugeri.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with post-TB lung impairment after completion of pulmonary tuberculosis treatment - Patients with post- TB impairment after spontaneous healing
Exclusion Criteria:
- Any unstable medical condition
- Musculoskeletal disorders contraindicating participation in the PR program
- Cognitive impairment (Mini Mental State Examination <22)
- Unable to sign informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pulmonary rehabilitation
Pulmonary rehabilitation program
|
Pulmonary rehabilitation programme:15 aerobic-training sessions, 15 strength-training sessions for peripheral muscles, 3 face to face and/or Group educational sessions, if needed airways clearance techniques and/or inspiratory muscles training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-min walking test
Time Frame: 1 year
|
Exercise capacity
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dyspnoea
Time Frame: 1 year
|
Modified BORG scale (0-10) 0 better, 10 worse
|
1 year
|
muscle fatigue
Time Frame: 1 year
|
Modified Borg scale (0-10) 0 better, 10 worse
|
1 year
|
health related quality of life
Time Frame: 1 year
|
st. George Respiratory Questionnaire 0 better, 100 worse
|
1 year
|
health status
Time Frame: 1 year
|
COPD Assessment test-CAT (0-40) 0 better, 40 worse
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Giovan Battista Migliori, Prof, ICS Maugeri, IRCCS
Publications and helpful links
General Publications
- Tiberi S, Munoz-Torrico M, Duarte R, Dalcolmo M, D'Ambrosio L, Migliori GB. New drugs and perspectives for new anti-tuberculosis regimens. Pulmonology. 2018 Mar-Apr;24(2):86-98. doi: 10.1016/j.rppnen.2017.10.009. Epub 2018 Feb 24.
- Munoz-Torrico M, Rendon A, Centis R, D'Ambrosio L, Fuentes Z, Torres-Duque C, Mello F, Dalcolmo M, Perez-Padilla R, Spanevello A, Migliori GB. Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis? J Bras Pneumol. 2016 Sep-Oct;42(5):374-385. doi: 10.1590/S1806-37562016000000226.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2215CE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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