TuberculosisNCT06047795
Endurance Training in Patients With Post-TB Lung Disease
A study testing Experimental in people with Tuberculosis and Post-Tuberculous Pleural Fibrosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of endurance training on functional capacity and QOL(Quality of life) in patients with post-TB (tuberculosis) lung disease. Post-tuberculosis lung disease is a major health concern nowadays. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tuberculosis, Post-Tuberculous Pleural Fibrosis, Post-Tuberculous Bronchiectasis
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Sep 2023to 30 Jun 2024
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- TB (diagnosed) with Completed TB course
- Dyspnea (with or without cough)
- Age (18-50yrs).
- After 3 months of AFB and gene expert (-)
- Decreased PFT predicted values
Who cannot join
- Smoker, Diabetes, and cardiac patients
- Physical disabled, pregnant (lactating women)
- Sputum + testing for TB
- Gene expert
- CVD (unstable)
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Endurance Training On Functional Capacity and Quality of Life in Patients With Post-TB Lung Disease
To determine the effects of endurance training on functional capacity and QOL(Quality of life) in patients with post-TB (tuberculosis) lung disease. Post-tuberculosis lung disease is a major health concern nowadays. There is limited evidence in the literature regarding the rehabilitation of patients with cured tuberculosis which leads to post-TB complications.
Read the detailed description
Adults with post-TB respiratory symptoms experience skeletal muscle weakness due to inactivity, systemic inflammation, and poor nutrition, which is frequently made worse by poverty. Such patients experience a vicious cycle that includes decreased body weight, increasing morbidity, and higher mortality. People with Chronic Respiratory Diseases frequently avoid exercise, which causes them to lose motivation and decondition. This cycle of decline continues. In Pakistan, there is no concept of pulmonary rehabilitation for TB patients. The current study will attempt to fill this literature gap and also promote the concept of pulmonary rehabilitation for post-tuberculosis patients in Pakistan.
- Being tested
- Experimental, Control
- Keywords
- Endurance training, Functional Capacity, Post-TB lung disease, Quality of Life
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Cycling 2 days per week with Borg dyspnea 4-6 level for 15-20 minutes/ day with 5 minutes warm-up and cool-down.
Strengthening exercises for upper limb muscles (pull-ups and biceps curls) and for lower limb muscles (sit-to-stand and step-up exercises) with 3 sets of 8-12 repetitions * 2 days per week.
Pursed Lip breathing exercise 3 sets of 5-10 repetitions for 6 weeks
ControlOther
Usual care: frontal chest radiographs, verbal advice to quit smoking, and reduce exposure to biomass smoke.
Spirometry to screen for airway diseases. Antibiotic and systemic glucocorticoid therapy.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Aerobic and respiratory endurance exercises with patient education Receives: Other: Experimental |
| Control | Placebo comparator | Usual care (Patient Education, Home Plan) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.
Measured: 3 weeks, 6 weeks
Dyspnea
Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through the BORG dyspnea scale. it uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea.
Measured: 3 weeks, 6 weeks
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Measured: 3 weeks,6 weeks
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Measured: 3 weeks,6 weeks
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Measured: 3 weeks,6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start11 Sep 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047795
- Sponsor's protocol ID
- Rec/01657 Safa Marwa
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endurance Training On Functional Capacity and Quality of Life in Patients With Post-TB Lung Disease
- ClinicalTrials.gov ID
- NCT06047795
- Acronym / sponsor ID
- Rec/01657 Safa Marwa
- Keywords
- Endurance training, Functional Capacity, Post-TB lung disease, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Sep 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.
To determine the effects of endurance training on functional capacity and QOL(Quality of life) in patients with post-TB (tuberculosis) lung disease. Post-tuberculosis lung disease is a major health concern nowadays. There is limited evidence in the literature regarding the rehabilitation of patients with cured tuberculosis which leads to post-TB complications.
Detailed description
Adults with post-TB respiratory symptoms experience skeletal muscle weakness due to inactivity, systemic inflammation, and poor nutrition, which is frequently made worse by poverty. Such patients experience a vicious cycle that includes decreased body weight, increasing morbidity, and higher mortality. People with Chronic Respiratory Diseases frequently avoid exercise, which causes them to lose motivation and decondition. This cycle of decline continues. In Pakistan, there is no concept of pulmonary rehabilitation for TB patients. The current study will attempt to fill this literature gap and also promote the concept of pulmonary rehabilitation for post-tuberculosis patients in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: ExperimentalAerobic and respiratory endurance exercises with patient education |
| Control | Placebo comparator | Other: ControlUsual care (Patient Education, Home Plan) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- TB (diagnosed) with Completed TB course
- Dyspnea (with or without cough)
- Age (18-50yrs).
- After 3 months of AFB and gene expert (-)
- Decreased PFT predicted values
Key exclusion criteria (6 listed)
- Smoker, Diabetes, and cardiac patients
- Physical disabled, pregnant (lactating women)
- Sputum + testing for TB
- Gene expert
- CVD (unstable)
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 |
|---|---|---|
| ExperimentalCycling 2 days per week with Borg dyspnea 4-6 level for 15-20 minutes/ day with 5 minutes warm-up and cool-down. Strengthening exercises for upper limb muscles (pull-ups and biceps curls) and for lower limb muscles (sit-to-stand and step-up exercises) with 3 sets of 8-12 repetitions * 2 days per week. Pursed Lip breathing exercise 3 sets of 5-10 repetitions for 6 weeks | Other | Interventional |
| ControlUsual care: frontal chest radiographs, verbal advice to quit smoking, and reduce exposure to biomass smoke. Spirometry to screen for airway diseases. Antibiotic and systemic glucocorticoid therapy. | Other | Control |
Primary outcome
Functional capacity
Time frame: 3 weeks, 6 weeks
Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.
Dyspnea
Time frame: 3 weeks, 6 weeks
Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through the BORG dyspnea scale. it uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 3 weeks,6 weeks
Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 3 weeks,6 weeks
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Peak Expiratory Flow (PEF)
Time frame: 3 weeks,6 weeks
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
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 4 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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.
Mehwish Waseem, MSPT-CPPT principal investigator
Riphah International 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 Experimental in people with Tuberculosis and Post-Tuberculous Pleural Fibrosis, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 6 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 4 Sep 2024. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Functional capacity (time frame: 3 weeks, 6 weeks). 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 4 Sep 2024.