Endurance Training in Patients With Post-TB Lung Disease
Primary Purpose
Tuberculosis, Post-Tuberculous Pleural Fibrosis, Post-Tuberculous Bronchiectasis
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental
Control
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring Endurance training, Functional Capacity, Post-TB lung disease, Quality of Life
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Smoker, Diabetes, and cardiac patients Physical disabled, pregnant (lactating women) Sputum + testing for TB Gene expert CVD (unstable) Not willing to participate
Sites / Locations
- Green Star NGORecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interventional
Control
Arm Description
Aerobic and respiratory endurance exercises with patient education
Usual care (Patient Education, Home Plan)
Outcomes
Primary Outcome Measures
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.
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.
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
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06047795
First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT06047795
Brief Title
Endurance Training in Patients With Post-TB Lung Disease
Official Title
Effect of Endurance Training On Functional Capacity and Quality of Life in Patients With Post-TB Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Post-Tuberculous Pleural Fibrosis, Post-Tuberculous Bronchiectasis
Keywords
Endurance training, Functional Capacity, Post-TB lung disease, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Aerobic and respiratory endurance exercises with patient education
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Usual care (Patient Education, Home Plan)
Intervention Type
Other
Intervention Name(s)
Experimental
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional capacity
Description
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.
Time Frame
3 weeks, 6 weeks
Title
Dyspnea
Description
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.
Time Frame
3 weeks, 6 weeks
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Time Frame
3 weeks,6 weeks
Title
Forced vital Capacity (FVC)
Description
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Time Frame
3 weeks,6 weeks
Title
Peak Expiratory Flow (PEF)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Time Frame
3 weeks,6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Smoker, Diabetes, and cardiac patients
Physical disabled, pregnant (lactating women)
Sputum + testing for TB
Gene expert
CVD (unstable)
Not willing to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehwish Waseem, MSPT-CPPT
Phone
0331-5309015
Email
mehwish.waseem@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT-CPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Green Star NGO
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT-CPPT
Phone
0331-5309015
Email
mehwish.waseem@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Safa Marwa, MSPT-CPPT*
Phone
0311-9069579
Email
marwasafa258@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Endurance Training in Patients With Post-TB Lung Disease
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