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Endurance Training in Patients With Post-TB Lung Disease

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06047795
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
5.7
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Experimental
  • Other: Control
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Endurance Training On Functional Capacity and Quality of Life in Patients With Post-TB Lung Disease
Actual Study Start Date :
Sep 11, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional

Aerobic and respiratory endurance exercises with patient education

Other: Experimental
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
Placebo Comparator: Control

Usual care (Patient Education, Home Plan)

Other: Control
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.

Outcome Measures

Primary Outcome Measures

  1. Functional capacity [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.

  2. Dyspnea [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.

  3. Forced Expiratory Volume in 1 second (FEV1) [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

  4. Forced vital Capacity (FVC) [3 weeks,6 weeks]

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

  5. Peak Expiratory Flow (PEF) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Green Star NGO Peshawar KPK Pakistan 25000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Mehwish Waseem, MSPT-CPPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT06047795
Other Study ID Numbers:
  • Rec/01657 Safa Marwa
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Endurance training
Functional Capacity
Post-TB lung disease
Quality of Life
Additional relevant MeSH terms:
Tuberculosis
Lung Diseases
Bronchiectasis

Study Results

No Results Posted as of Sep 21, 2023