NCT06047795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 14, 2023

Last Update Submit

September 2, 2024

Conditions

TuberculosisPost-Tuberculous Pleural FibrosisPost-Tuberculous Bronchiectasis

Keywords

Endurance trainingFunctional CapacityPost-TB lung diseaseQuality of Life

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    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

    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.

    3 weeks,6 weeks

Study Arms (2)

Interventional

EXPERIMENTAL

Aerobic and respiratory endurance exercises with patient education

Other: Experimental

Control

PLACEBO COMPARATOR

Usual care (Patient Education, Home Plan)

Other: Control

Interventions

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

Interventional
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.

Control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Smoker, Diabetes, and cardiac patients
  • Physical disabled, pregnant (lactating women)
  • Sputum + testing for TB
  • Gene expert
  • CVD (unstable)
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Green Star NGO

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Mehwish Waseem, MSPT-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

September 11, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)