ClinicalTrials.gg
CompletedNCT07925138Updated Nov 9, 2026

Single-session High-Intensity Laser Therapy in Pulmonary Tuberculosis

An interventional study of High-Intensity Laser Therapy (HILT) and Diaphragmatic Breathing Exercises in Tuberculosis, sponsored by RSUP Persahabatan. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by RSUP Persahabatan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2024, registered Nov 2026).
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

Pulmonary tuberculosis can result in impaired lung function and reduced functional capacity. This study evaluated the short-term effectiveness of High-Intensity Laser Therapy (HILT) combined with diaphragmatic breathing exercises in patients with drug-sensitive pulmonary tuberculosis during the continuation phase of treatment.

This single-blind, randomized, sham-controlled clinical trial included 36 participants assigned to an intervention group or a control group. The intervention group received one session of HILT combined with diaphragmatic breathing exercises, while the control group received sham laser treatment combined with the same breathing exercises.

Lung function and functional capacity were assessed using spirometry, peak expiratory flow, the six-minute walk test, and chest expansion measurements. Assessments were conducted at baseline and 24 hours after the intervention.

02

Conditions studied

  • Tuberculosis

Browse trials for

Keywords

  • tuberculosis
  • high-intensity laser therapy
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's enrollment of 36 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

RSUP Persahabatan is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-59 years.
  • of 18.5-24.9 kg/m² according to Asia-Pacific criteria.
  • Completion of the intensive phase of drug-sensitive pulmonary tuberculosis treatment with negative bacteriological conversion.
  • Pulmonary lesions consisting of nonspecific lesions, infiltrates, consolidation, or cavities.
  • Ability to understand and follow examination instructions.
  • Willingness to participate and provide written .

Exclusion criteria

Exclusion Criteria:

  • Unstable cardiovascular or respiratory conditions, including angina, arrhythmia, hemoptysis, and pneumothorax.
  • to HILT, including fever, pregnancy, tumors or cancer, and sensory deficits.
  • History of severe adverse reactions to anti-tuberculosis drugs during the intensive phase, such as drug-induced hepatitis.
  • conditions, including diseases and /AIDS.
  • Miliary tuberculosis or destroyed lung on radiological examination.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    High-Intensity Laser Therapy (HILT) Plus Diaphragmatic Breathing Exercises

    Participants received one session of High-Intensity Laser Therapy (HILT) using a BTL-6000 device (1064 nm wavelength, 5 W power, and 50 J/cm² energy density), combined with diaphragmatic breathing exercises.

    Device: High-Intensity Laser Therapy (HILT) · Behavioral: Diaphragmatic Breathing Exercises

  • Sham comparator
    Sham Laser Plus Diaphragmatic Breathing Exercises

    Participants received sham laser treatment using the BTL-6000 device, which emitted LED light without therapeutic laser emission, combined with diaphragmatic breathing exercises.

    Behavioral: Diaphragmatic Breathing Exercises · Device: Sham Laser

Interventions

  • DeviceHigh-Intensity Laser Therapy (HILT)

    High-Intensity Laser Therapy was administered using a BTL-6000 High Intensity Laser device at a wavelength of 1064 nm, in biostimulation mode, with a power of 5 W and an energy density of 50 J/cm². A single treatment session was performed, involving scanning over the pulmonary regions based on radiological findings, as well as the diaphragm and upper trapezius muscles.

  • BehavioralDiaphragmatic Breathing Exercises

    Participants performed diaphragmatic breathing exercises in the supine position, with one hand placed on the chest and the other on the abdomen. They were instructed to inhale slowly through the nose, emphasizing abdominal movement while minimizing chest movement. Each inhalation and exhalation lasted approximately six seconds, repeated for five cycles. The exercise was administered to both groups during the same treatment session.

  • DeviceSham Laser

    Sham laser treatment was administered using the BTL-6000 High Intensity Laser device. The device was switched on but emitted LED light only, without therapeutic laser emission. The procedure was used as a sham comparator in the control group.

06

What researchers measure

Primary outcomes

  1. Change in Six-Minute Walk Test Distance

    Time frame: Baseline to 24 hours post-intervention

Secondary outcomes

  1. Change in Forced Expiratory Volume in One Second (FEV1)

    Time frame: Baseline to 24 hours

  2. Change in Forced Vital Capacity (FVC)

    Time frame: Baseline to 24 hours

  3. Change in Peak Expiratory Flow (PEF)

    Time frame: Baseline to 24 hours

  4. Change in Chest Expansion

    Time frame: Baseline to 24 hours

07

Study locations

1 site
  • RS Persahabatan
    Jakarta, Jakarta Special Capital Region 13230, Indonesia
08

References and documents

Individual participant data

Plan to share: No — The investigators do not plan to make individual participant data (IPD) available to other researchers. This decision is based on participant confidentiality considerations and the provisions of the informed consent documents, which do not explicitly authorize external sharing of individual-level data. The study involves sensitive clinical information, and participant privacy will be maintained in accordance with the approved ethical requirements. Only aggregate research findings will be disseminated through scientific publications and presentations.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925138
Lead sponsor
RSUP Persahabatan
Collaborators
Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Jan 1, 2024
Primary completion
Apr 1, 2025
Completion
Dec 1, 2025
Last update
Nov 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion