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Chronic Obstructive Pulmonary Disease (COPD)NCT07878884

PBMT Associated With a Pulmonary Rehabilitation Program on the Functional Capacity of Patients With COPD

A study testing Intervention Group in people with Chronic Obstructive Pulmonary Disease (COPD), run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the effectiveness of photobiomodulation therapy (PBMT) as an adjunct to the pulmonary rehabilitation program on the functional capacity of patients with COPD. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
Intervention Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteBrazil
Study dates
1 Oct 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with COPD, in the maintenance phase, with GOLD classification 3 and 4;
  • Ability to walk.

Who cannot join

  • Cognitive dysfunction that prevents the completion of assessments, as well as inability to understand and sign the informed consent form (ICF);
  • Patients with sequelae of stroke;
  • Recent acute myocardial infarction (within two months);
  • Uncontrolled hypertension;
  • Heart failure grade IV according to the New York Heart Association or decompensated;
  • Unstable angina or arrhythmia;
Show all 13Show fewer
  • Peripheral vascular alterations in lower limbs such as deep vein thrombosis;
  • Disabling osteoarticular or musculoskeletal disease;
  • Patients with cancer and/or undergoing cancer treatment;
  • Patients with systemic lupus erythematosus;
  • Pacemaker or cardiac defibrillator;
  • Hemophilia;
  • Recent skin lesions or tattoos at the site of therapy application.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jociane J Schardong, PHD contact

+55 (51) 981348114

jocianeschardong@gmail.com

Brazil1 site, 1 recruiting
  • Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

    Jociane J Schardong, PHD, +55 (51) 981348114, jocianeschardong@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Photobiomodulation Therapy (PBMT) Associated With a Pulmonary Rehabilitation Program on the Functional Capacity of Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized, Placebo-controlled, Double-blind Clinical Trial.

This study aims to evaluate the effectiveness of photobiomodulation therapy (PBMT) as an adjunct to the pulmonary rehabilitation program on the functional capacity of patients with COPD. This is a randomized, placebo-controlled, double-blind clinical trial conducted with 20 patients from the outpatient clinic of the Integrated Cardiopulmonary and Metabolic Rehabilitation Service of Santa Casa de Porto Alegre. Patients will be allocated to the active PBMT group, receiving photobiomodulation treatment prior to the exercise protocol of the pulmonary rehabilitation program, in the respiratory and peripheral muscles, or the placebo group, which will receive the therapy application at the same points but without the therapeutic dose, prior to rehabilitation. Sixteen PBMT applications will be performed over eight weeks, with a frequency of twice a week. The exercises performed in the institution's pulmonary rehabilitation program by the patients will not be interfered with by the researchers. Evaluations will be carried out in three stages: immediately after recruitment, after 8 interventions, and after 16 interventions.

Read the detailed description

Chronic obstructive pulmonary disease (COPD) is a global health problem and the third leading cause of death worldwide. It is characterized by chronic inflammation and remodeling of the airways, inflammation and destruction of the lung parenchyma, resulting in various pulmonary and extrapulmonary manifestations. Symptoms such as cough, mucus production, dyspnea, and fatigue are predominant clinical manifestations and limit the daily life activities of patients with COPD. Associated with this, sarcopenia and impaired functional capacity strongly impact the quality of life of this population and increase mortality rates.

In this sense, pulmonary rehabilitation programs, focusing on physical exercise, are widely validated as a non-pharmacological treatment to improve COPD symptoms and reduce hospitalizations due to complications of the disease. PBMT consists of the application of non-thermal radiation through low-intensity laser or light-emitting diode (LED), with the aim of stimulating or inhibiting cellular activity. The photons emitted by these devices are absorbed by photoreceptors, increasing the availability of cellular energy and promoting tissue repair, as well as anti-inflammatory and analgesic effects.

There is ample evidence highlighting the positive effects of PBMT on improving muscle performance and reducing fatigue in healthy individuals and athletes. Studies in populations with chronic diseases such as heart failure, chronic kidney disease, and COPD are still scarce in the literature, and the benefits of this therapy need to be further investigated.

It is hypothesized that PBMT may be an additional resource to pulmonary rehabilitation programs, facilitating exercise execution, reducing symptoms of dyspnea and fatigue, and improving long-term functional capacity, since these patients would have better performance during the training program.

Being tested
Intervention Group, control group
Keywords
Chronic Obstructive Pulmonary Disease, Low-Level Light Therapy, Randomized Controlled Clinical Trial
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupOther

    Will be calibrated Multi Radience Medical® MR5 ACTIV PRO LaserShower superpulsed laser will be used. Will be applied twice a week for eight weeks to the lower limbs and respiratory muscles. In the lower limb, the following will be irradiated: the quadriceps muscle (4 points), the hamstring muscles (3 points), and the gastrocnemius (1 point), bilaterally. Among the respiratory muscles, the diaphragm (6 points) and the sternocleidomastoid (1 point - bilaterally) will be irradiated. In total, the application will be done at 24 points. The energy transmitted to the patient (dose) will be 30J per application point, through a cluster with four wavelengths (905, 850, 630 and 470 nm), with a frequency of 250hz and a peak pulse power of 200 mW. Considering that each application point receives 30J, the knee extensors are solicited around 240J, the knee flexors and diaphragm 180J, the ankle flexors 60J and the sternocleidomastoid 60J.

  • control groupOther

    For the application of placebo PBMT, the patient will be instructed to lie on their back and then on their side, and the properly calibrated Multi Radience Medical® MR5 ACTIV PRO LaserShower superpulsed laser will be used. The treatment will be performed with the beam in contact with the skin at a 90º angle. The therapy will be applied twice a week for eight weeks to the lower limbs and respiratory muscles. In the lower limb, the following will be irradiated: the quadriceps muscle (four points), the hamstring muscles (three points), and the gastrocnemius (one point), bilaterally. Among the respiratory muscles, the diaphragm (six points) and the sternocleidomastoid (one point - bilaterally) will be irradiated. In total, the application will be done at 24 points.

    In this group, the dose will not be released, however, patients identified the same audible and visual signals, as well as the duration of the device's contact with the skin, as in the treated group.

Study groups in NCT07878884
Study groupRoleWhat they receive
PBMT (photobiomodulation)ExperimentalThis arm will emit light.
Receives: Other: Intervention Group
Placebo PBMT (no - photobiomodulation)Placebo comparatorThis arm will be the placebo, where there will be no light emission.
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional capacity

    Functional capacity will be assessed by the number of steps per unit of time, using the six-minute step test (6MST).

    Measured: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

Secondary outcomes (17)
  1. Peripheral oxygen saturation

    Peripheral oxygen saturation will be assessed by pulse oximetry at the beginning of the tests (T0) and immediately (T1) after completing the sit-to-stand and 6-minute step tests.

    Measured: Assessment will be conducted before and immediately after the functional capacity. Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  2. Respiratory rate

    Respiratory rate will be assessed by visual measurement of respiratory excursions at the beginning of the tests (T0) and immediately (T1) after completing the sit-to-stand and 6-minute step tests

    Measured: Assessment will be conducted before and immediately after the functional capacity. Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  3. Heart rate

    Heart rate will be measured by pulse oximetry at the beginning of the tests (T0) and immediately (T1) after completing the sit-to-stand and 6-minute step tests

    Measured: Assessment will be conducted before and immediately after the functional capacity. Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  4. Systolic blood pressure

    Systolic blood pressure will be measured using a sphygmomanometer at the beginning of the tests (T0) and immediately (T1) after completing the sit-to-stand and 6-minute step tests.

    Measured: Assessment will be conducted before and immediately after the functional capacity. Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  5. Diastolic blood pressure

    Diastolic blood pressure will be measured using a sphygmomanometer at the beginning of the tests (T0) and immediately (T1) after completing the sit-to-stand and 6-minute step tests.

    Measured: Assessment will be conducted before and immediately after the functional capacity. Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  6. Muscle pain

    Muscle pain will also be measured with the Numerical Pain Scale at the beginning of the tests (T0) and immediately (T1) after completing the sit-to-stand and 6-minute step tests. This scale classifies pain from 0 (not at all) to 10 (maximum).

    Measured: Assessment will be conducted before and immediately after the functional capacity. Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  7. Perceived exertion

    Perceived exertion will also be measured with the Numerical Pain Scale at the beginning of the tests (T0) and immediately (T1) after completing the sit-to-stand and 6-minute step tests. This scale classifies pain from 0 (not at all) to 10 (maximum).

    Measured: Assessment will be conducted before and immediately after the functional capacity. Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  8. Inspiratory muscle strength

    Inspiratory muscle strength will be measured by maximum inspiratory pressure (MIP) using the digital manovacuometer device.

    Measured: Baseline (Day 0) and Week 8 (after 16 intervention sessions).

  9. Expiratory muscle strength

    Expiratory muscle strength will be measured by maximum inspiratory pressure (MEP) using the digital manovacuometer device.

    Measured: Baseline (Day 0) and Week 8 (after 16 intervention sessions).

  10. Muscle thickness of the lateralis vastus

    The muscle thickness will be evaluated for the acquisition of ultrasound images of the lateralis vastus using a high-resolution ultrasound device.

    Measured: Baseline (Day 0) and Week 8 (after 16 intervention sessions).

  11. Muscle thickness of the rectus femoris

    The muscle thickness will be evaluated for the acquisition of ultrasound images of the rectus femoris using a high-resolution ultrasound device.

    Measured: Baseline (Day 0) and Week 8 (after 16 intervention sessions).

  12. Muscle damage

    Muscle damage will be assessed through serum creatine kinase (CK) levels, measured via spectrophotometry using automated equipment.

    Measured: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  13. Interleukin 10

    Interleukin 10 will be analyzed, after blood collection, measured by enzyme-linked immunosorbent assay (ELISA), which will be performed after completion of all tests.

    Measured: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  14. Interleukin 6

    Interleukin 6 will be analyzed, after blood collection, measured by enzyme-linked immunosorbent assay (ELISA), which will be performed after completion of all tests.

    Measured: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  15. Tumor necrosis factor alpha (TNF-α )

    Tumor necrosis factor alpha will be analyzed, after blood collection, measured by enzyme-linked immunosorbent assay (ELISA), which will be performed after completion of all tests.

    Measured: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  16. Isometric quadriceps muscle strength

    Isometric quadriceps muscle strength will be assessed using the assessment of quadriceps isometric strength with a portable dynamometer.

    Measured: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

  17. Lower limb muscle strength

    Assessment of lower limb strength will be carried out using the 10-repetition sit-and-stand test (TSL10).

    Measured: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion26 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Model description
Parallel Assignment
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07878884
Sponsor's protocol ID
Photomodulation_COPD
Status last verified
Oct 2026
First submitted
2 Jul 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Chronic Obstructive Pulmonary Disease (COPD), run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

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 2 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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 Brazil. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jociane J Schardong, PHD (+55 (51) 981348114, jocianeschardong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional capacity (time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).). 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 16 Oct 2026.

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