An interventional study of Intervention Group and control group in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Federal University of Health Science of Porto Alegre. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Treatment
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.
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Federal University of Health Science of Porto Alegre is the lead sponsor of 119 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
This arm will emit light.
Other: Intervention Group
This arm will be the placebo, where there will be no light emission.
Other: control group
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.
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.
Functional capacity
Functional capacity will be assessed by the number of steps per unit of time, using the six-minute step test (6MST).
Time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).
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.
Time frame: 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).
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
Time frame: 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).
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
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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).
Time frame: 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).
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).
Time frame: 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).
Inspiratory muscle strength
Inspiratory muscle strength will be measured by maximum inspiratory pressure (MIP) using the digital manovacuometer device.
Time frame: Baseline (Day 0) and Week 8 (after 16 intervention sessions).
Expiratory muscle strength
Expiratory muscle strength will be measured by maximum inspiratory pressure (MEP) using the digital manovacuometer device.
Time frame: Baseline (Day 0) and Week 8 (after 16 intervention sessions).
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.
Time frame: Baseline (Day 0) and Week 8 (after 16 intervention sessions).
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.
Time frame: Baseline (Day 0) and Week 8 (after 16 intervention sessions).
Muscle damage
Muscle damage will be assessed through serum creatine kinase (CK) levels, measured via spectrophotometry using automated equipment.
Time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).
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.
Time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).
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.
Time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).
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.
Time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).
Isometric quadriceps muscle strength
Isometric quadriceps muscle strength will be assessed using the assessment of quadriceps isometric strength with a portable dynamometer.
Time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).
Lower limb muscle strength
Assessment of lower limb strength will be carried out using the 10-repetition sit-and-stand test (TSL10).
Time frame: Baseline (Day 0), Week 4 (after 8 intervention sessions), and Week 8 (after 16 intervention sessions).
Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 0 months is below that.
Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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 ↗
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