An interventional study of Multimodal training and IMT + Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease, sponsored by Universidade Federal de Santa Maria. Completed at 1 site in Brazil. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by Universidade Federal de Santa Maria · Not applicable, Interventional, and Treatment
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Among 144 studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil — 21 open to participants now, 24 under way, 7 of them phase 3. Pulmonary Disease, Chronic Obstructive · Brazil.
Among the 144 studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil, this one is the 73rd largest by enrollment of the 124 interventional ones that give a count, is one of 9 that started in 2019, is one of 64 with no phase, and was the 107th registered.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →21 of the 144 studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil are open now. Recruiting first, the newest first:
Federal University of Health Science of Porto Alegre · Sites in Brazil
Ages 18–90 · Healthy volunteers
Chiesi Farmaceutica Ltda. · Sites in Brazil
Ages 40+
Sanofi · Sites in Brazil, United States, Argentina and 19 more countries
Ages 40–85
Sanofi · Sites in Brazil, United States, Argentina and 23 more countries
Ages 40–80
Sanofi · Sites in Brazil, United States, Argentina and 22 more countries
Ages 40–80
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.
This study: 55 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
144 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 11 · Phase 3 36 · Phase 4 16
First in 2000; this study’s year is marked. 9 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 59 across the 124 interventional studies, 301 across the 20 observational. Of the 89 that completed or were terminated, 32 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
52 of 144 have an industry lead sponsor. The 10 most frequent:
Universidade Federal de Santa Maria is the lead sponsor of 37 studies on the registry; 2 are open to participants now.
Universidade Federal de Santa Maria has 1 study filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
6 of the studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05878769Phase 3Hoffmann-La RocheA Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) | 2027-06-30 |
| NCT07050823University College, LondonMitigating Chronic Respiratory Disease Through the Lens of Multi-Morbidity | 2026-12 |
| NCT07868211Júnea Regina Pires DrewsEffect of Dietary Fiber Supplementation on Systemic Inflammation and Clinical Parameters in COPD | 2027-04 |
| NCT07406048Chiesi Farmaceutica Ltda.Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients | 2027-06-30 |
| NCT07134855University College, LondonMitigating Chronic Respiratory Disease Through the Lens of Multimorbidity (MARES3) | 2027-07-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 144 studies in Pulmonary Disease, Chronic Obstructive with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Chronic obstructive pulmonary disease (COPD) is a significant current public health problem, characterized by the presence of limited airflow. However, COPD has important manifestations beyond the lungs, the so-called systemic effects. These included dysfunction of peripheral and respiratory muscles. The growing amount of evidence has shown that patients with COPD also present important deficits in postural balance and consequently, increased risk of falling. As an essential part of the management of COPD, pulmonary rehabilitation (PR) alleviates dyspnea and fatigue, improves exercise tolerance and health-related quality of life, and reduces hospital admissions and mortality for COPD patients. Exercise is the key component of PR, which is composed of exercise assessment and training therapy. Currently, two modalities of therapy have been suggested as complementary to pulmonary rehabilitation: inspiratory muscular training (IMT) and neuromuscular electrical stimulation (NMES). Based on the premise that peripheral and respiratory muscle dysfunction can negatively impact postural control of patients with COPD, and given the importance of balance as a modifiable risk factor for falls, it is important to investigate whether the use of these therapeutic modalities (IMT and/or NMES) is capable of improving the short-term effects of pulmonary rehabilitation and also promoting improved balance.
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.
Exclusion Criteria:
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IMT + NMES + Pulmonary Rehabilitation IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
Device: Multimodal training
IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
Device: IMT + Pulmonary Rehabilitation
NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
Device: NMES + Pulmonary Rehabilitation
Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
Device: Pulmonary Rehabilitation
IMT will be performed using the POWERbreathe® Medic Plus inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. The IMT wil be performed two times per week for 8 weeks. NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks. Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
IMT will be performed using the POWERbreathe® Medic Plus (POWERbreathe Medic Plus ®, SP, BR) inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. After that, load increases occurred as follows: 35% of MIP in week 3, 40% of MIP in week 4, 45% of MIP in week 5, 50% of MIP at week 6, 55% of MIP in week 7, and 60% of MIP in weeks 8. Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks. Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of pressure displacement amplitude in the anteroposterior direction (COP) (cm).
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the area of ellipse (AE) (cm2).
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the velocity of displacement of center of pressure (COPvel) (cm/s).
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of area of pressure and area of ellipse (AE) (cm2).
Time frame: Post-intervention (change after 8 weeks of training)
Static postural balance
Static postural balance (%) will assessed through Foam-Laser dynamic posturography.
Time frame: Post-intervention (change after 8 weeks of training)
Static and dynamic postural balance
Static and dynamic postural balance will assessed using the Berg Balance Scale (score points). Scores range from 0 to 56, with higher scores indicating better balance.
Time frame: Post-intervention (change after 8 weeks of training)
Static and dynamic postural balance
Static and dynamic postural balance will assessed using the Balance Evaluation Systems Test (score points). The total score of the test (108 points) will be calculated with a percentage score (0-100%) and higher scores indicate better balance performance.
Time frame: Post-intervention (change after 8 weeks of training)
Dynamic postural balance
Dynamic postural balance will assessed using the Timed Up and Go (seconds). A faster time indicate a better functional performance and a score of ≥12 seconds used as a cut-point.
Time frame: Post-intervention (change after 8 weeks of training)
Balance confidence questionnaire
Balance confidence questionnaire will measured through the Activities Specific Balance Confidence Scale (total score points). The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).
Time frame: Post-intervention (change after 8 weeks of training)
Balance confidence questionnaire
Balance confidence questionnaire will measured through Falls Efficacy Scale-International (total score points). The total score ranges from 16 to 64 points. Higher values indicate less fall-related self-efficacy (and more concern about falling).
Time frame: Post-intervention (change after 8 weeks of training)
Peripheral muscle strength
Handgrip strength and quadriceps muscle strength will be assessed by dynamometry, respectively, Kgf and Newtons.
Time frame: Post-intervention (change after 8 weeks of training)
Respiratory muscle strength and inspiratory muscle endurance
Respiratory muscle strength (cmH2O) and inspiratory muscle endurance (cmH2O) will measured through digital pressure manometry and incremental and constant test, respectively
Time frame: Post-intervention (change after 8 weeks of training)
Quadriceps femoris and diaphragm thickness
Quadriceps femoris and diaphragm thickness will measured by ultrasonography
Time frame: Post-intervention (change after 8 weeks of training)
Submaximal level of functional capacity
Submaximal level of functional capacity will measured by 6-minute walk test
Time frame: Post-intervention (change after 8 weeks of training)
Health-related quality of life at 8 week
Health-related quality of life will measured by Saint George's Respiratory Questionnaire. Overall scores range from 0 (no effect on quality of life) to a maximum score of 100 (maximum perceived distress).
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Dichlorofluorescein Diacetate - DCF-DA (picomoles / mL).
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Thiobarbituric Acid Reactive Substances -TBARS (nmol de MDA/mL).
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Advanced Oxidation Protein Products - AOPPs (µmol/L).
Time frame: Post-intervention (change after 8 weeks of training)
Oxidant profile
The oxidant profile will be assessed by Total Oxidant Status - TOS (mmol Trolox Equiv/L).
Time frame: Post-intervention (change after 8 weeks of training)
Antioxidant profile
The antioxidant profile will be assessed by Ferric Reducing Antioxidant Power - FRAP- (µmol/L)
Time frame: Post-intervention (change after 8 weeks of training)
Antioxidant profile
The antioxidant profile will be assessed by Total Antioxidant Capacity- CAT (mmol Trolox Equiv/L).
Time frame: Post-intervention (change after 8 weeks of training)
Muscle damage
Muscle damage will assessed through creatine phosphokinase (total CPK) (U/L).
Time frame: Post-intervention (change after 8 weeks of training)
Muscle damage
Muscle damage will assessed through lactate dehydrogenase (LDH) (U/L).
Time frame: Post-intervention (change after 8 weeks of training)
Muscle damage
Muscle damage will assessed through lactate parameter (mg/dL).
Time frame: Post-intervention (change after 8 weeks of training)
DNA damage
DNA damage will assessed by means of the Comet and micronucleus assay
Time frame: Post-intervention (change after 8 weeks of training)
Endothelial function
Endothelial function will assessed through nitrite/nitrate oxide (NOx) (µmol/L)
Time frame: Post-intervention (change after 8 weeks of training)
Peripheral muscle resistance of the lower limbs
Peripheral muscle resistance of the lower limbs will assessed through 30-second Sit-to-Stand tests (repetitions)
Time frame: Post-intervention (change after 8 weeks of training)
Ran from Oct 2019 to primary completion in Mar 2023, 41 months.
Of 1,095 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 41 months is above that.
Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Universidade Federal de Santa Maria