Clinical trial NCT02208830: Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program
Official title: Effects of Pulmonary Rehabilitation Associated With Respiratory Therapy vs Physiotherapy in Physical Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: bronchiectasis
functional capacity
lung functional
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2014-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The hypothesis of this study is that the group of patients who will carry out the rehabilitation program associated with respiratory therapy will have higher benefits in physical function, peripheral muscle strength and quality of life compared to the group that will only perform chest physiotherapy. Additionally, there will be a negative correlation between inflammatory mediators and measures of physical ability as well as the magnitude of improvement is lower after treatment in patients with higher baseline levels of inflammation. Furthermore, these patients will be reevaluated in 1 and 3 years, as a cohort, studying if exercise capacity may be a predictor of clinical and functional outcomes.

Detailed description: All patients will have their dyspnea rated according to the Medical Research Council (MRC) scale. The Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment test (CAT) will also be applied.

Spirometry will be performed according to recommendations of the American Thoracic Society/European Respiratory Society. The forced vital capacity and forced expiratory volume values in the first second will be compared with those predicted for the Brazilian population.

The maximal incremental cycle ergometer test will be carried out on an electromagnetically braked cycle ergometer with gas exchange and ventilatory variables analyzed breath-by-breath. After 2 min at rest and then 2 min pedaling in freewheel, the power (W) will continuously increase in a linear "ramp" pattern (1 to 20 W/min).

The incremental treadmill test will be performed to determine aerobic training load. The modified Balke protocol, according to the basal level of physical fitness (a total time increment between eight and 12 minutes).

The incremental shuttle walking test will be conducted according to the description of Singh et al.

The daily physical activity (DPA) will be assessed with an accelerometer for three days.

Blood sample for inflammatory markers measurements will be collected to analyze of IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha, using Duo Set ELISA kits from R \& D Systems according to manufacturer's instructions.

Muscle strength with one repetition maximum (1RM) will be performed at middle deltoid (MD), biceps brachial (BB) and quadriceps femoris (QF). The following movements will also be evaluated: shoulder abduction, elbow flexion and knee extension.

Patients are going to be randomized to pulmonary rehabilitation or conventional physiotherapy program as follow:

Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill and lower limb strength training.

Conventional program: 8 week, twice weekly conventional program with: L'Expiration Lente Totale Glotte Ouverte en decubitus Latéral (Eltgol), autogenous drainage (AD) and shaker with duration of 30 minutes each.

Patients will be reassessed in 1 and 3 years, measuring maximal incremental cycle ergometer test, incremental treadmill test, incremental shuttle walking test, accelerometer and muscle strength. All tests will follow the same patterns as the first assesment. Adicionally, exacerbations, hospitalization and survival in each year will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical and / or CT of bronchiectasis without cystic fibrosis
* Clinically stable (no change in symptoms of dyspnea, quantity and color of the secretion)
* Greater than 18 and / or oxygen dependent at home
* Medical Research Council MRC ≥ 1.

Exclusion Criteria:

* Smokers or smoking history\> 10 pack / years,
* Cystic fibrosis (CF)
* Chronic obstructive pulmonary disease (COPD)
* Asthma
* Pulmonary fibrosis (PF)
* Musculoskeletal limitations

Primary outcomes:
measure: The change in exercise capacity in patients with bronchiectasis
timeFrame: Up to 36 months
measure: Pulmonary Function
timeFrame: Up to 36 months
measure: Exacerbations and Hospitalizations per year
timeFrame: Up to 36 months
measure: Survival in months
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
measure: Peripheral muscle function is measured by
timeFrame: Up to 36 months
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Anderson Alves de Camargo, master's
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nove de Julho
name: Rejane Agnelo Silva de Castro, Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Camargo AA, de Castro RAS, Vieira RP, Oliveira-Junior MC, Araujo AA, De Angelis K, Rached SZ, Athanazio RA, Stelmach R, Corso SD. Systemic Inflammation and Oxidative Stress in Adults with Bronchiectasis: Association with Clinical and Functional Features. Clinics (Sao Paulo). 2021 Apr 16;76:e2474. doi: 10.6061/clinics/2021/e2474. eCollection 2021.