Brief Title
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.
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.
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
The reduction in exercise capacity in patients with bronchiectasis
Secondary Outcome
The quality of life of patients with bronchiectasis will be measured by the Saint Gerge's Respiratory Questionnaire (SGRQ). The questionnaire is analyzed by three domains (symptoms, activity and impact).
Condition
Bronchiectasis
Intervention
pulmonary rehabilitation
Study Arms / Comparison Groups
conventional program
Description: The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
50
Start Date
January 2012
Completion Date
January 2016
Primary Completion Date
December 2015
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Anderson Alves de Camargo, master's, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02208830
Organization ID
BCQPC
Responsible Party
Principal Investigator
Study Sponsor
University of Nove de Julho
Collaborators
InCor Heart Institute
Study Sponsor
Anderson Alves de Camargo, master's, Principal Investigator, University of Nove de Julho
Verification Date
January 2016