Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program (PCBCQ)

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.

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Other: conventional program; Other: pulmonary rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504001
    • Universidade Nove de Julho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: conventional program; 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.	Other: conventional program; 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.; Other Names: physiotherapy; treatment respiratory
EXPERIMENTAL: pulmonary rehabilitation; Duration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes.	Other: pulmonary rehabilitation; Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill training and lower limb strength training.; Other Names: rehabilitation; exercise; treatment; pulmonary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in exercise capacity in patients with bronchiectasis	Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.	Up to 36 months
Pulmonary Function	For the cohort follow up, forced expiratory volume in the first second will be primary outcome	Up to 36 months
Exacerbations and Hospitalizations per year	For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated	Up to 36 months
Survival in months	For the cohort follow up, the survival will be evaluated in months.	Up to 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle function is measured by	The maximal voluntary contraction in upper and lower limb was applied during the visits.	Up to 36 months

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: InCor Heart Institute
• Investigators: Principal Investigator: Anderson Alves de Camargo, master's, University of Nove de Julho; Principal Investigator: Rejane Agnelo Silva de Castro, Student, University of Nove de Julho

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (ESTIMATE): August 5, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 27, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: functional capacity; bronchiectasis; lung functional
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: BCQPC