Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program

Bronchiectasis Clinical Trial

— PCBCQ  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208830
• Other study ID #: BCQPC
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: July 2018

Study information

• Verified date: August 2022
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Nove de Julho	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peripheral muscle function is measured by	The maximal voluntary contraction in upper and lower limb was applied during the visits.	Up to 36 months
Primary	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
Primary	Pulmonary Function	For the cohort follow up, forced expiratory volume in the first second will be primary outcome	Up to 36 months
Primary	Exacerbations and Hospitalizations per year	For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated	Up to 36 months
Primary	Survival in months	For the cohort follow up, the survival will be evaluated in months.	Up to 36 months