Skip to main content
OpenTrials
Completed

NCT Number: NCT02208830

Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Nove de Julho

São Paulo, 01504001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

Other

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

Other names: exercise, rehabilitation, treatment, pulmonary

Conventional Program

Other

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

Primary outcomes

  1. The change in exercise capacity in patients with bronchiectasis

    Time frame: Up to 36 months

    Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.

  2. Pulmonary Function

    Time frame: Up to 36 months

    For the cohort follow up, forced expiratory volume in the first second will be primary outcome

  3. Exacerbations and Hospitalizations per year

    Time frame: Up to 36 months

    For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated

  4. Survival in months

    Time frame: Up to 36 months

    For the cohort follow up, the survival will be evaluated in months.

Other outcomes

  1. Peripheral muscle function is measured by

    Time frame: Up to 36 months

    The maximal voluntary contraction in upper and lower limb was applied during the visits.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • InCor Heart Institute

Registry information

Official study 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.

Acronym: PCBCQ

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2014
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.