Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program (PCBCQ)
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
pulmonary rehabilitation
conventional program
Sponsored by
About this trial
This is an interventional other trial for Bronchiectasis focused on measuring bronchiectasis, functional capacity, lung functional
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
Sites / Locations
- Universidade Nove de Julho
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
conventional program
pulmonary rehabilitation
Arm 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.
Duration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes.
Outcomes
Primary Outcome Measures
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.
Pulmonary Function
For the cohort follow up, forced expiratory volume in the first second will be primary outcome
Exacerbations and Hospitalizations per year
For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated
Survival in months
For the cohort follow up, the survival will be evaluated in months.
Secondary Outcome Measures
Full Information
NCT ID
NCT02208830
First Posted
March 7, 2012
Last Updated
August 27, 2022
Sponsor
University of Nove de Julho
Collaborators
InCor Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT02208830
Brief Title
Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
InCor Heart Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
bronchiectasis, functional capacity, lung functional
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional program
Arm Type
Experimental
Arm 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.
Arm Title
pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Duration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes.
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Other Intervention Name(s)
exercise, rehabilitation, treatment, pulmonary
Intervention Description
Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill training and lower limb strength training.
Intervention Type
Other
Intervention Name(s)
conventional program
Other Intervention Name(s)
physiotherapy, treatment respiratory
Intervention 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.
Primary Outcome Measure Information:
Title
The change in exercise capacity in patients with bronchiectasis
Description
Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.
Time Frame
Up to 36 months
Title
Pulmonary Function
Description
For the cohort follow up, forced expiratory volume in the first second will be primary outcome
Time Frame
Up to 36 months
Title
Exacerbations and Hospitalizations per year
Description
For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated
Time Frame
Up to 36 months
Title
Survival in months
Description
For the cohort follow up, the survival will be evaluated in months.
Time Frame
Up to 36 months
Other Pre-specified Outcome Measures:
Title
Peripheral muscle function is measured by
Description
The maximal voluntary contraction in upper and lower limb was applied during the visits.
Time Frame
Up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anderson Alves de Camargo, master's
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rejane Agnelo Silva de Castro, Student
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Nove de Julho
City
São Paulo
ZIP/Postal Code
01504001
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
33886789
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.
Results Reference
derived
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Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program
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