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Trial record 16 of 225 for:    Bronchiectasis

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

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ClinicalTrials.gov Identifier: NCT02208830
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
InCor Heart Institute
Information provided by (Responsible Party):
Anderson Alves de Camargo, University of Nove de Julho

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Other: pulmonary rehabilitation Other: conventional program Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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:
  • exercise
  • rehabilitation
  • treatment
  • pulmonary




Primary Outcome Measures :
  1. The reduction 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.


Secondary Outcome Measures :
  1. 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). [ Time Frame: Up to 36 months ]

Other Outcome Measures:
  1. Peripheral muscle function is measured by maximal voluntary contraction in upper and lower limb [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208830


Locations
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Brazil
Universidade Nove de Julho
São Paulo, Brazil, 01504001
Sponsors and Collaborators
University of Nove de Julho
InCor Heart Institute
Investigators
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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

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Responsible Party: Anderson Alves de Camargo, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02208830     History of Changes
Other Study ID Numbers: BCQPC
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Keywords provided by Anderson Alves de Camargo, University of Nove de Julho:
bronchiectasis
functional capacity
lung functional

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases