Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program

Brief Title

Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program

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.

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.
    

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

The reduction in exercise capacity in patients with bronchiectasis

Secondary Outcome

 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).

Condition

Bronchiectasis

Intervention

pulmonary rehabilitation

Study Arms / Comparison Groups

 conventional program

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

50

Start Date

January 2012

Completion Date

January 2016

Primary Completion Date

December 2015

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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Anderson Alves de Camargo, master's, , 

Location Countries

Brazil

Location Countries

Brazil

NCT ID

NCT02208830

Organization ID

BCQPC

Responsible Party

Principal Investigator

Study Sponsor

University of Nove de Julho

Collaborators

 InCor Heart Institute

Study Sponsor

Anderson Alves de Camargo, master's, Principal Investigator, University of Nove de Julho

Verification Date

January 2016