Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program

NCT02208830 | Completed DMC

• 1 other identifier: BCQPC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

bronchiectasis; functional capacity; lung functional

Outcome Measures

Primary Outcomes (4)

• 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

• Pulmonary Function

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

  Up to 36 months

• Exacerbations and Hospitalizations per year

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

  Up to 36 months

• Survival in months

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

  Up to 36 months

Other Outcomes (1)

• Peripheral muscle function is measured by

  Up to 36 months

Study Arms (2)

conventional program

EXPERIMENTAL

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

pulmonary rehabilitation

EXPERIMENTAL

Duration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes.

Other: pulmonary rehabilitation

Interventions

pulmonary rehabilitation OTHER

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

Also known as: exercise, rehabilitation, treatment, pulmonary

pulmonary rehabilitation

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.

Also known as: physiotherapy, treatment respiratory

conventional program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Smokers or smoking history\> 10 pack / years,
• Cystic fibrosis (CF)
• Chronic obstructive pulmonary disease (COPD)
• Asthma
• Pulmonary fibrosis (PF)
• Musculoskeletal limitations

Sponsors & Collaborators

• University of Nove de Julho: lead
• InCor Heart Institute: collaborator

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504001, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33886789 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Exercise; Rehabilitation; Therapeutics; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anderson Alves de Camargo, master's

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

• Rejane Agnelo Silva de Castro, Student

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: August 5, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

BR (1)