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Short-and Long-term Effects of a Home-based Rehabilitation Program in Patients With Bronchiectasis

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ClinicalTrials.gov Identifier: NCT02731482
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Anderson José, University of Nove de Julho

Study Description
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Brief Summary:
This study will investigate the short-and long-term effects of the home-based pulmonary rehabilitation on peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. The participants will be randomized into two groups: control group (usual care and recommendations for practice exercise) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. At baseline, immediately after finishing and after six months the patients will undergo assessments.

Condition or disease Intervention/treatment Phase
Bronchiectasis Other: Training Group Other: Control Group Not Applicable

Detailed Description:
Home-based pulmonary rehabilitation (HBPR) has been used in patients with chronic obstructive pulmonary disease, asthma and pulmonary fibrosis. Results from HBPR have been similar to those observe in the outpatient pulmonary rehabilitation such improvement in exercise capacity, symptoms and quality of life. However, HBPR has not yet been investigated in patients with bronchiectasis, a progressive and debilitating disease with a high socioeconomic impact. Objective: To investigate the short-and long-term effects of the home rehabilitation program in peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. Methods: Patients diagnosed with bronchiectasis will be recruited from the Obstructive Diseases Outpatient Clinic of the Hospital das Clínicas - Medicine School, University of São Paulo. Participants will be randomized into two groups: control group (usual care and recommendations for performing exercises and respiratory physiotherapy) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. All patients will receive a phone call once a week and patients allocated to the training group, additionally, will get a home visit every 15 days. At baseline, immediately after finishing and after six months of the HBPR patients will undergo to assessments. Expected results: HBPR will have positive effects on exercise tolerance and quality of life. Also, this study will contribute to future guidelines on the recommendation of HBPR for patients with bronchiectasis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Short-and Long-term Effects of a Home-based Rehabilitation Program on Functional Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: Randomized Controlled Trial
Study Start Date : June 2016
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Training Group
Patients with bronchiectasis in home-based pulmonary rehabilitation
 Other: Training Group

Three sessions per week, each lasting 50 minutes, during eight weeks.

  • Aerobic training in stepping training.
  • Resistance training: Three sets of eight repetitions each, in both simultaneous members, using an elastic band. The trained muscles are quadriceps, hamstrings, deltoid and biceps.
  • Once a week, patients will receive a phone call and every two weeks, patients will get a visit of the researcher at his home.
Other Name: Physical training intervention
Active Comparator: Control Group
Patients with bronchiectasis in usual care and recommendations for performing exercises
 Other: Control Group
  • The participants will receive verbal and written information about the importance of physical activity and walk in moderate intensity, at least, three times a week for 30 minutes.
  • Participants will not receive any supervised physical training.
  • Once a week, patients will receive a phone call to provide support and general advice.
Other Name: Physical activity intervention


Outcome Measures
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Primary Outcome Measures :
  1. Distance, in meters, performed in the Incremental Shuttle Walk Test [ Time Frame: up to 9 months ]
    Measurement of functional capacity and exercise tolerance


Secondary Outcome Measures :
  1. Time, in seconds, performed in the Endurance Shuttle Walk Test [ Time Frame: up to 9 monthsst ]
    Measurement of functional capacity and exercise tolerance

  2. Number of steps performed in the Incremental Step Test [ Time Frame: up to 9 months ]
    Measurement of functional capacity and exercise tolerance

  3. Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B) [ Time Frame: up to 9 months ]
    Quality of Life Questionnaire

  4. Kilogram-force (kgf) of quadriceps femoris [ Time Frame: up to 9 months ]
    Peripheral Muscle Strength

  5. Number of steps per day, measured by a pedometer [ Time Frame: up to 9 months ]
    Physical activity in daily life


Eligibility Criteria
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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:

Clinical diagnosis and/or tomographic bronchiectasis Clinically stable (no change in symptoms of dyspnea, in the amount and color of the secretion) Have completed the outpatient pulmonary rehabilitation for more than a year Not engaged in a regular physical activity.

Exclusion Criteria:

Smokers With other lung related diseases (asthma, COPD and cystic fibrosis) Severe cardiovascular diseases Musculoskeletal limitation Unable to perform the tests and the training protocol due desaturation (pulse oxygen saturation ≤ 80%) over the recommended exercise intensity.

Contacts and Locations
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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): NCT02731482


Locations
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Brazil
Universidade Nove de Julho
São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
University of Sao Paulo
Investigators
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Study Director: Simone Dal Corso, PT, PhD University of Nove de Julho
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anderson José, PT, PhD, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02731482    
Other Study ID Numbers: Bronchiectasis Rehabilitation
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anderson José, University of Nove de Julho:
Bronchiectasis
Rehabilitation
Quality of Life
Physiotherapy Specialty
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases