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

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Training Group
Control Group
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, Rehabilitation, Quality of Life, Physiotherapy Specialty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Training Group

Control Group

Arm Description

Patients with bronchiectasis in home-based pulmonary rehabilitation

Patients with bronchiectasis in usual care and recommendations for performing exercises

Outcomes

Primary Outcome Measures

Distance, in meters, performed in the Incremental Shuttle Walk Test
Measurement of functional capacity and exercise tolerance

Secondary Outcome Measures

Time, in seconds, performed in the Endurance Shuttle Walk Test
Measurement of functional capacity and exercise tolerance
Number of steps performed in the Incremental Step Test
Measurement of functional capacity and exercise tolerance
Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)
Quality of Life Questionnaire
Kilogram-force (kgf) of quadriceps femoris
Peripheral Muscle Strength
Number of steps per day, measured by a pedometer
Physical activity in daily life

Full Information

First Posted
March 30, 2016
Last Updated
August 15, 2019
Sponsor
University of Nove de Julho
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02731482
Brief Title
Short-and Long-term Effects of a Home-based Rehabilitation Program in Patients With Bronchiectasis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Rehabilitation, Quality of Life, Physiotherapy Specialty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Description
Patients with bronchiectasis in home-based pulmonary rehabilitation
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients with bronchiectasis in usual care and recommendations for performing exercises
Intervention Type
Other
Intervention Name(s)
Training Group
Other Intervention Name(s)
Physical training intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Physical activity intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distance, in meters, performed in the Incremental Shuttle Walk Test
Description
Measurement of functional capacity and exercise tolerance
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Time, in seconds, performed in the Endurance Shuttle Walk Test
Description
Measurement of functional capacity and exercise tolerance
Time Frame
up to 9 monthsst
Title
Number of steps performed in the Incremental Step Test
Description
Measurement of functional capacity and exercise tolerance
Time Frame
up to 9 months
Title
Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)
Description
Quality of Life Questionnaire
Time Frame
up to 9 months
Title
Kilogram-force (kgf) of quadriceps femoris
Description
Peripheral Muscle Strength
Time Frame
up to 9 months
Title
Number of steps per day, measured by a pedometer
Description
Physical activity in daily life
Time Frame
up to 9 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Dal Corso, PT, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28869119
Citation
Jose A, Holland AE, Oliveira CS, Selman JPR, Castro RAS, Athanazio RA, Rached SZ, Cukier A, Stelmach R, Corso SD. Does home-based pulmonary rehabilitation improve functional capacity, peripheral muscle strength and quality of life in patients with bronchiectasis compared to standard care? Braz J Phys Ther. 2017 Nov-Dec;21(6):473-480. doi: 10.1016/j.bjpt.2017.06.021. Epub 2017 Aug 19.
Results Reference
derived

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

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