Short-and Long-term Effects of a Home-based Rehabilitation Program in Patients With Bronchiectasis
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedAugust 16, 2019
August 1, 2019
3.2 years
March 30, 2016
August 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distance, in meters, performed in the Incremental Shuttle Walk Test
Measurement of functional capacity and exercise tolerance
up to 9 months
Secondary Outcomes (5)
Time, in seconds, performed in the Endurance Shuttle Walk Test
up to 9 monthsst
Number of steps performed in the Incremental Step Test
up to 9 months
Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)
up to 9 months
Kilogram-force (kgf) of quadriceps femoris
up to 9 months
Number of steps per day, measured by a pedometer
up to 9 months
Study Arms (2)
Training Group
EXPERIMENTALPatients with bronchiectasis in home-based pulmonary rehabilitation
Control Group
ACTIVE COMPARATORPatients with bronchiectasis in usual care and recommendations for performing exercises
Interventions
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.
* 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nove de Julholead
- University of Sao Paulocollaborator
Study Sites (1)
Universidade Nove de Julho
São Paulo, 01504-001, Brazil
Related Publications (1)
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.
PMID: 28869119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simone Dal Corso, PT, PhD
University of Nove de Julho
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PT, PhD
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 7, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
August 16, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share