NCT02731482

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

March 30, 2016

Last Update Submit

August 15, 2019

Conditions

Keywords

BronchiectasisRehabilitationQuality of LifePhysiotherapy Specialty

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

EXPERIMENTAL

Patients with bronchiectasis in home-based pulmonary rehabilitation

Other: Training Group

Control Group

ACTIVE COMPARATOR

Patients with bronchiectasis in usual care and recommendations for performing exercises

Other: Control Group

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.

Also known as: Physical training intervention
Training 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.

Also known as: Physical activity intervention
Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Location

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.

MeSH Terms

Conditions

Bronchiectasis

Interventions

Sensitivity Training GroupsControl Groups

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Simone Dal Corso, PT, PhD

    University of Nove de Julho

    STUDY DIRECTOR

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

Locations