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

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Other: Training Group; Other: Control Group

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Universidade Nove de Julho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Physical activity intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance, in meters, performed in the Incremental Shuttle Walk Test	Measurement of functional capacity and exercise tolerance	up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time, in seconds, performed in the Endurance Shuttle Walk Test	Measurement of functional capacity and exercise tolerance	up to 9 monthsst
Number of steps performed in the Incremental Step Test	Measurement of functional capacity and exercise tolerance	up to 9 months
Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)	Quality of Life Questionnaire	up to 9 months
Kilogram-force (kgf) of quadriceps femoris	Peripheral Muscle Strength	up to 9 months
Number of steps per day, measured by a pedometer	Physical activity in daily life	up to 9 months

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: University of Sao Paulo
• Investigators: Study Director: Simone Dal Corso, PT, PhD, University of Nove de Julho

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 2, 2016
• First Posted (Estimate): April 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Quality of Life; Bronchiectasis; Physiotherapy Specialty
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: Bronchiectasis Rehabilitation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No