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

Bronchiectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731482
• Other study ID #: Bronchiectasis Rehabilitation
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Nove de Julho	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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