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

NCT ID: NCT02731482

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-08-31

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.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training Group

Patients with bronchiectasis in home-based pulmonary rehabilitation

Group Type: EXPERIMENTAL

Training Group

Intervention Type: OTHER

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

Patients with bronchiectasis in usual care and recommendations for performing exercises

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Physical training intervention; Physical activity intervention

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Anderson José

PT, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Dal Corso, PT, PhD

Role: STUDY_DIRECTOR

University of Nove de Julho

Locations

Universidade Nove de Julho

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28869119 (View on PubMed)

Other Identifiers

Bronchiectasis Rehabilitation

Identifier Type: -

Identifier Source: org_study_id