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Completed

NCT Number: NCT02731482

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training group

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.

Other names: Physical training intervention

Control Group

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.

Other names: Physical activity intervention

Primary outcomes

  1. Distance, in meters, performed in the Incremental Shuttle Walk Test

    Time frame: up to 9 months

    Measurement of functional capacity and exercise tolerance

Secondary outcomes

  1. Time, in seconds, performed in the Endurance Shuttle Walk Test

    Time frame: up to 9 monthsst

    Measurement of functional capacity and exercise tolerance

  2. Number of steps performed in the Incremental Step Test

    Time frame: up to 9 months

    Measurement of functional capacity and exercise tolerance

  3. Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)

    Time frame: up to 9 months

    Quality of Life Questionnaire

  4. Kilogram-force (kgf) of quadriceps femoris

    Time frame: up to 9 months

    Peripheral Muscle Strength

  5. Number of steps per day, measured by a pedometer

    Time frame: up to 9 months

    Physical activity in daily life

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2016
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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