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NCT Number: NCT05369624

Exercise Capacity in Non-cystic Fibrosis Bronchiectasis After a Pulmonary Rehabilitation Home-based Program

A number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-CF Bronchiectasis), although little research exists on using the cardiopulmonary exercise test (CPET) to evaluate exercise capacity and its most relevant changes after a pulmonary rehabilitation home-based program (PRHP). In addition, few studies have addressed tolerance to exercise and physical activity in severe cases of the disease.

Aims:

To evaluate the exercise capacity of non-CF BQ patients using CPET and physical activity after a pulmonary rehabilitation home-based program.

Methodology:

Our study describes a non-pharmacological clinical trial in non-CF BQ patients at the Virgen Macarena University Hospital (Seville, Spain). The patients were randomized into two groups: the control group (who were provided with training instructions) and the intervention group (who took part in a specific pulmonary rehabilitation home-based program).

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Key information

Conditions

Non-cystic Fibrosis Bronchiectasis Pulmonary Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Almadana Pacheco

Seville, 41009, Spain

About this study

A signed informed consent form was provided prior to inclusion in the study. The data evaluated was obtained under strict confidentiality rules. All patients passed an initial assessment of the degree of physical activity by means of accelerometers, as well as pulmonary function tests and exercise tolerance (CPET) and 6MWT, stratification severity according to the E-FACED scales, quality of life using the saint george respiratory questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Certain diagnosis of non-CF bronchiectasis (chest HRCT)
  • Over 18 years old, clinically stable in the previous 6 weeks (no need for antibiotic therapy due to exacerbations) and a dyspnea score over 1 according to the modified Medical Research Council (mMRC) dyspnea scale

Exclusion criteria

  • Less of 18 years
  • Other airway disease ( Asthma or COPD)
  • Physical inability to perform a physical training program (neuromuscular pathology or residual injuries).
  • Smokers or former smokers of less than 6 months or with a history of consumption of 15 packs/year.
  • Cystic fibrosis.
  • Active infections (bronchopulmonary aspergillosis, pulmonary tuberculosis).
  • Active tuberculosis.
  • Medical illnesses that put the individual at risk of a decompensation due to the performance of any physical activity or cardiopulmonary stress test (unstable ischemic heart disease, acute myocardial infarction less than 1 month).
  • Pregnancy
  • Mental disorder that prevents the adequate interpretation of the indications or performance of the tests.
  • Attended pulmonary rehabilitation within 1 year.

Treatment and study plan

Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)

Other

The strength training program included upper and lower limb exercises, initially with no weights but progressively adding weights once a week depending on symptoms, in 2 sets with 6-8 repetitions, for at least 5 days a week. The exercises recommended were the 'hanger' (which exercises the latissimus dorsi muscle), 'butterfly' (pectoralis major muscle), 'neck press' (triceps brachii and deltoids), leg flexion (biceps femoris and gastrocnemius) and leg extension (quadriceps femoris).

As resistance training, patients could choose between walking or cycling 3 to 5 days per week, for at least 20 minutes, increasing the duration of the exercise weekly, depending on their symptoms

Other names: Intervention group

Primary outcomes

  1. Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)

    Time frame: Baseline and week 8

    A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program.

Secondary outcomes

  1. Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP

    Time frame: Baseline and week 8

    Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (METS).

  2. Impact of quality of life before and after PRHP

    Time frame: Baseline and week 8

    Change in St. George's Respiratory Questionnaire (SGRQ) after PRHP: Have 50 items with 3 components Symptoms, Activities, Impact ant total score. Scores range from 0 to 100, with higher scores indicating more limitations.

  3. Dyspnoea

    Time frame: Baseline and week 8

    Change in dyspnoea by modified Medical Research Council (MRC)

  4. Exacerbations

    Time frame: Baseline, week 4 and week8

    Numbers of Hospital admissions in previous month

  5. Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP

    Time frame: Baseline and week 8

    Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (number of steps).

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen Macarena

Other

Registry information

Official study title

Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 11, 2022
Registry last updated
May 18, 2022

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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