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

Pulmonary Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369624
• Other study ID #: SCHNR15
• Status: Completed
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: March 14, 2020

Study information

• Verified date: April 2022
• Source: Hospital Universitario Virgen Macarena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 14, 2020
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis
• Non-cystic Fibrosis Bronchiectasis
• Pulmonary Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Spain	Virginia Almadana Pacheco	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)	A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program.	Baseline and week 8
Secondary	Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP	Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (METS).	Baseline and week 8
Secondary	Impact of quality of life before and after PRHP	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.	Baseline and week 8
Secondary	Dyspnoea	Change in dyspnoea by modified Medical Research Council (MRC)	Baseline and week 8
Secondary	Exacerbations	Numbers of Hospital admissions in previous month	Baseline, week 4 and week8
Secondary	Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP	Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (number of steps).	Baseline and week 8