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

May 12, 2022 updated by: Hospital Universitario Virgen Macarena

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41009
        • Virginia Almadana Pacheco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)
Participants were given two hospital sessions: in the first session the physiotherapist explained the exercises to be performed at home and there was a reminder session at 4 weeks. Reminder call was carried out weekly for 8 weeks. The patients were advised to do the exercises at least 3 times a week. The number of times they performed physical activity and its duration were recorded in a questionnaire
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

Other Names:
  • Intervention group
NO_INTERVENTION: Control group
Participants received general written advice and recommendations for physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and week 8
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.
Baseline and week 8
Dyspnoea
Time Frame: Baseline and week 8
Change in dyspnoea by modified Medical Research Council (MRC)
Baseline and week 8
Exacerbations
Time Frame: Baseline, week 4 and week8
Numbers of Hospital admissions in previous month
Baseline, week 4 and week8
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).
Baseline and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen Macarena

Investigators

  • Study Director: Virginia Almadana, PhD, Virgen Macarena University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 8, 2018

Primary Completion (ACTUAL)

March 14, 2019

Study Completion (ACTUAL)

March 14, 2020

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (ACTUAL)

May 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHNR15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It will be available in the repository of the Virgen Macarena University Hospital

IPD Sharing Time Frame

May 07, 2018 to march 14, 2020

IPD Sharing Access Criteria

Upon request from the database, the data will be provided with the prior consent of the hospital ethics committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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