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

Primary Purpose

Non-cystic Fibrosis Bronchiectasis, Pulmonary Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)
Sponsored by
Hospital Universitario Virgen Macarena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Almadana Pacheco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Control group

Arm Description

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

Participants received general written advice and recommendations for physical activity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Dyspnoea
Change in dyspnoea by modified Medical Research Council (MRC)
Exacerbations
Numbers of Hospital admissions in previous month
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).

Full Information

First Posted
April 27, 2022
Last Updated
May 12, 2022
Sponsor
Hospital Universitario Virgen Macarena
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1. Study Identification

Unique Protocol Identification Number
NCT05369624
Brief Title
Exercise Capacity in Non-cystic Fibrosis Bronchiectasis After a Pulmonary Rehabilitation Home-based Program
Official Title
Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
March 14, 2019 (Actual)
Study Completion Date
March 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario Virgen Macarena

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-cystic Fibrosis Bronchiectasis, Pulmonary Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial with parallel groups (Parallel treatment design): Clinical trial in which one group of patients is assigned to receive the home pulmonary rehabilitation program (PHRP), while another group (control) does not receive PHRP
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants received general written advice and recommendations for physical activity
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)
Other Intervention Name(s)
Intervention group
Intervention Description
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
Primary Outcome Measure Information:
Title
Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)
Description
A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program.
Time Frame
Baseline and week 8
Secondary Outcome Measure Information:
Title
Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP
Description
Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (METS).
Time Frame
Baseline and week 8
Title
Impact of quality of life before and after PRHP
Description
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.
Time Frame
Baseline and week 8
Title
Dyspnoea
Description
Change in dyspnoea by modified Medical Research Council (MRC)
Time Frame
Baseline and week 8
Title
Exacerbations
Description
Numbers of Hospital admissions in previous month
Time Frame
Baseline, week 4 and week8
Title
Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP
Description
Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (number of steps).
Time Frame
Baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Almadana, PhD
Organizational Affiliation
Virgen Macarena University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Virginia Almadana Pacheco
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.hospitalmacarena.es/

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

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