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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary rehabilitation home-based program intervention group (PRHP)(IG) | Experimental | 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 |
|
| Control group | No Intervention | Participants received general written advice and recommendations for physical activity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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) | A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program. | Baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Impact of quality of life before and after PRHP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Almadana, PhD | Hospital Universitario Virgen Macarena | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Almadana Pacheco | Seville | 41009 | Spain |
It will be available in the repository of the Virgen Macarena University Hospital
May 07, 2018 to march 14, 2020
Upon request from the database, the data will be provided with the prior consent of the hospital ethics committee.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2018 |
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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
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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 | Change in dyspnoea by modified Medical Research Council (MRC) | Baseline and week 8 |
| Exacerbations | 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 | Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (number of steps). | Baseline and week 8 |
| May 10, 2022 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2018 | May 10, 2022 | ICF_003.pdf |