NCT03273959.
Study name | Program of exercises during the hospitalization of children and adolescents with cystic fibrosis |
Methods |
Design: parallel, single‐centre RCT; single blinded (outcome assessor) Location: Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil Duration: 14 days |
Participants |
Estimated enrolment: 50 participants hospitalised for treatment of a pulmonary exacerbation Inclusion criteria: males and females with CF; age 6–18 years and followed by the Pediatric Pulmonology Team at Hospital de Clínicas de Porto Alegre; hospital admission defined as "a stay of 24 hours or more in any Hospital de Clinicas de Porto Alegre unit"; exacerbation of lung disease defined as the presence of ≥ 1 of the following: change in sputum volume and colour, new or enlarged haemoptysis, increased cough, increased dyspnoea, malaise, fatigue, lethargy, fever, anorexia or weight loss, headache or pain in the sinuses, alteration of the pulmonary auscultation, non‐FEV1 decrease of > 10%, radiological [sic], eradication of new bacteria Exclusion criteria: cardiac, orthopaedic or trauma complications that make it impossible to perform the proposed exercises; haemodynamic instability, massive haemoptysis, pneumothorax; continuous use of non‐invasive ventilation; pregnancy |
Interventions |
Intervention group: routine physical therapy plus exercise programme in the form of a booklet and guided by a health professional. Programme includes exercises such as punching, climbing and descending stairs, sit and stand, push‐up on the wall, cycling and others, performed 5 times per week. Participants record their training in a diary. The programme is not supervised. Control group: routine physical therapy during hospitalisation |
Outcomes |
Primary outcome
Secondary outcomes
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Starting date | 28 August 2017 |
Contact information | Hospital de Clínicas de Porto Alegre, Brazil, 90035‐903 Bruna Ziegler: telephone: +55 51991221192; E‐mail: brunaziegler@yahoo.com.br Taiane Feiten: telephone: +55 51991539788; E‐mail: taifeiten@gmail.com |
Notes | Recruitment status: unknown (latest update 6 September 2017); estimated study completion date: 28 March 2019 Contacted Ms Ziegler for more information about the status of the study (30 June 2021). |