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. 2022 Aug 9;2022(8):CD002768. doi: 10.1002/14651858.CD002768.pub5

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
  1. Change in 6‐min walk test distance from baseline to hospital discharge (14 days)


Secondary outcomes
  1. Change in spirometry (outcome variables not defined) from baseline to hospital discharge (14 days)

  2. Change in physical fitness and health score (score and instrument not defined) from baseline to hospital discharge (14 days)

  3. Change in BMI from baseline to hospital discharge (14 days)

  4. Change in clinical Shwachman‐Kulczycki score from baseline to hospital discharge (14 days)

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).