Ganderton 2013.
Methods |
Study design: RCT Study grouping: Parallel group |
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Participants |
Baseline characteristics Exercise
Control
Included criteria: participants were included in the study if they had a confirmed diagnosis of idiopathic PAH, familial PAH or PAH associated with connective tissue disorders, based on elevated pulmonary artery pressures (> 25 mmHg at rest or > 30 mmHg during exercise) measured by right heart catheterisation; were medically stable and had been on PAH‐specific pharmaceutical therapy for 3 months prior to enrolment into the study; were in WHO functional class II or III; and were willing to complete the 12‐week supervised and 12‐week home exercise training programmes. Excluded criteria: participants were excluded if they had:
Pretreatment: nil |
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Interventions |
Intervention characteristics Exercise
Control
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Outcomes | 6MWD VO2peak Wpeak Anaerobic threshold HRQoL (SF‐36): Physical functioning HRQoL (Sf‐36): Role physical HRQoL (SF36): Bodily pain HRQoL (SF‐36): General health HRQoL (SF‐36): Vitality HRQoL (SF‐36): Social function HRQoL (SF‐36): Role emotional HRQoL (SF‐36): Mental health HRQol (CAMPHOR): Symptoms HRQol (CAMPHOR): Activities HRQol (CAMPHOR): QoL Morbidity Disease progression Symptoms precluding training Discontinued training NYHA class HRQoL: Physical summary score (SF‐36) HRQoL: Mental summary score (SF‐36) Assessed at baseline, 12 weeks (post intervention) and 24 weeks (follow‐up) |
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Identification |
Sponsorship source: Advanced Lung Disease Unit at Royal Perth Hospital and the Lung Institute of Western Australia Country: Australia Setting: Outpatient, hospital Comments: Author's name: Louise Ganderton Institution: Curtin University Email: louise.ganderton@health.wa.gov.au Address: School of Physiotherapy, Faculty of Health Sciences, The University of Sydney |
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Notes | Protocol paper published: Ganderton 2011 Thesis available: http://espace.library.curtin.edu.au:80/R?func=dbin‐jump‐full&local_base=gen01‐era02&object_id=198083 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | From thesis: "Permuted block randomisation with block sizes of four was used to generate a randomisation chart. Fourteen blocks were created in total using a web‐based research randomiser." |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants to intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | From thesis: "The primary investigator (LG) carried out all assessments at baseline, 12 weeks and 24 weeks and was blinded to the participants group allocation...The physiotherapists responsible for conducting the exercise training sessions were not involved in any of the formal assessments" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data available on all recruited participants for ITT. However planned to enrol 34 and only recruited 10 |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk |