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. 2017 Jan 18;2017(1):CD011285. doi: 10.1002/14651858.CD011285.pub2

Ganderton 2013.

Methods Study design: RCT
Study grouping: Parallel group
Participants Baseline characteristics
Exercise
  • Number enrolled: 5

  • Gender (male/female): 0/5

  • Age (years): 51 (40–53)

  • Body Mass Index: 26 (23–41)

  • Haemodynamics: mPAP (mmHG, RHC): 23 (19‐29)

  • Haemodynamics: PVR (Dynes, RHC):

  • FVC (% predicted): 98 (92–102)

  • NYHA WHO Functional Class (I/II/III/IV): 0/3/2/0

  • Medications (single/double/triple): 3/2

  • Median sessions 31 of 26


Control
  • Number enrolled: 5

  • Gender (male/female): 1/4

  • Age (years): 53 (42–57)

  • Body Mass Index: 28 (26–31)

  • Haemodynamics: mPAP (mmHG, RHC): 49 (20‐65)

  • Haemodynamics: PVR (Dynes, RHC):

  • FVC (% predicted): 78 (72–110)

  • NYHA Functional Class (I/II/III/IV): 0/3/2/0

  • Medications (single/double/triple): 3/2


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:
  • resting hypoxaemia requiring supplemental oxygen therapy;

  • significant musculoskeletal disease, claudication pain, neurological or cognitive impairment, psychiatric/psychological or mood disorders that may have affected their ability to undertake exercise testing or training;

  • a history of moderate or severe chronic lung disease;

  • cardiac disease associated with cardiac failure, poorly controlled angina, unstable cardiac rhythm;

  • participated in a supervised exercise training programme within the last 12 months


Pretreatment: nil
Interventions Intervention characteristics
Exercise
  • Setting: outpatient

  • Components: exercise only

  • Training dose (frequency number per week): 3 times per week, 12 weeks

  • Training dose (duration ‐ min): 60 min class

  • Training dose (intensity): 12 weeks. "Intensity for the lower limb endurance exercises will be prescribed with the aim of achieving 60‐70% HR max (based on age predicted maximum,220‐age [37]), while maintaining SpO2 ≥ 92% and symptom intensity (Borg CR10 dyspnoea < 4 and RPE < 4). Exercise intensity will be progressed, based on the individual’s response to training to maintain HR within the target HR range."

  • Training dose (mode): lower limb endurance training (walking and cycling). Lower limb functional strength training (step ups and sit to stands) and endurance training of the upper limbs

  • Education (total hours): 0


Control
  • Training dose (frequency number per week): nil

  • Training dose (duration ‐ min): nil

  • Training dose (intensity): nil

  • Training dose (mode): nil

  • Education (total hours): 0

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)
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
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
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