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

Ley 2013.

Methods Study design: RCT
Study grouping: Parallel group
Participants Baseline characteristics
Exercise

  • Number enrolled: 10

  • Gender (male/female): 2/8

  • Age (years): 47 (8)

  • Type of PH: Group 1 PH n = 9, CTEPH n = 1

  • Haemodynamics: mPAP (mmHG, RHC):

  • Haemodynamics: PVR (Wood Units, RHC):

  • Height (cm): 168 (12)

  • Weight (kg): 69 (11)

  • Medications (mono/dual/triple): 2/6/2

  • NYHA, WHO Functional Class (I/II/III/IV): 0/3/7/0


Control

  • Number enrolled: 10

  • Gender (male/female): 4/6

  • Age (years): 54 (14)

  • Type of PH: Group 1 PH n = 7, CTEPH n = 3

  • Haemodynamics: mPAP (mmHG, RHC):

  • Haemodynamics: PVR (Wood Units, RHC):

  • Height (cm): 165 (5)

  • Weight (kg): 76 (17)

  • Medications (mono/dual/triple): 3/6/1

  • NYHA, WHO Functional Class (I/II/III/IV): 0/1/9/0


Included criteria: adults (≥ 18 years) with confirmed PAH and CTEPH who underwent complete clinical work‐up including RHC. All participants were stable under optimised medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics and supplemental oxygen) for at least 3 months before entering the study. Additional inclusion criteria were WHO functional class II to III
Excluded criteria: no recent syncope, and no skeletal or muscle abnormalities prohibiting participation in an exercise training programme
Pretreatment: nil
Interventions Intervention characteristics
Exercise

  • Setting: inpatient

  • Components: "specialized respiratory and exercise training programme"

  • Training dose: frequency: cycle ergometry and walking daily, resistance training 5 x/week, 3 weeks

  • Training dose: duration: 10‐25 min/day cycle ergo, 60 mins walking/day, 30 mins respiratory training, light weights (500‐1000 g)

  • Training dose: intensity: commence at 60%‐80% of HR on CPET, progress as per individual tolerability and improvement

  • Intervention (mode): respiratory and exercise training programme as per Mereles 2006 ‐ interval training on cycle ergometer, walking, resistance training, respiratory training (PLB, body perception, yoga, respiratory muscle training)


Control

  • "Patients in the control group received a programme without specific exercise training."
Outcomes Morbidity ‐ adverse events
Disease progression
Precluded from training
6MWD
Identification Sponsorship source: this work was supported by the German National Research Agency (DFG): “Image‐based V/Q analysis” (FOR 474‐2)
Country: Germany
Setting: inpatient rehabilitation
Comments:
Author's name: Sebastian Ley
Institution: University Hospital Heidelberg
Email: ley@gmx.de
Address: Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Im Neuenheimer Feld 430,69120 Heidelberg, Germany
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomly assigned to either a training or a control group using a permuted block randomization procedure."
Allocation concealment (selection bias) Unclear risk The method of allocation was not specified.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unabel to blind participants or personnel due to the to intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Assessment of 6MWD and MR examination were performed by investigators who were blinded to the clinical data and group assignment of the patients. Evaluation of the MR data was done blinded to the clinical setting and in random order."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised patients were analysed
Selective reporting (reporting bias) Low risk Unclear whether trial was registered but reporting does not appear selective
Other bias Low risk