Chan 2013.
Methods |
Study design: RCT Study grouping: Parallel group |
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Participants |
Baseline characteristics Exercise training
Control
Included criteria: Quote "Patients with World Health Organization (WHO) group 1 PH were recruited from local outpatient clinics and enrolled between September 2009 and October 2011. Men and women were eligible if they were between 21 and 82 years of age, had PH diagnosed by a resting mean pulmonary arterial pressure ≥ 25 mm Hg as measured by right‐sided heart catheterization, were on stable PH therapies for at least 3 months, were sedentary, and had no pulmonary rehabilitation for 6 months prior to enrolment". Excluded criteria: Quote "To avoid “ceiling” or “floor” effects, patients were excluded if they were classified ed as WHO and New York Heart Association (NYHA) functional class I and could walk 400 m during a 6MWT, or classified as functional class IV and could not walk 50 m during a 6MWT. Additional exclusion criteria included FEV1 /FVC ratio ≤ 65%; history of ischaemic heart disease; ejection fraction < 40%; documented pulmonary capillary wedge pressure ≥ 18 mm Hg; significant hepatic, renal, or mitochondrial dysfunctions; severe psychiatric disease; use of medications that may limit exercise capacity or ability to adapt to exercise training; antiretroviral therapies; illicit drugs; tobacco use; or pregnancy". Pretreatment: Control group had worse lung function |
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Interventions |
Intervention characteristics Exercise training
Control
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Outcomes | 6MWD VO2peak 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: Physical summary score (SF‐36) HRQoL: Mental summary score (SF‐36) HRQol (CAMPHOR): Symptoms HRQol (CAMPHOR): Activities HRQol (CAMPHOR): QoL NYHA Class |
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Identification | This work was supported by the US National Institutes of Health (Intramural Funds 1 Z01 CL060068‐05 CC) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients who enrolled in the protocol were sequentially assigned subject numbers that randomly corresponded to a group receiving concurrent patient education plus aerobic exercise training (EXE) or to a group that received only the patient education portion of the regimen (EDU)." |
Allocation concealment (selection bias) | Unclear risk | Not specified. Quote " Following the baseline evaluations, patients were informed of the group to which they were randomly assigned" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Study personnel were blind to the randomization of patients during all baseline evaluations." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Investigators administering the CPET, 6MWT, and questionnaires were blind to randomization at baseline." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "criterion (Fig. 1). All 29 of these patients performed base‐ line testing. Based on their test responses, two of these patients were required to obtain additional medical clearance prior to beginning the intervention. One patient declined further participation while the other patient was cleared for participation and subsequently assigned a new subject number upon re‐entry into the protocol. This patient was originally assigned a subject number corresponding to EXE, but at re‐entry the randomization procedure resulted re‐assignment to EDU. As such, 28 patients in total participated in either the EXE or EDU groups (Fig. 1). Of the 14 patients allocated to the EXE group, two patients withdrew due to changes in medication and one withdrew due to low attendance at the exercise sessions. One patient in the EDU group was withdrawn from the study due to medication changes." |
Selective reporting (reporting bias) | High risk | Comment: Trial protocol at clinicaltrials.gov states that they were also going to collect IPAQ, stages of exercise change, exercise self efficacy, profile of mood states and near infrared spectroscopy |
Other bias | Low risk |