Nield 2012.
Study characteristics | ||
Methods |
Study design: single‐centre, open‐label, parallel randomised controlled trial in the USA Duration: 12 weeks Setting: secondary care |
|
Participants |
Population: 22 adults recruited from West Los Angeles VA Healthcare Center Baseline characteristics: mean age 65 years, male: 100%, current smokers (n): 11/22, FEV1 (% predicted): 56, concomitant medications: not reported Inclusion criteria: age > 45 years; FEV1/FVC < 70%, predicted FEV1/FVC < 80% with no reversibility after inhaled bronchodilator, SOB score ≥ 3 when walking (MMRC chronic dyspnoea questionnaire) Exclusion criteria: hospital admission in last four weeks, change of bronchodilator therapy in last two weeks |
|
Interventions | Measurements taken at baseline, 4 weeks and at a 12 week follow‐up Treatment arms:
|
|
Outcomes |
|
|
Notes |
Funding: Breathe California of Los Angeles County, National Institutes of Health Other identifiers: NCT01161290 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported as randomised, no further information about the process |
Allocation concealment (selection bias) | Unclear risk | Staff member who allocated the numbers was not related to the study, but it was unclear if the numbers were concealed or not |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No further information, but blinding would not be possible due to the nature of the treatment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No further information, but subjective outcomes likely to be high risk of bias as these are self‐reported assessments by participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar number of participants lost to follow‐up, 2 more in the intervention group compared to the control group |
Selective reporting (reporting bias) | High risk | SDs were not reported for outcomes assessed, so calculated from SE. The results for Borg scale was not reported, and nether was the shortness of breath questionnaire. No registration details found online |
Other bias | Low risk | None identified |