Pulmonary rehabilitation in patients with mustard gas lung disease: a study protocol for a randomized controlled trial.

BACKGROUND

More than 60,000 people have health problems due to chemical weapons exposure during the Iran-Iraq war. Respiratory consequences of mustard gas exposure are common and disabling; medical interventions have limited effect. Patients complain of cough, sputum, breathlessness and exercise limitation. We hypothesized that patients with this condition would benefit from pulmonary rehabilitation.

METHODS

We outline the protocol for an assessor-blind, two-armed, parallel-design randomized controlled clinical trial (IRCT2016051127848N1). Sixty patients with respiratory disease due to documented sulfur mustard gas exposure will be randomized to either take part in a 6-week pulmonary rehabilitation programme or receive usual care. Inclusion criteria include forced expiratory volume in 1 second < 80% predicted and Medical Research Council dyspnoea score ≥ 3. The primary endpoint will be the change in cycle endurance time at 70% baseline exercise capacity at 6 weeks. Lung function, physical activity, the strength and endurance of the quadriceps muscle, and quality of life will also be compared. Outcomes will be assessed at 6 weeks and 12 months. Health care utilization will also be assessed.

DISCUSSION: If the study confirms that rehabilitation is effective for patients with mustard gas lung disease this should prompt provision of the intervention to this patient group.

TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT2016051127848N1 . Registered on 24 May 2016.