Pulmonary rehabilitation in patients with mustard gas lung disease: a study protocol for a randomized controlled trial.
Chemical Warfare Agents
/ poisoning
Exercise Test
Exercise Therapy
/ adverse effects
Exercise Tolerance
Humans
Lung
/ drug effects
Lung Diseases
/ chemically induced
Muscle Strength
Mustard Gas
/ poisoning
Patient Education as Topic
Psychosocial Support Systems
Quadriceps Muscle
/ physiopathology
Quality of Life
Randomized Controlled Trials as Topic
Respiratory Function Tests
Time Factors
Chemical warfare
Mustard gas
Pulmonary rehabilitation
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
14 Feb 2019
14 Feb 2019
Historique:
received:
07
07
2018
accepted:
05
01
2019
entrez:
16
2
2019
pubmed:
16
2
2019
medline:
14
6
2019
Statut:
epublish
Résumé
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. 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. 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. Iranian Registry of Clinical Trials, IRCT2016051127848N1 . Registered on 24 May 2016.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
Iranian Registry of Clinical Trials, IRCT2016051127848N1 . Registered on 24 May 2016.
Identifiants
pubmed: 30764860
doi: 10.1186/s13063-019-3180-3
pii: 10.1186/s13063-019-3180-3
pmc: PMC6376791
doi:
Substances chimiques
Chemical Warfare Agents
0
Mustard Gas
T8KEC9FH9P
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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