Evaluation of Pulmonary rehabilitation effects on skeletal muscle condition, pulmonary function and quality of life in victims of chemical warfare

We hypothesise that, as is the case in COPD patients, pulmonary rehabilitation will improve the health of this patient group.

We outline the protocol for an assessor blind, two-armed, parallel-design randomized controlled clinical trial

The pulmonary rehabilitation, trial activities and other clinical services will be delivered in Tehran’s Khatam-ol-Anbia Hospital. This hospital is a sub-specialized centre equipped with specialized personnel and advanced equipment including a cardio-pulmonary rehabilitation hall.

The participants are chemical warfare victims who have been exposed to mustard gas, residing in Tehran and its suburbs with symptomatic lung disease. Inclusion criteria include, FEV1 < 80%, MRC dyspnoea score ≥ 3 . Exclusion criteria; 1) any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis, 2) any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases, 3) the presence of other non-chemical related pulmonary diseases like asthma, 4) active malignancy 5) severe cognitive disorder and psychiatric disease that is associated with memory disorder.

In addition to the usual treatment, the intervention group will receive pulmonary rehabilitation services. The pulmonary rehabilitation intervention will include a combination of physical exercises, educational programs and psychosocial support. The physical exercises will include endurance and strength components tailored to each individual’s conditions. Both the upper and lower limbs will be exercised, though with greater emphasis on the legs

Primary endpoint will be change in cycle endurance time at 70% baseline exercise capacity at six weeks

Foundation of Martyrs and Veterans Affairs

After selecting the participants according to the inclusion and exclusion criteria, baseline assessments will be performed .The participants will be randomized into two control and intervention groups. The random sequence will be determined from the randomization website (http://www.jerrydallal.com/random/permute.htm) in blocks of four

The technicians who are responsible for randomization , the assessors and the safety committee and data monitoring are blind to the study.The two groups are identified by letters A and B. In order to protect confidentiality in all stages of the trial, each participant will be assigned a unique identification code.

The total potential data can be shared after unidentifiable people.

The start of the access period is one year after the publication of the results.

Data will only be available to researchers in universities and scientific centers .

Applicants must announce their goals and plans on how to use the data to be decided on by case basis.

Janbazan Medical and Engineering Research Center (JMERC), NO.17, Farrokh St., Moghaddas Ardebily Ave., Chamran Highway, Tehran, Iran Tehran Iran Phone: +98 2122415367 Fax: +98 2122418180 http://www.jmerc.ac.ir

The request is submitted to the supervisor through JMERC. In case of initial agreement, the Reaserch Committee will make the final decision.