This is a single-blind randomized clinical trial to Evaluate the Pulmonary rehabilitation effects on skeletal muscle condition, pulmonary function and quality of life in victims of chemical warfare. The patients suffer from chronic lung complications such as respiratory symptoms as well as some degree of lung injury in spirometry. Duration of the study is one year and the first 6 weeks are assigned to pulmonary rehabilitation program. The patients are allocated to intervention or control group. Medical assessments in both groups will be repeated three times: Baseline, the end of the six week rehabilitation program and at the end of the study. Medical evaluation includes physical examination, bodyplethysmography, DL CO, ergospirometry, measurement of strength and endurance of quadriceps muscle, 6MWT, body composition analysis, SGRQ questionnaire and HADS questionnaire.
Patients will attend 3 times per week for 6 weeks in outpatient pulmonary rehabilitation program. The rehabilitation program includes physical exercises and patient education. The control group will receive their usual treatment in the same time. The patients are questioned in terms of exacerbation and lung complications leading to hospitalization as well as drug consumption monthly during the year.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051127848N1
Registration date:2016-05-24, 1395/03/04
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-05-24, 1395/03/04
Registrant information
Name
Mohamad Reza Sedighi Moghadam
Name of organization / entity
Chemical Warfare Victims Affairs Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8830 7246
Email address
drmoghaddam@jmerc.ac.ir
Recruitment status
Recruitment complete
Funding source
Foundation of Martyrs and Veterans Affairs
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Pulmonary rehabilitation effects on skeletal muscle condition, pulmonary function and quality of life in victims of chemical warfare
Public title
Pulmonary rehabilitation in chemical victims
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
-Sulfur mustard exposure
-moderate and severe lung disease, according to Gold classification
-The Medical Research Council dyspnoea score > or = 3
Exclusion criteria:
-Conditions which would interfere with the patient’s ability to participate in the rehabilitative process (such as disabling arthritis)
-Conditions which might place the patient at risk during exercise training (such as uncontrolled cardiac disease)
-Other pulmonary disease such as coexisting asthma
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Committee of Ethics in Biomedical Research Foundation of Martyrs and Veterans Affairs
Street address
No 17,Farokh Street,Moghadas Ardebili Street
City
Tehran
Postal code
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
87-E-R-102
Health conditions studied
1
Description of health condition studied
chronic respiratory disorders due to sulfur mustard inhalation
ICD-10 code
J68.4
ICD-10 code description
Chronic respiratory conditions due to chemicals, gases, fumes and vapors
Primary outcomes
1
Description
Endurance Time
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using an electronically braked cycle ergometer at 70% of Wmax to volitional exhaustion
Secondary outcomes
1
Description
Lung flows and volumes
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using body plethysmography
2
Description
single-breath diffusing capacity
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using DLCO
3
Description
Vo2max
Timepoint
before intervention
Method of measurement
by using ergospirometry
4
Description
Quadriceps muscle strength
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Biodex: Participants will perform 30 sequential volitional maximal contractions at an angular velocity of 90°/s, while seated upright and with the hip joint in 90° of flexion. Quadriceps muscle strength was defined as the highest peak torque (Newton-meter (Nm)).
5
Description
AT
Timepoint
before intervention
Method of measurement
by using ergospirometry
6
Description
O2 pulse
Timepoint
before intervention
Method of measurement
by using ergospirometry
7
Description
Quadriceps muscle endurance
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Biodex: Participants will perform 30 sequential volitional maximal contractions at an angular velocity of 90°/s, while seated upright and with the hip joint in 90° of flexion. Quadriceps muscle endurance was defined as the total amount of delivered work (Joules (J)) during the set of 30 repetitions
8
Description
Cross-sectional area of the rectus femoris (RFCSA)
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by Cross-sectional area of the rectus femoris (RFCSA) will be measured by B-mode ultrasonography using an 8 MHz 5.6 cm linear transducer, similar to the method of de Bruin et al
9
Description
FFM
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using single-frequency BIA (Bioelectrical Impedance Analyser)
10
Description
BMI
Timepoint
before intervention , 6th week, 12th month
Method of measurement
weight(kg)/height^2(m^2)
11
Description
Total distance walked during 6 minutes
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using 6MWT
12
Description
Anxiety and Depression
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using HADS
13
Description
quality of life
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using SGRQ
14
Description
Number of exacerbations (defined as episodes of increased respiratory symptoms requiring a change in medication)
Timepoint
monthly
Method of measurement
by asking the patient
15
Description
Number of hospitalization due to respiratory diseases
Timepoint
monthly
Method of measurement
by asking the patient and reviewing medical records
16
Description
GH
Timepoint
before intervention
Method of measurement
Lab Test
17
Description
IGF-1
Timepoint
before intervention
Method of measurement
Lab Test
18
Description
high sensitivity CRP
Timepoint
before intervention
Method of measurement
Lab Test
19
Description
Testosterone
Timepoint
before intervention
Method of measurement
Lab Test
20
Description
distance of daily walking
Timepoint
a week before intervention, 7th week and 12th month
Method of measurement
by using pedometer
21
Description
healthcare utilisation
Timepoint
at the end of study
Method of measurement
according to medical records
22
Description
dyspnea
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Borg Scale
23
Description
fatigue
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Borg Scale
Intervention groups
1
Description
Intervention: Pulmonary rehabilitation will be a mix of aerobic endurance training and strength training as well as education in self management. Patients will attend 3 times per week for 6 weeks.
Category
Rehabilitation
2
Description
Control: usual treatment without any additional intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Ol Anbia Hospital
Full name of responsible person
Iraj Arabi MD.
Street address
Khatam Ol Anbia Hospital, Rashid Yasemi Street, Above Mirdamad Blvd, Vali-Ye-Asr St.
City
Tehran
2
Recruitment center
Name of recruitment center
Sasan Hospital
Full name of responsible person
Ali Tavakoli Mehrgerdi MD.
Street address
No 43, Keshavarz Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Health Department of Foundation of Martyrs and Veterans Affairs
Full name of responsible person
Abd ol Reza Abbaspour MD.
Street address
Talebial Alley, Taleghani Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Health Department of Foundation of Martyrs and Veterans Affairs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Janbazan Medical Engineering Research Center
Full name of responsible person
Mohamad Reza Sedighi Moghadam MD. MPH
Position
researcher/general practitioner /MD. MPH
Other areas of specialty/work
Street address
No 17,Farokh Street,Moghadas Ardebili Street
City
Tehran
Postal code
Phone
+98 21 2241 5367
Fax
Email
moghadam_office@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pateur Institute of Iran
Full name of responsible person
Mostafa Ghanei MD.
Position
Head of Institute, pulmonologist
Other areas of specialty/work
Street address
12th Frvardin Street, Enghelab Square
City
Tehran
Postal code
Phone
+66 954321
Fax
Email
mghaneister@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Janbazan Medical Engineering Research Center
Full name of responsible person
Mohamad Reza Sedighi Moghadam MD. MPH
Position
researcher/general practitioner /MD. MPH
Other areas of specialty/work
Street address
No 17,Farokh Street,Moghadas Ardebili Street
City
Tehran
Postal code
Phone
+98 21 2241 5367
Fax
Email
moghadam_office@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)