Objective: The effect of 8 weeks of aerobic and resistance training on body composition, perceived exertion fatigue and improve muscle strength in patients with sarcoidosis
Study design: Randomized, double-blind, phase II trial
Study population: all patients referred to the rehabilitation unit of Masih daneshvari hospital with pulmonary sarcoidosis.
inclusion criteria: patients with pulmonary sarcoidosis; Complaints of fatigue or shortness of breath during activities; Residence in Tehran
Exclusion criteria: coronary heart disease; retinal involvement; oxygen dependence in rest; Orthopedic disorders; The reluctance of patients to participate in the study; Unstable metabolic diseases.
Sample size: 30 subjects (15 patients in each group).
Intervention or interventions studied: In both groups of patients, standard medical treatment was prescribed by pulmonologist. Subject in control group prescribed to do aerobic and resistive exercise daily without the supervision of a researcher. In the intervention group supervised aerobic and resistance exercise twice a week for 45 minutes at pulmonary rehabilitation unit f Masih daneshvari hospital.
The primary outcome or consequences of the study: the percentage of body fat mass; quality of life score; Fatigue score
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081729405N1
Registration date:2016-09-28, 1395/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-28, 1395/07/07
Registrant information
Name
Shahram Kharabian Masouleh
Name of organization / entity
Masih Daneshvari Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2035
Email address
shahramkharabian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of 8 weeks of combined aerobic and resistive exercise on fat percentage, quality of life and fatigue in patients with pulmonary sarcoidosis
Public title
Effects of 8 weeks of combined aerobic and resistive exercise on fat percentage, quality of life and fatigue in patients with pulmonary sarcoidosis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients with pulmonary sarcoidosis; Complaints of fatigue or shortness of breath during activities; Residence in Tehran
Exclusion criteria: coronary heart disease; retinal involvement; oxygen dependence in rest; Orthopedic disorders; The reluctance of patients to participate in the study; Unstable metabolic diseases
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization according to block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Medical University
Street address
6th Floor, Bldg No.2 Shahid beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Postal code
Approval date
2015-11-10, 1394/08/19
Ethics committee reference number
IR.SBMU.NRITLD.REC.1394.169
Health conditions studied
1
Description of health condition studied
Sarcoidosis
ICD-10 code
D86.0
ICD-10 code description
Pulmonary sarcoidosis
Primary outcomes
1
Description
Body fat percent
Timepoint
Before and immediately after intervention
Method of measurement
with body composition instrument
Secondary outcomes
1
Description
Saint George quality of life score
Timepoint
Before and immediately after intervention
Method of measurement
standard farsi questionnaire
2
Description
Fatigue score
Timepoint
Before and immediately after intervention
Method of measurement
Fatigue Severity Scale
Intervention groups
1
Description
Intervention group: medication and two sessions per week supervise aerobic and resistive exercise in hospital rehabilitation unit
Category
Rehabilitation
2
Description
Control group: medication and exercise education
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
National research institute of tuberculosis and lung diseases
Full name of responsible person
Saba karimzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti Medical University
Full name of responsible person
Afshin Rezghi
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post code: 198396-3113
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti Medical University
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
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Shahram Kharabian Masouleh
Position
Sports and exercise medicine spesialist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2712 2035
Fax
Email
drshahramkh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Shahram kharabian masouleh
Position
Sports and exercise medicine specialist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2712 2035
Fax
Email
drshahramkh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Shahram kharabian masouleh
Position
Sports and exercise medicine specialist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2712 2035
Fax
Email
drshahramkh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)