In this study, we evaluate the effects of endurance and resistance exercise on changing of pain and also fat distribution in different parts of body. Patients, who are diagnosed as chronic low back pain, are divided in two groups randomly. Both groups receive one common protocol based on educational program. First group will receive common protocol with strengthening, and aerobic exercise and the other group will get common protocol with aerobic exercise. Common protocol includes educational program with core stability exercise (stretching exercise). All patients will be evaluated at first, three months and six months later. Assessments will be done in this manner: pain will be evaluated based on VAS, and fat distribution will be assessed with body mass analysis. All patients will be supervised every two weeks and their exercise will be progressed based on their fitness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103084251N4
Registration date:2011-12-26, 1390/10/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-26, 1390/10/05
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
dadgostar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-07-29, 1390/05/07
Expected recruitment end date
2012-12-05, 1391/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistance and endurance training on pain scale and fat distribution in patients with non specific low back pain
Public title
The effect of resistance and endurance training on pain scale and fat distribution in patients with non specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 to 70 years old; New episode of low back pain at least for 12 weeks; unable to do their daily activity at least three weeks. Exclusion criteria: Diagnosed as specific low back pain; history of trauma, infection, tumor, inflammatory diseases, Sciatica, surgery in last six months, diagnosed as cognitive disorder, pregnancy.
Age
From 20 years old to 70 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
Deputy of Research, Tehran University of medical sciences
Street address
4th floor of Tehran university centre, Ghods street, Keshavarz Blvd
City
Tehran
Postal code
1417653761
Approval date
2011-11-19, 1390/08/28
Ethics committee reference number
1763, 130, ص, 90
Health conditions studied
1
Description of health condition studied
change of pain in low back pain
ICD-10 code
M54.5
ICD-10 code description
low back pain
Primary outcomes
1
Description
Body mass index
Timepoint
6week after bariatric surgery and 3 month after surgery
Method of measurement
BMI = ( Weight in Kilograms / ( Height in Meters x Height in Meters ) )
Secondary outcomes
1
Description
muscle strength
Timepoint
after exercise training
Method of measurement
Digital handDaynamometer
2
Description
waist circumference
Timepoint
after exercise training
Method of measurement
by researcher during physical activity
Intervention groups
1
Description
First group: this group will be training aerobic exercise with common treatment protocole one session per two weeks.
Category
Lifestyle
2
Description
Group B: In addition to common treatment protocole, one sessions per two weeks for one hour strength training under the supervision of a medical specialist sports are doing.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports medicine clinic in Rasoule Akram hospital
Full name of responsible person
Haleh Dadgostar, MD
Street address
Hazrat Rasool Hospital, Niayesh Ave, Satarkhan Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Tehran university of medical sciences
Full name of responsible person
Dr Akbar Fotohi
Street address
4 th floor of Tehran medical university, Ghods street, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tehran university of medical sciences
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
Rasoule Akram hospital
Full name of responsible person
Haleh Dadgostar, MD
Position
Assistant professor
Other areas of specialty/work
Street address
Rasoule Akram Hospital, Niayesh Ave, Satarkhan Street
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Fax
+98 21 6651 6049
Email
hdadgostar@tums.ac.ir , hldadgostar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasoule Akram Hospital
Full name of responsible person
Haleh Dadgostar, MD
Position
Assistant professor
Other areas of specialty/work
Street address
Rasoule akram Hospital, Niayesh Ave, Satarkhan Street
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Fax
Email
hdadgostar@tums.ac.ir , hldadgostar@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)