A single blind randomized clinical trial to evaluate the effect of group training and supervised group exercise in patients with ankylosing spondylitis
Comparison of therapeutic efficacy of group training and supervised group exercise with routine treatments in patients with ankylosing spondylitis referred to Imam Khomeini Hospital Physical Medicine and Rehabilitation Clinic
Design
A randomized clinical trial with a sample size of 45 individuals and a single blinded and random number generator software will be used. This software generates a random number for each patient.
Settings and conduct
This study is a randomized clinical trial performed on patients with ankylosing spondylitis referred to Imam Khomeini Hospital Physical Medicine and Rehabilitation Clinic. Patients are divided into three equal and random groups. This study is a single blind study and the symptom assessor and the data analyzer will be unaware of the type of intervention performed for each patient.
The first and second groups receive a two-hour training session on the disease and lifestyle according to the information in the manual by a trained physical medicine and rehabilitation specialist. The first group will then be supervised by a trained physiotherapist for 12 months for 12 one-hour sessions of exercise therapy. Patients are advised to continue their exercise program at home as much as possible.
The second and third groups continue their usual treatments and are advised to do the exercises in the booklet at least three days a week for one hour each month.
Participants/Inclusion and exclusion criteria
definite diagnosis of Ankylosing spondylitis
Intervention groups
patients under 12 sessions of exercise therapy under the supervision of a skilled physiotherapist
Main outcome variables
Visual analogue scale (VAS), Questionnairs : Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), Bath Ankylosing Spondylitis Functional Index(BASMI)، Ankylosing Spondylitis Disease Activity Score(ASDAS) and Evaluation of ankylosing spondylitis quality of life(EASiQoL).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191015045119N2
Registration date:2020-05-06, 1399/02/17
Registration timing:registered_while_recruiting
Last update:2020-05-06, 1399/02/17
Update count:0
Registration date
2020-05-06, 1399/02/17
Registrant information
Name
Maryam Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6619 2291
Email address
m_hosseini100@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A single blind randomized clinical trial to evaluate the effect of group training and supervised group exercise in patients with ankylosing spondylitis
Public title
Effect of education and exercise in patient with Ankylosing Spondylitis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The definitive diagnosis of Ankylosing Spondylitis in the age group of 18 to 65 years.
Exclusion criteria:
Cardiovascular Diseases such as Uncontrolled Blood Pressure, Vascular Aneurysms or Other Physical Activity Restrictions
Absolute or relative contraindication for exercise
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block randomization. The following code is written on separated papers and dumped into the container. A paper will be taken for the patient who enters the clinic and the assignment of the next 6 patients will be specified.
AABBCC
BBAACC
BBCCAA
CCBBAA
CCAABB
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will be unaware of the intervention performed for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biological Research
Street address
Imam Khomeini Hospital, Dr.Gharib Street, at the end of Keshavarz Boulevard
Bath Ankylosing Spondylitis Disease Activity Index questionnaire
4
Description
patients quality of life
Timepoint
1month, 2months, 6months
Method of measurement
Evaluation of Ankylosing Spondylitis Quality of Life questionnaire
5
Description
patients functional ability
Timepoint
1month, 2months, 6months
Method of measurement
Bath Ankylosing Spondylitis Functional Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: 15 people receiving a booklet, attending a disease training session and explaining the booklet and 12 sessions of exercise therapy supervised by a trained physiotherapist
Category
Rehabilitation
2
Description
Intervention group2: 15 people receiving a booklet, attending a disease training session and explaining the booklet
Category
Rehabilitation
3
Description
intervention group3: 15 people receiving a booklet
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Doctor Maryam Hoseini
Street address
Bagherkhan street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0111
Email
imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraian MD
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6670 6142
Fax
+98 21 6670 6141
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?