The Effect of Eight Weeks Water-based Stretching and Pilates Exercises on Pain, Pulmonary Function, Spine Posture and Foot Pressure Distribution in Patients with Ankylosing Spondylitis
Comparing the effectiveness of Pilates exercises and stretching exercise in water on pain, pulmonary function, spine posture, quality of life, and distribution of plantar pressure in patients with ankylosing spondylitis.
Design
The study had three groups parallel to the control group and pre-test and post-test design, assessors blind, randomized phase 2 and, 45 patients. Random number allocation software is used for randomization
Settings and conduct
This study will be conducted at Razi university.
evaluators will be blinded in the study
The method of blinding will be done by randomization process by a person not involved in the study and placed the subjects' numbers in a sealed envelope.
Participants/Inclusion and exclusion criteria
no progression of the bamboo spine on radiographical scans,(2) Bath Ankylosing Spondylitis Disease Activity Index (BAS-DAI) of 4.0 points or lower, (3)lack of regular exercise for the last 6 months; (4) use of medication for the last 6 months.
Those with uncontrolled chronic diseases or psychiatric history and currently on psychiatric medication were excluded
Intervention groups
water-based Pilates exercise group
stretch-based exercise group
control
Main outcome variables
pain, spin posture, spine range of motion, foot pressure distribution.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190426043377N3
Registration date:2021-05-22, 1400/03/01
Registration timing:prospective
Last update:2021-05-22, 1400/03/01
Update count:1
Registration date
2021-05-22, 1400/03/01
Registrant information
Name
Farzaneh Gandomi
Name of organization / entity
دانشگاه رازی
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 3272
Email address
gandomi777@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eight Weeks Water-based Stretching and Pilates Exercises on Pain, Pulmonary Function, Spine Posture and Foot Pressure Distribution in Patients with Ankylosing Spondylitis
Public title
The Effect of Water-based Stretching and Pilates Exercises on Ankylosing Spondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No progression of the bamboo spine on radiographical scan
Bath Ankylosing Spondylitis Disease Activity Index (BAS-DAI) of 4.0 points or lower
Lack of regular exercise for the last 6 months
Use of medication for the last 6 months
Exclusion criteria:
Those with uncontrolled chronic diseases or psychiatric history and currently on psychiatric medication
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple individual randomization using Random Number Allocation software was used. The assignment sequence is hidden by the numbered envelopes, which are numbered sequentially, and the envelopes are opened only after all the initial and basic assessments of the participants have been made. The random assignment sequence is performed by one of the study partners who is not involved in the evaluations and remains secret from the evaluators and other research colleagues.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors do not know the assigned group of subjects; Because the assignment of individuals to groups is done by a person outside the research and after evaluating the pre-test, he introduces the assigned group to him.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah university of medical sciences
Street address
Shahid Beheshti Boulevard-Center No. 2
City
Kermanshah
Province
Kermanshah
Postal code
6715663137
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.KUMS.REC.1399.1137
Health conditions studied
1
Description of health condition studied
Ankylosing Spondylitis
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis
Primary outcomes
1
Description
Primary outcome: pain
Timepoint
Before and after 8-week
Method of measurement
Pain by the visual analog scale (VAS)
2
Description
Spine range of motion (ROM)
Timepoint
Before and after 8-week
Method of measurement
Spine range of motion by inclinometer
Secondary outcomes
1
Description
Spine posture
Timepoint
Before and after 8-week intervention
Method of measurement
Spine posture by Spinal mouse
2
Description
Foot pressure distribution
Timepoint
Before and after 8-week intervention
Method of measurement
Foot pressure distribution by PT scan
3
Description
Pulmonary Function
Timepoint
Before and after 8-week intervention
Method of measurement
Spirometry device
Intervention groups
1
Description
Intervention group: Pilates in water: Pilates in water training program includes 12 sessions in the shallow, semi-deep and deep part of Azadi pool in Kermanshah on even days, 3 sessions per week with water temperature of 28 to 29 degrees Celsius. Each training session is 60 minutes and includes the following: The correct way of abdominal breathing and the basic principles of the sessions, including the main physical exercises in different positions (standing, floating in two positions, arch and back) and with resistance bands ( TheraBand Elastic Band Hygienic Corporation, Akron, OH, USA) Combines training balls, rims, clamps attached to bars around the pool, steppe and wood.
Category
Rehabilitation
2
Description
Control group: medication; NSAIDs & Anti TNF (weekly, two weekly, and monthly)
Category
Treatment - Drugs
3
Description
Intervention group: Stretching exercise in water: The stretching program in water in this study includes 24 sessions of water exercise activity in the shallow part of Azadi pool in Kermanshah on even days, 3 sessions per week with water temperature of 33 to 30 degrees Celsius and intensity of exercise 50 Up to 75% of the maximum heart rate is performed. Each training session is 60 minutes, which is divided into 3 parts: 10 to 15 minutes of warm-up and 35-45 minutes of the main exercises. In general, the movements performed in this stage include a series of stretching movements, walking in directions. Jogging in water, upper limb movements while the lower limbs are immobile, lower limb movements while the upper limbs are fixed, and upper and lower limb movements will be performed simultaneously by the exercise instructor. The water is designed according to the condition and ability of patients according to the instructions of the American Physical Medicine Association.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
clinical research development center, Imam Reza Hospital
Full name of responsible person
Fatemeh Vafaei
Street address
bage-e- Abrisham- Imam Reza Hospital
City
kermanshah
Province
Kermanshah
Postal code
67 15663137
Phone
+98 83 3427 3270
Email
parvizsoufivand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Korush Hamzehei
Street address
Shahid Beheshti Boulevard Center number two
City
kermanshah
Province
Kermanshah
Postal code
6715663136
Phone
+98 83 3428 3270
Email
sdrc@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Razi Univesity
Full name of responsible person
Farzaneh Gandomi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries and Corrective Exercises
Street address
Razi University, Bagh-e- Abrisham Ave.
City
Kermanshah
Province
Kermanshah
Postal code
6715663137
Phone
+98 83 3428 3272
Email
gandomi777@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Farzaneh Gandomi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport injuries and corrective exercises
Street address
Razi Univesity, Bagh - e- Abrisham Ave.
City
Kermanshsh
Province
Kermanshah
Postal code
6715673136
Phone
+98 83 3428 3270
Email
gandomi777@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Farzaneh Gandomi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injuries and Corrective Exercises
Street address
Razi University, Bagh -e- Abrisham Ave.
City
Kermanshah
Province
Kermanshah
Postal code
6715663136
Phone
+98 83 3428 7032
Email
gandomi777@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available