Protocol summary
-
Study aim
-
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
-
This study was conducted during the COVID pandemic time; We were at the beginning of a new peak of COVID, and according to the research supervisor, the number of weeks of interventions was decreased to six weeks, but the number of sessions per week increased to four. However, we reduced the number of weeks and increased the number of sessions per week recommended by the research supervisor to prevent encountering COVID pike and contamination of participants. Second, we removed the lung function based on the project supervisor because we had to use a spirometer mouth to measure lung function, and again the participants were likely to get coronavirus, so we removed the lung function.
The mentioned changes were reported to the university research committee and the project supervisor, but we were not informed about the update of the RCT site.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20190426043377N3
Registration date:
2021-05-22, 1400/03/01
Registration timing:
prospective
Last update:
2022-06-16, 1401/03/26
Update count:
1
-
Registration date
-
2021-05-22, 1400/03/01
-
Registrant information
-
-
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 Six Weeks of Water-based Stretching and Pilates Exercises on Pain, 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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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