The effect of exercises with Therabands and core stability on back pain and quality of life in patients with chronic renal failure undergoing peritoneal dialysis
Determining the effect of eight weeks of central stability exercises with stretch band on back pain and quality of life of peritoneal dialysis patients
Design
A clinical trial work with a control group with parallel groups without blinding and randomized with a table of random numbers with 30 patients.
Settings and conduct
In this research, the subjects are selected from the patients undergoing peritoneal dialysis after being called and invited to participate in Khurshid peritoneal dialysis center located in Isfahan city, according to the criteria for entering the research and with the approval of expert doctors. In this plan, the candidates will get acquainted with the type of study and the purpose of the work, the possible benefits and risks, and they will be randomly assigned to one of the two intervention (exercise) or control groups. Each of the subjects signed a written informed consent before being assigned to the groups. For 8 weeks, the intervention group performs the training program at home with the simultaneous supervision of the trainer online, 3 sessions per week. Tests are taken from people before the start of the exercise period and two times after the start of the exercise
Participants/Inclusion and exclusion criteria
People undergoing peritoneal dialysis for at least 3 months who agree to participate in the study and have chronic back pain are included in the study, and patients who are medically prohibited from exercising are excluded.
Intervention groups
The intervention group performs the training program online for 8 weeks and 3 sessions at home with the same supervision as the trainer. These exercises are taught face-to-face in the first week. From the control group, participants wanted to continue their usual physical activities as well as their usual treatment plans.
Main outcome variables
Low back pain and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200819048461N3
Registration date:2023-01-09, 1401/10/19
Registration timing:prospective
Last update:2023-01-09, 1401/10/19
Update count:0
Registration date
2023-01-09, 1401/10/19
Registrant information
Name
Mohammad ali Tabibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3230 1795
Email address
m.tabibi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercises with Therabands and core stability on back pain and quality of life in patients with chronic renal failure undergoing peritoneal dialysis
Public title
Effect of exercise in Peritoneal dialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
More than 3 months of peritoneal dialysis experience
Having chronic back pain
The permission of the attending physician to practice
No history of heart attack or stroke in the last 3 months
Able to walk without assistance (assistive devices such as canes and walkers are allowed).
Exclusion criteria:
Unstable blood pressure
Changing the type of dialysis
Uncontrolled arrhythmias
Congestive heart failure
Having severe musculoskeletal pain at rest or minimal activity
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual with random number generation program
Randomization was performed by a biostatistician using a computer-generated randomization program [using Stata 16, StataCrop, College Station, Tx] with an allocation ratio of 1:1.
For allocation concealment, allocation information will be protected in opaque sealed envelopes by an identified individual not participating in the study. Only after participant registration and baseline measurements are completed will envelopes be opened.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, it is not plausible to blind participants and study staff
who enroll participants and monitor the intervention delivery.
Research project collaborator who is blinded to
study arm assignments will obtain outcome measurements of the functional test and abnormalities. Outcome
adjudicators, and data analysts will be kept blinded to the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University of Medical Sciences
Intervention group: Intervention group: The experimental group will do 3 sessions of 30-minute exercise program at home for 8 weeks with the simultaneous supervision of the trainer online. These exercises are taught face-to-face in the first week. The training program will include general body warm-up (5 minutes), central stability exercises and general body cooling (10 minutes). After each exercise, a 30 to 60 second rest is given to the patient. Resistance exercises will be done with body weight, special bands, dumbbells, ankle and wrist weights
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Shahrzad Shahidi
Street address
No. 105, Ostandari Street,Esfahan
City
Esfahan
Province
Isfehan
Postal code
8135673381
Phone
+98 31 3222 2127
Email
Shahidi_shahrzad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pardis Specialized Wellness Institute
Full name of responsible person
Dr Mohamad Ali Tabibi
Street address
71 Alley. Jey Street
City
Esfahan
Province
Isfehan
Postal code
8156135414
Phone
+98 913 318 4624
Email
m.tabibi@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pardis Specialized Wellness Institute
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Pardis Specialized Wellness Institute
Full name of responsible person
Dr Mohammad Ali Tabibi
Position
Assistant professor of exercise physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
71 Alley, Jey Street Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174757536
Phone
031335252020
Email
m.tabibi@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pardis Specialized Wellness Institute
Full name of responsible person
Dr Mohammad Ali TabibI
Position
Assistant professor of exercise physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
71 Alley, Jey Street, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174757536
Phone
031335252020
Email
m.tabibi@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Pardis Specialized Wellness Institute
Full name of responsible person
Dr Mohammad Ali Tabibi
Position
Assistant professor of exercise physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
71 Alley, Jey Street, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174757536
Phone
031335252020
Email
m.tabibi@ut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study group are made available
When the data will become available and for how long
After October 2023
To whom data/document is available
Only academics are allowed
Under which criteria data/document could be used
If the data is used for the purpose of research in the field of variables and providing new solutions, it can be used by mentioning the source
From where data/document is obtainable
Dr. Mohammad Ali Tabibi via email address m.tabibi@ut.ac.ir
What processes are involved for a request to access data/document
It will be answered within one month after receiving the email