Determining Comparison of the effect of Throwers Ten Exercises and Modified Stretching Movements on fatigue intensity in patients with type 2 diabetes
Design
Clinical trial with control group, with parallel, randomized groups, 75 patients
Settings and conduct
Approval of the research plan in the ethics committee of the university vice chancellor for research. First, complete the demographic checklist and the Smets's Multidimensional Fatigue Inventory. The number of training sessions in the two groups of Throwers Ten Exercises and Modified Stretching Movements is 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 o'clock in the morning. Immediately after the sessions, the patients' fatigue severity will be re-evaluated using a Smets's Multidimensional Fatigue Inventory. The exercises will be performed at the patients' homes using a CD and a pamphlet prepared by the researcher.
Participants/Inclusion and exclusion criteria
Admission requirements: 1- Ability to communicate and answer questions 2- At least 6 months have passed since the diagnosis of type 2 diabetes by an endocrinologist. Conditions of non-entry: 1- Performing amputation in the arms and legs 2- Previous participation in studies similar to the current research
Intervention groups
Intervention group 1: Throwers Ten Exercises: These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 in the morning. Intervention group 2: Modified Stretching Movements: These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 in the morning. Control group: Non-intervention: This training group will not be given.
Main outcome variables
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210209050312N1
Registration date:2021-06-22, 1400/04/01
Registration timing:registered_while_recruiting
Last update:2021-06-22, 1400/04/01
Update count:0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
Mohammadreza Abbasipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3331 3426
Email address
mohamadreza.abasipour@yums.acu.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Throwers Ten Exercises and Modified Stretching Movements on fatigue intensity in patients with type 2 diabetes
Public title
Comparison of the effect of Throwers Ten Exercises and Modified Stretching Movements on fatigue intensity in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate and answer questions
Consent to participate in the study and sign the informed consent form
Age 30 to 60 years
At least 6 months have passed since the diagnosis of type 2 diabetes by an endocrinologist
Exclusion criteria:
Perform amputations on the arms and legs
Neurological illnesses such as (depression and schizophrenia) and taking psychiatric medications
Previous participation in studies similar to current research
Cervical disc, lumbar disc and orthopedic problems
Class 3 and 4 heart failure
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Random block properties will be assigned using the List Randomization site and the creation of different number of blocks between the three groups of intervention 1 (Throwers Ten Exercises), intervention 2 (Modified Stretching Movements) and control.
Using the site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) random blocks of different sizes and multiplied by 3 (9, 6, 3) will be created.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj, Shahid Motahari Blvd., Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
IR.YUMS.REC.1400.025
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E10-E11- E
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Fatigue
Timepoint
Patients' fatigue at the beginning of the study (before the intervention) and immediately after the start of the study
Method of measurement
Smets's Multidimensional Fatigue Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Throwers Ten Exercises: Exercises in this group include 10 exercises in the upper limbs, including hands - elbows - shoulders - wrists and arms in different directions, which will be in accordance with the principle of overload (holding time and number of hands) that these exercises include ; Diagonal pattern in the form of hand opening, external rotation around the waist, external rotation at shoulder level, shoulder distance from shoulder surface, raising the scapula (scissors), Sidelying, lying on the abdomen in a horizontal position and limbs from Body rotation, pressing presses, UPS pressure, Bicep Curl, wrist extension or opening, wrist, lying down open, diagonal pattern with hand bending, internal rotation around waist, internal rotation on surface Shoulders, lying on the abdomen in a horizontal position and keeping the hands away from the body 100 degrees, Elbow Extension, diagonal pattern opening and bending the hands, diagonal pattern bending and opening the arms, internal and external rotation Around the waist, internal and external rotation at shoulder level, in the abdomen, opening and bending the elbow, bending the wrist, wrist open downwards (opposite to the previous position) and external rotation to the abdomen. These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 o'clock in the morning.
Category
Rehabilitation
2
Description
Intervention group 2: Modified Stretching Movements: These movements should be gentle and regular, including; Triceps, sliding against the wall, spine rotation, squatting, elbows close to the knees while moving, lifting while walking, twisting one leg, stretching the thighs while standing, stretching the muscles behind the thighs with the help of Sitting posture, Twin leg stretching, Diagonal stretching of the thigh in standing position, Stretching of the back thigh muscles with the help of standing posture, Horseshoe stretching in the standing position, Stretching of the thigh in the supine position, Cross stretching of the back thigh muscles with the help of cross, Stretching Standing twin and horseshoe muscles, bending the pelvis while kneeling, stretching the muscles behind the thighs while lying down with a towel, and stretching the twin and standing horseshoe muscles. These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 o'clock in the morning.
Category
Rehabilitation
3
Description
Control group: Non-intervention: This training group will not be given.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fayaz-Bakhsh Hospital
Full name of responsible person
Mohammadreza Abbasipour
Street address
Next to Vitana factory, Khalij-e-Fars Blvd, Old Karaj road, Km 7, Tehran
City
Tehran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1379613541
Phone
+98 21 6626 8156
Fax
+98 21 6625 0743
Email
fayazbakhsh673@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Yasuj, Shahid Motahari Blvd., Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 3333 7230
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mohammadreza Abbasipour
Position
Master student of medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side 12, Enghelab Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581475581
Phone
+98 74 3331 3426
Email
bahmd626@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammadreza Abbasipour
Position
Master student of medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side 12, Enghelab Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581475581
Phone
+98 74 3331 3426
Email
bahmd626@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammadreza Abbasipour
Position
Master student of medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side 12, Enghelab Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581475581
Phone
+98 74 3331 3426
Email
bahmd626@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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