Determining and comparing the effect of tai chi exercise and walking on HbA1C levels health related quality of life in patient with type 2 diabetes
Design
Clinical trial with control group, with parallel, randomized groups, 96 patients
Settings and conduct
Approval of the research plan in the university ethics committee. At the beginning of the study, completion of the checklist of demographic characteristics, Diabetes Quality of Life-Brief Clinical Inventory and analysis of HbA1C level with HPLC model DS5. Intervention in both tai chi and walking groups, 60 minutes and for 12 weeks. 12 weeks after the start of the study, re-completion of the Diabetes Quality of Life-Brief Clinical Inventory and analysis of HbA1C level with HPLC model DS5. The training place is a gym.
Participants/Inclusion and exclusion criteria
Admission requirements: 1- Willingness to participate in the study 2- Age 20-60 years. Conditions of non-entry: 1- Diabetic foot ulcer 2- Lack of regular participation in exercises
Intervention groups
Intervention group 1: tai chi exercise: This exercise is performed for 12 weeks (1 to 2 hours after eating). Subjects will participate in two 60-minute Tai Chi training sessions per week for 12 weeks. Each session will include 10 minutes of warm-up, 40 minutes of tai chi and 10 minutes of cooling down. Intervention group 2: walking: This exercise is performed for 12 weeks (1 to 2 hours after eating). Each session will include 10 minutes of warm-up and 10 minutes of cool-down. Control group: Non-intervention: This training group will not be given.
Main outcome variables
Hemoglobin A1C and Health related quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220713055466N1
Registration date:2022-07-18, 1401/04/27
Registration timing:prospective
Last update:2022-07-18, 1401/04/27
Update count:0
Registration date
2022-07-18, 1401/04/27
Registrant information
Name
Maryam Layeghi Motlagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 4721
Email address
maryam.layeghi93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of tai chi exercise and walking on HbA1C levels health related quality of life in patient with type 2 diabetes
Public title
Comparison of the effect of tai chi exercise and walking on HbA1C levels health related quality of life in patient with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes with the approval of a specialist doctor
Treated with oral diabetes medications
Willingness to participate in the study
Awareness of your illness
being alert
Not suffering from mental retardation and not suffering from mental illness
Age 20-60 years
Obtaining an average and unfavorable quality of life score related to health based on a questionnaire
Exclusion criteria:
Hospitalization during the study
Creating emergency conditions such as non-ketonic hyperosmolar or hypoglycemia
Patients with decreased visual activity due to diabetic retinopathy and decreased body movement due to diabetic foot disease
Unwillingness to continue cooperation
Migration
Exercise intolerance
Diabetic foot ulcer
Suffering from musculoskeletal or cardiovascular diseases
Lack of regular participation in exercises
Diabetic patients with hemoglobinopathy or anemia
Diabetic patients with uremia
Diabetic patients with microvascular complications such as retinopathy, nephropathy and neuropathy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation by block method will be in order for the researcher to make sure that exactly the same number of patients will enter the intervention and control groups in a consecutive, but equal, time interval. The groups will be formed as B, A and C. Before assigning people to one of the groups, a list of these letters (B, A, and C), in other words, blocks of sizes 3, 9, and 12, will be created by the reliable website https://www.sealedenvelope.com. Each of the referring and qualified people will be assigned to one of the groups.
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 University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-05-18, 1401/02/28
Ethics committee reference number
IR.YUMS.REC.1401.022
Health conditions studied
1
Description of health condition studied
Patient with type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1C
Timepoint
Hemoglobin A1C level of patients at the beginning of the study (before the intervention) and 12 weeks after the study.
Method of measurement
Analysis with HPLC model DS5
2
Description
Health related quality of life
Timepoint
The level of Health related quality of life of patients at the beginning of the study (before the intervention) and 12 weeks after the study.
Method of measurement
Diabetes Quality of Life-Brief Clinical Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: tai chi exercise: This exercise is performed for 12 weeks (1 to 2 hours after eating). Subjects will participate in two 60-minute Tai Chi training sessions per week for 12 weeks. Each session will include 10 minutes of warm-up, 40 minutes of tai chi and 10 minutes of cooling down. warm up includes; Exercise major joints and muscle groups at a low intensity level to prepare the skeletal muscles, heart and lungs for a gradual increase in exercise intensity following the recommendation of the American Diabetes Association. During each session, in addition to gentle, coordinated and smooth movements of different body parts, relaxation and deep breathing will be emphasized during the exercise. A tai chi workout will be followed by a cool-down workout that is structured like a warm-up to gradually lower the heart rate to pre-exercise levels. Because tai chi involves significant footwork, participants are advised to take precautions to prevent blisters and keep feet dry to minimize foot injury, as recommended by the American Diabetes Association. Recommends. Participants will also be reminded to drink enough water before, during and after exercise, as dehydration can negatively affect blood glucose levels and heart function. To prevent dehydration due to the heat caused by the activity, the gym will have air conditioning. Also, precautions such as eating a snack before exercise will be taken to prevent hypoglycemia caused by exercise. Participants will be advised to notice and report symptoms such as hunger, nervousness, tremors, or sweating. Glucose tablets, juice, soft drinks will be provided to increase blood glucose if needed. In addition, brochures and educational CDs will be given.
Category
Lifestyle
2
Description
Intervention group 2: walking: This exercise is performed for 12 weeks (1 to 2 hours after eating). Each session will include 10 minutes of warm-up and 10 minutes of cool-down. warm up includes; Exercise major joints and muscle groups at a low intensity level to prepare the skeletal muscles, heart and lungs for a gradual increase in exercise intensity following the recommendation of the American Diabetes Association. Participants will be reminded to drink enough water before, during and after exercise, as dehydration can negatively affect blood glucose levels and heart function. To prevent dehydration due to the heat caused by the activity, the gym will have air conditioning. Also, precautions such as eating a snack before exercise will be taken to prevent hypoglycemia caused by exercise. Participants will be advised to notice and report symptoms such as hunger, nervousness, tremors, or sweating. Glucose tablets, juice, soft drinks will be provided to increase blood glucose if needed. In addition, the relevant brochure will be given.
Category
Lifestyle
3
Description
Control group: Non-intervention: This training group will not be given.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Maryam Layeghi Motlagh
Street address
Shahid Beheshti Hospital, Shahid Montazeri Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591719154
Phone
+98 74 3322 4721
Fax
+98 74 3322 1811
Email
beheshtihospital@yasooj.ir
2
Recruitment center
Name of recruitment center
Martyr Dr. Jalil Hospital
Full name of responsible person
Maryam Layeghi Motlagh
Street address
Martyr Dr. Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
maryam.layeghi93@gmail.com
3
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Maryam Layeghi Motlagh
Street address
Imam Sajjad Hospital, Next to Hotel Azadi, Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591719154
Phone
+98 74 3322 0166
Email
maryam.layeghi93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
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
Maryam Layeghi Motlagh
Position
Msc student in Medical-Surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 51, Shahid 1 Alley., 30 meters from Maad Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591719154
Phone
+98 74 3322 4721
Email
maryam.layeghi93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Layeghi Motlagh
Position
Msc student in Medical-Surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 51, Shahid 1 Alley., 30 meters from Maad Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
یاسوج
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591719154
Phone
+98 74 3322 4721
Email
maryam.layeghi93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Layeghi Motlagh
Position
Msc student in Medical-Surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 51, Shahid 1 Alley., 30 meters from Maad Ave., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591719154
Phone
+98 74 3322 4721
Email
maryam.layeghi93@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