this study aimed to assess the effect of regular exercise on achieving optimal HbA1c levels and its impact on cardiovascular risk factors, as measured by parameters such as the lipid profile
Design
This study utilized a randomized controlled design to assess the effects of exercise training on HbA1c levels and lipid profiles in patients with type 2 diabetes. The study was conducted among 80 patients who were allocated into two groups: 40 diabetic patients who were already diagnosed with diabetes for at least one year and 40 non-diabetic patients who had no history of elevated blood sugar levels.
Settings and conduct
This study included patients with type 2 diabetes from outpatient and inpatient clinics in Khartoum, Sudan. The study was carried out in four healthcare facilities in Khartoum, Sudan: the Jaber Abuelez Diabetic Center and Sameer Primary Healthcare Center for diabetic patients, and the Tooty Primary Healthcare Center and Shambat Primary Healthcare Center for non-diabetic patients.
Participants/Inclusion and exclusion criteria
Type 2 diabetic patients who agree to participate in the study.
Intervention groups
The intervention group underwent an exercise training program, which was performed three times per week for one year. It included a 10–15-minute warm-up, relaxation movements for cooldown, and exercise training using weight machines. The program consisted of 10 exercises, with 2 sets of each exercise repeated 10 times.
Main outcome variables
HbA1c levels
Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230827059278N1
Registration date:2023-08-30, 1402/06/08
Registration timing:retrospective
Last update:2023-08-30, 1402/06/08
Update count:0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Nahid Elfaki
Name of organization / entity
Najran University
Country
Sudan
Phone
+249 12 298 9400
Email address
weliameen1980@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-04, 1400/10/14
Expected recruitment end date
2023-04-28, 1402/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Exercise Training on glycemic control and Lipid Profile among type 2 Diabetic Patients: A randomized controlled trial
Public title
Effect of Exercise Training on glycemic control and Lipid Profile among type 2 Diabetic Patients: A randomized controlled trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes type 2
Agreement
35-50 years old
Exclusion criteria:
Type 1 diabetes
co morbidities
Age
From 35 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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
International University of Africa, Sudan
Street address
Africa Street
City
Khartoum
Postal code
00249
Approval date
2022-01-04, 1400/10/14
Ethics committee reference number
IUA/FM/04/01/22-04
Health conditions studied
1
Description of health condition studied
The study was conducted among 80 patients who were allocated into two groups: 40 diabetic patients who were already diagnosed with diabetes for at least one year and 40 non-diabetic patients who had no history of elevated blood sugar levels.
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Glycemic Control
Timepoint
one year
Method of measurement
HbA1C
2
Description
Lipid profile
Timepoint
one year
Method of measurement
Lipid profile test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: It includes a 10–15-minute warm-up, relaxation movements for cooldown, and exercise training using weight machines. The program consisted of 10 exercises, with 2 sets of each exercise repeated 10 times.
Category
Lifestyle
2
Description
Control group: no change in their lifestyle and exercise
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Jaber Abuelez Diabetic Center
Full name of responsible person
Maha Ali
Street address
Khartoum North
City
Khartoum
Postal code
00249
Phone
+249 12 298 9400
Email
weliameen1980@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Sameer Primary Healthcare Center
Full name of responsible person
Maha Ali
Street address
Sahafa
City
Khartoum
Postal code
00249
Phone
+249 12 298 9400
Email
weliameen1980@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International University of Africa
Full name of responsible person
Maha Hamed
Street address
Khartoum
City
Khartoum
Postal code
00249
Phone
+249 12 298 9400
Email
weliameen1980@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
self
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
King Khalid University
Full name of responsible person
Maha Ali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
al-Mufatahah
City
Abha
Province
Aseer
Postal code
62521
Phone
+966 50 438 7613
Email
maali@kku.edu.sa
Person responsible for scientific inquiries
Contact
Name of organization / entity
King Khalid University
Full name of responsible person
Maha Ali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
al-Mufatahah
City
Abha
Province
Aseer
Postal code
62521
Phone
+966 50 438 7613
Email
weliameen1980@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Al-Baha University
Full name of responsible person
Waled AM Ahmed
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
8088
City
Al Aqiq
Province
Al-Baha
Postal code
966
Phone
0066566282822
Email
Wahmed@bu.edu.sa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
NA
When the data will become available and for how long
NA
To whom data/document is available
NA
Under which criteria data/document could be used
NA
From where data/document is obtainable
NA
What processes are involved for a request to access data/document