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Dose Response of Eccentric Exercise on Glycemic Control in Type II Diabetes Mellitus

Primary Purpose

Type II Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Eccentric Exercises Dose
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type II Diabetes Mellitus focused on measuring Dose response, Eccentric exercise, Type II Diabetes Mellitus, Glycemic index

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cleared by a general practitioner to attend the training program Sedentary patients with controlled type 2 diabetes, according to the definition of the American Diabetes Association.

Participants were untrained and had not engaged in resistance or aerobic exercise within 6 months prior to beginning the study.

Age between 45-65 Years. BMI should be 18.5-34.9 kg/m2.

Exclusion Criteria:

Participants with GIT disturbance (Gastroparesis and non-alcoholic fatty liver disease) will be excluded from the study.

Participants with any kind of Musculo-skeletal injury will be excluded from the study.

Participants with Stage II hypertension according to AHA guidelines. Participants who use tobacco products within the previous 6 months. Participants who take any type of systematic medication within the previous 6 months except diabetes.

Participants with any symptoms of neuropathy, retinopathy or nephropathy will be excluded

Sites / Locations

  • Rehabilitation Department, PSRD Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks.

This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks.

This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks.

This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks.

Outcomes

Primary Outcome Measures

Glucometer
Glucometer will use to monitor glucose before and after the intervention. Glucometer have poor validity and reliability but consider medical tool for the management of diabetes.
HBA1c
The A1C test is the most common diagnostic and screening tool used for Type II Diabetes Mellitus (T2DM) management and research

Secondary Outcome Measures

WHO-QOL (BREF-Urdu version)
WHOQOL-BREF is a short version of WHOQOL-100 developed under the supervision of World Health Organization.
Six Minutes' Walk Test
The Six-minute walk test (6-MWT) is also a widely used method for evaluating cardiopulmonary performance
Dynamometer
Commonly used devices that measure strength of body and include isometric lower limb muscle strength include dynamometers
Borg's Exertion Scale
Borg scale of exertion is widely used in patients to identify intensity of exercise
BERG Balance Scale
This scale is commonly used to check risk fall in elderly population
Joint error position test
Joint position error (JPE) is widely used to quantitatively assess proprioception in rehabilitation and sport science

Full Information

First Posted
March 7, 2021
Last Updated
July 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04790526
Brief Title
Dose Response of Eccentric Exercise on Glycemic Control in Type II Diabetes Mellitus
Official Title
Dose Response of Eccentric Exercises on Glycemic Control in Type ii Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The major aim of this project to check the dose response of eccentric exercise in reduction of glycemic index in type II Diabetes Mellitus. This study aim to check the effect of eccentric exercises on Glycemic index, quality of life, strength, exertion, balance and proprioception in type II Diabetes Mellitus patients
Detailed Description
From the last three decades, the diabetes mellitus progress quadrupled.The International Diabetes Federation (IDF) approximate that 1 in 11 adults with age between 20 to 79 years have diabetes mellitus. Almost 90 percent of patients diagnosed with Diabetes Mellitus are type 2 diabetes mellitus patients. According to the World Health Organization, Diabetes mellitus could be 7th leading cause of death. Type II Diabetes Mellitus (T2DM) increase progressively that affect around 25 million people in Europe and major public health issue for middle income countries. It is proposed that the prevalence of diabetes mellitus will increase up to 67% in middle-income countries from 2010 to 2030. In Pakistan, the Type II Diabetes Mellitus prevalence in 2018 is 11.77%. The prevalence is more in male as compared to females and urban area have 14.81 percent as compared to rural area. The genetic architecture might partially determine an individual's response to environmental changes.The risk factors of Type II Diabetes Mellitus include obesity, ageing, behavioral and environment factors, diet and lifestyle. School-age children had also warned of a rise in childhood obesity in Pakistan, which is considered a strong risk factor in diabetic patients. The major cause of Type II Diabetes Mellitus is deficiency or loss of insulin. Brain utilize glucose as source of energy and when brain is unable to maintain integrity, Many physiological mechanism initiates to reduce and limit the effect of hypoglycemia.The response of human body in reaction to reduce glucose level causes lowering the secretion of insulin and release counter-regulatory hormone.Diabetes mellitus have strong correlation for reduction in muscular strength and functional status. A recent study on global burden of diseases, Diabetes mellitus considered as ninth major cause of reduced life expectancy. A study conducted decades ago concluded that 3.96 million deaths occur due to diabetes mellitus with aged between 20-79 years. According to the International Diabetes Federation, the number and complications of diabetes mellitus increase rapidly up to 5.0 million deaths due to metabolic disorder.The prevalence of disability occurrence due to diabetes mellitus increase significantly since 3 decades ago. According to the global burden of Disease, Injuries and Risk factor statement, the 10th most common factor of disability was fasting level of glucose in 1990, 4th common cause till 2005 and 3rd common cause in 2015.45.8 percent of diabetes mellitus patients were approximately not diagnosed. Those patient who are not diagnosed have more risk of complication as compared to those who are diagnosed and start intervention. Medical expenditure of diabetes mellitus patients increases three times more than general population.The cases of people living suffering from Type II Diabetes Mellitus increase quadrupled between 1980 and 2014 globally. Adults who have diagnosed diabetes mellitus enhance to 20 percent from 2010 to 2030 and predicted to increase rapidly up to 69 percent. In Asia, the epidemic of Type II Diabetes Mellitus progress very rapidly and characterized by onset at a lower BMI and younger age than in Western populations. An average cost for the treatment of Diabetes Mellitus in Pakistan ranges from 650 to 20000 PKR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
Dose response, Eccentric exercise, Type II Diabetes Mellitus, Glycemic index

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks.
Arm Title
Group B
Arm Type
Experimental
Arm Description
This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks.
Arm Title
Group C
Arm Type
Experimental
Arm Description
This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks.
Arm Title
Group D
Arm Type
Experimental
Arm Description
This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks.
Intervention Type
Other
Intervention Name(s)
Eccentric Exercises Dose
Intervention Description
Eccentric exercise will be done treadmill in control environment. The treadmill will be declined to 16 degree and 3 sessions of 10 minutes duration will be given wit 1 minute of rest in each session. 10 minutes of warm up and cool down session will be given that includes stretching and stationary bicycle with out any resistance
Primary Outcome Measure Information:
Title
Glucometer
Description
Glucometer will use to monitor glucose before and after the intervention. Glucometer have poor validity and reliability but consider medical tool for the management of diabetes.
Time Frame
12 week
Title
HBA1c
Description
The A1C test is the most common diagnostic and screening tool used for Type II Diabetes Mellitus (T2DM) management and research
Time Frame
0 week and 12th week
Secondary Outcome Measure Information:
Title
WHO-QOL (BREF-Urdu version)
Description
WHOQOL-BREF is a short version of WHOQOL-100 developed under the supervision of World Health Organization.
Time Frame
0 week,4th week,8th week and 12th week
Title
Six Minutes' Walk Test
Description
The Six-minute walk test (6-MWT) is also a widely used method for evaluating cardiopulmonary performance
Time Frame
0 week,4th week,8th week and 12th week
Title
Dynamometer
Description
Commonly used devices that measure strength of body and include isometric lower limb muscle strength include dynamometers
Time Frame
0 week,4th week,8th week and 12th week
Title
Borg's Exertion Scale
Description
Borg scale of exertion is widely used in patients to identify intensity of exercise
Time Frame
0 week,4th week,8th week and 12th week
Title
BERG Balance Scale
Description
This scale is commonly used to check risk fall in elderly population
Time Frame
0 week,4th week,8th week and 12th week
Title
Joint error position test
Description
Joint position error (JPE) is widely used to quantitatively assess proprioception in rehabilitation and sport science
Time Frame
0 week,4th week,8th week and 12th week

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patient with Type II Diabetes Mellitus
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cleared by a general practitioner to attend the training program Sedentary patients with controlled type 2 diabetes, according to the definition of the American Diabetes Association. Participants were untrained and had not engaged in resistance or aerobic exercise within 6 months prior to beginning the study. Age between 45-65 Years. BMI should be 18.5-34.9 kg/m2. Exclusion Criteria: Participants with GIT disturbance (Gastroparesis and non-alcoholic fatty liver disease) will be excluded from the study. Participants with any kind of Musculo-skeletal injury will be excluded from the study. Participants with Stage II hypertension according to AHA guidelines. Participants who use tobacco products within the previous 6 months. Participants who take any type of systematic medication within the previous 6 months except diabetes. Participants with any symptoms of neuropathy, retinopathy or nephropathy will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Faheem Afzal, *PhD
Organizational Affiliation
Lahore Medical and Dental College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Department, PSRD Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Dose Response of Eccentric Exercise on Glycemic Control in Type II Diabetes Mellitus

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