Dose Response of Eccentric Exercise on Glycemic Control in Type II Diabetes Mellitus
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| ClinicalTrials.gov Identifier: NCT04790526 |
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Recruitment Status :
Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type II Diabetes Mellitus | Other: Eccentric Exercises Dose | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Prevention |
| Official Title: | Dose Response of Eccentric Exercises on Glycemic Control in Type ii Diabetes Mellitus |
| Actual Study Start Date : | March 1, 2021 |
| Estimated Primary Completion Date : | March 30, 2022 |
| Estimated Study Completion Date : | April 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group A
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.
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Other: Eccentric Exercises Dose
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 |
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Experimental: Group B
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.
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Other: Eccentric Exercises Dose
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 |
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Experimental: Group C
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.
|
Other: Eccentric Exercises Dose
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 |
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Experimental: Group D
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.
|
Other: Eccentric Exercises Dose
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 |
- Glucometer [ Time Frame: 12 week ]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 [ Time Frame: 0 week and 12th week ]The A1C test is the most common diagnostic and screening tool used for Type II Diabetes Mellitus (T2DM) management and research
- WHO-QOL (BREF-Urdu version) [ Time Frame: 0 week,4th week,8th week and 12th week ]WHOQOL-BREF is a short version of WHOQOL-100 developed under the supervision of World Health Organization.
- Six Minutes' Walk Test [ Time Frame: 0 week,4th week,8th week and 12th week ]The Six-minute walk test (6-MWT) is also a widely used method for evaluating cardiopulmonary performance
- Dynamometer [ Time Frame: 0 week,4th week,8th week and 12th week ]Commonly used devices that measure strength of body and include isometric lower limb muscle strength include dynamometers
- Borg's Exertion Scale [ Time Frame: 0 week,4th week,8th week and 12th week ]Borg scale of exertion is widely used in patients to identify intensity of exercise
- BERG Balance Scale [ Time Frame: 0 week,4th week,8th week and 12th week ]This scale is commonly used to check risk fall in elderly population
- Joint error position test [ Time Frame: 0 week,4th week,8th week and 12th week ]Joint position error (JPE) is widely used to quantitatively assess proprioception in rehabilitation and sport science
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| Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Patient with Type II Diabetes Mellitus |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790526
| Contact: Waqar Ahmed, PhD | 03335348846 | waqar.ahmed@riphah.edu.pk |
| Pakistan | |
| Ghurki Trust Teaching Hospital | Recruiting |
| Lahore, Punjab, Pakistan, 44000 | |
| Contact: M Faheem Afzal, *PhD | |
| Principal Investigator: | M Faheem Afzal, *PhD | Lahore Medical and Dental College |
| Responsible Party: | Riphah International University |
| ClinicalTrials.gov Identifier: | NCT04790526 |
| Other Study ID Numbers: |
RiphahIU M Faheem Afzal |
| First Posted: | March 10, 2021 Key Record Dates |
| Last Update Posted: | March 10, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Dose response Eccentric exercise Type II Diabetes Mellitus Glycemic index |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |