An interventional study of Phsical Activity and Medication in Type II Diabetes Mellitus With Neurological Manifestations, sponsored by Health Education Research Foundation (HERF). Not yet recruiting. Open to participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Health Education Research Foundation (HERF) · Not applicable, Interventional, and Prevention
Approximately 425 million people worldwide suffer from diabetes, making it a global epidemic. Diabetes consumes 12% of the global health budget, addressing the disease and its complications. In Pakistan, the estimated prevalence of diabetes stands at 9.8%, affecting both males and females. Diabetic peripheral neuropathy is a common complaint that significantly impacts patients' quality of life. Neuropathy is prevalent in 40-55% of diabetes cases, and its incidence rises with age. Additionally, exercise can promote neurogenesis and the release of beneficial factors like BDNF, contributing to improved cognitive function and mood. Aerobic exercises are recommended for managing type 2 diabetes, while resistance training can improve glycemic control and muscle health. Further research is needed to understand the effects of physical activity on neurogenesis in diabetic peripheral neuropathy patients and gender-specific influences on glucose metabolism. The study aims to enhance peripheral neurogenesis, glycemic control, and sensory functions, ultimately improving the overall quality of life for patients.
The study design is a randomized controlled trial, and participants will be blinded to avoid interaction. A convenience sampling technique will be used, and the study will take place at Pakistan Railways Hospital and Quaid-E-Azam University. It will span two years after receiving approval. Inclusion criteria specify the type of patients eligible for the study, while exclusion criteria identify conditions that disqualify participants. Various data collection tools and tests will be used, including Neuropathy Total Symptom Scale (NTSS-6), Berg Balance Scale, HbA1c, nerve conduction studies, blood glucose level measurements, dynamometer, and questionnaires assessing quality of life.
The study procedure involves participant recruitment, randomization into treatment and control groups, baseline assessments, and a 12-week intervention for the treatment group. This includes both aerobic exercise (treadmill) and resistance training for the lower and upper extremities. Control group participants will continue their regular medication.
617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.
This study's planned enrollment of 44 is below the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.
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Exclusion Criteria:
Group A will perform aerobic and resistance exercises at a moderate level. Brisk Walk on treadmill 5 days/week with 40-70% of Vo2max (maximal aerobic capacity) 150 min/week 50-55% humidity and a room temperature of 24-25 °C will maintain. The subject will wear insole proper fitted shoes. Aerobic exercise will be conducted for a total of 30 minutes per session for 5 days for 12 weeks. This protocol will be followed by a 10-minute warm-up and cool-down. Followed by 10-15 minutes of resistance-based exercises at a moderate intensity of three sets with 15 repetitions of upper and lower limbs respectively i.e. Dumbbell biceps curl, Standing dumbbell triceps extension, Dumbbell stiff-legged deadlifts and Dumbbell squats Resistance loads will be 40-50% of one repetition maximum. The resting interval between resistance training sets will be \< 1 min.
Behavioral: Phsical Activity
The control group will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication
Drug: Medication
Combined Aerobic and Resistance Training
The drug will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication
Brain Derived Neurotrophic Factor (BDNF)
BDNF is a member of the trophic factors of nerve regeneration microenvironment and therefore involved in the regulation of nerve fiber regeneration and protection of neurons
Time frame: Baseline to after 12th Week
Nerve Growth Factor (NGF)
Nerve growth factor (NGF) is a neurotrophic protein essential for the growth, differentiation, and survival of sympathetic and sensory afferent neurons during development
Time frame: Baseline to after 12th Week
Vascular Endothelial Growth Factor (VEGF)
VEGF enhances nerve blood flow and oxygen supply by inducing angiogenesis, in response to nerve ischemia and hypoxia caused by Diabetic Periphral Neuropathy
Time frame: Baseline to after 12th Week
HBA1c
HbA1c levels are associated with increased severity of peripheral neuropathy in patients with diabetes mellitus.
Time frame: Baseline to after 12th Week
Nerve Conduction Study (NCS)
A nerve conduction study (NCS) can quantitatively detect peripheral nerve dysfunction, even in the pre-symptomatic stage of DPN onset.
Time frame: Baseline to after 12th Week
Berg Balance scale (BBS)
The Berg Balance Scale (BBS) is a widely used clinical assessment tool that measures an individual's static and dynamic balance abilities. It is not specific to diabetic neuropathy but can be used to assess balance in individuals with various neurological and musculoskeletal conditions, including diabetic neuropathy.
Time frame: Baseline, after 4th week, after 8th week and after 12th week
Neuropathy Total Symptom Scale (NTSS-6)
Neuropathy Total Symptom Score-6 Questionnaire (NTSS-6) is a valid instrument for assessing the positive symptoms of diabetic peripheral neuropathy (DPN). Graphic representation of pain.
Time frame: Baseline, after 4th week, after 8th week and after 12th week
Dynamometry lower limb
Dynamometry is a method used to measure muscle strength, and it can be particularly useful in assessing muscle strength in the lower limbs of individuals with diabetic neuropathy.
Time frame: Baseline, after 4th week, after 8th week and after 12th week
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Health Education Research Foundation (HERF)