Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial

Study Overview
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Brief Summary
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This study determines the effects of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes. Most of the literature shows the impact of physical activity to manage/controlling diabetes. Some studies were conducted on animals to study the impact of physical activity on diabetic neuropathy and neurogenesis. There is no study on the impact of physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans. This study finds the impact of moderate physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans.

Official Title
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Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial

Conditions
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Peripheral Diabetic Neuropathy

Intervention / Treatment
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* Other: Moderate Physical Activity for Peripheral Diabetic Neuropathy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type-II Diabetes Diagnosed cases of Peripheral Diabetic Neuropathy Peripheral Diabetic Neuropathy Stage 1 & 2 Numbness or reduced ability to feel pain or temperature changes. Tingling or burning sensation. Sharp pains or cramps. Increased sensitivity to touch Males and females Age: 35-65 HbA1c above 6.5 Mild activity level on IPAQ-7 (< 150min/per week) Berg Balance Scale score (< 45) Exclusion Criteria: Cardiac Issues Any neurological issue Lower limb deformity Acute injury Hip and Knee OA Patients with walking difficulty Diabetic foot

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Physical Activity Group<br>The Experimental Group gets moderate physical activity. Elliptical will be performed at least 5 days/per week. Moderate intensity, corresponding approximately to 40-60% of Vo2max (maximal aerobic capacity) 150 min/week of exercise undertaken at moderate intensity or greater. Warm-up and Dynamic stretching is given before and static stretching is given after moderate physical activity. | Other: Moderate Physical Activity for Peripheral Diabetic Neuropathy<br>* Moderate physical activity can increase movement and heart rate are particularly important for people suffering with peripheral neuropathy. Physical activity can improve blood circulation, which strengthens nerve tissues by increasing the flow of oxygen.<br>|
| No Intervention: Non Specific Physical Activity Group<br>The Control group continues their regular medication for diabetic neuropathy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes | Research Hypothesis | 2 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy