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

Not Applicable

Completed

• Conditions: Peripheral Diabetic Neuropathy
• Interventions: Other: Moderate Physical Activity for Peripheral Diabetic Neuropathy

• Registration Number: NCT05491850
• Lead Sponsor: Riphah International University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-25
• Study First Submitted: 2022-07-31
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-04
• Last Update Submitted: 2022-08-04
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Physical Activity Group	Moderate Physical Activity for Peripheral Diabetic Neuropathy	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.

Primary Outcome Measures

Name	Time	Method
Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes	2 Months	Research Hypothesis

Trial Locations

Locations (1)

RHS Rehabilitation Center; 🇵🇰 Islamabad, Federal, Pakistan