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

NCT ID: NCT05491850

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2021-12-25

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.

Conditions

Peripheral Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Physical Activity Group

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.

Group Type: EXPERIMENTAL

Moderate Physical Activity for Peripheral Diabetic Neuropathy

Intervention Type: OTHER

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.

Non Specific Physical Activity Group

The Control group continues their regular medication for diabetic neuropathy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Moderate Physical Activity for Peripheral Diabetic Neuropathy

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Waqar Ahmed Awan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RHS Rehabilitation Center

Islamabad, Federal, Pakistan

Countries

Pakistan

Other Identifiers

RIPHAH/FR&AHS/Letter-0985

Identifier Type: -

Identifier Source: org_study_id