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

NCT05491850 | Completed DMC

• 1 other identifier: RIPHAH/FR&AHS/Letter-0985
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy

Outcome Measures

Primary Outcomes (1)

• Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes

  Research Hypothesis

  2 Months

Study Arms (2)

Moderate Physical Activity Group

EXPERIMENTAL

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

Non Specific Physical Activity Group

NO INTERVENTION

The Control group continues their regular medication for diabetic neuropathy.

Interventions

Moderate Physical Activity for Peripheral Diabetic Neuropathy 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.

Moderate Physical Activity Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Cardiac Issues
• Any neurological issue
• Lower limb deformity
• Acute injury
• Hip and Knee OA
• Patients with walking difficulty
• Diabetic foot

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

RHS Rehabilitation Center

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 8, 2022
• Study Start: October 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 25, 2021
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)