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

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT05491850

Collaborator

(none)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Diabetic Neuropathy	Other: Moderate Physical Activity for Peripheral Diabetic Neuropathy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Dec 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
No Intervention: Non Specific Physical Activity Group The Control group continues their regular medication for diabetic neuropathy.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

No Intervention: Non Specific Physical Activity Group

The Control group continues their regular medication for diabetic neuropathy.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RHS Rehabilitation Center	Islamabad	Federal	Pakistan	46000

Sponsors and Collaborators

Riphah International University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Waqar Ahmed Awan, Principal Investigator, Riphah International University

ClinicalTrials.gov Identifier:

NCT05491850

Other Study ID Numbers:

RIPHAH/FR&AHS/Letter-0985

First Posted:

Aug 8, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Waqar Ahmed Awan, Principal Investigator, Riphah International University

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

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Diabetic Neuropathies

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 8, 2022