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

Primary Purpose

Peripheral Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Moderate Physical Activity for Peripheral Diabetic Neuropathy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Diabetic Neuropathy focused on measuring Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • RHS Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Moderate Physical Activity Group

Non Specific Physical Activity Group

Arm Description

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.

The Control group continues their regular medication for diabetic neuropathy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2022
Last Updated
August 4, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05491850
Brief Title
Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial
Official Title
Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Diabetic Neuropathy
Keywords
Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Physical Activity Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non Specific Physical Activity Group
Arm Type
No Intervention
Arm Description
The Control group continues their regular medication for diabetic neuropathy.
Intervention Type
Other
Intervention Name(s)
Moderate Physical Activity for Peripheral Diabetic Neuropathy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes
Description
Research Hypothesis
Time Frame
2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
RHS Rehabilitation Center
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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