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)
17
1
2
2.8
6.1

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
  • 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.

Outcome Measures

Primary Outcome Measures

  1. 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:
No
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:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Waqar Ahmed Awan, Principal Investigator, Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022