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Clinical Trials/NCT05491850
NCT05491850CompletedNot Applicable

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

Riphah International University1 site in 1 country17 target enrollmentStarted: October 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

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.

Intervention: Moderate Physical Activity for Peripheral Diabetic Neuropathy (Other)

Non Specific Physical Activity Group

No Intervention

The Control group continues their regular medication for diabetic neuropathy.

Outcomes

Primary Outcomes

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

Time Frame: 2 Months

Research Hypothesis

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Waqar Ahmed Awan

Principal Investigator

Riphah International University

Study Sites (1)

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