Effect of Physical Activity on Neurogenesis in Peripheral Diabetic Neuropathy Type-II Diabetes

NCT06101368 | Unknown DMC

• 1 other identifier: RHS/EC/02-06-2023-011
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 425 million people worldwide suffer from diabetes, making it a global epidemic. Diabetes consumes 12% of the global health budget, addressing the disease and its complications. In Pakistan, the estimated prevalence of diabetes stands at 9.8%, affecting both males and females. Diabetic peripheral neuropathy is a common complaint that significantly impacts patients' quality of life. Neuropathy is prevalent in 40-55% of diabetes cases, and its incidence rises with age. Additionally, exercise can promote neurogenesis and the release of beneficial factors like BDNF, contributing to improved cognitive function and mood. Aerobic exercises are recommended for managing type 2 diabetes, while resistance training can improve glycemic control and muscle health. Further research is needed to understand the effects of physical activity on neurogenesis in diabetic peripheral neuropathy patients and gender-specific influences on glucose metabolism. The study aims to enhance peripheral neurogenesis, glycemic control, and sensory functions, ultimately improving the overall quality of life for patients.

Conditions

Type II Diabetes Mellitus With Neurological Manifestations

Outcome Measures

Primary Outcomes (8)

• Brain Derived Neurotrophic Factor (BDNF)

  BDNF is a member of the trophic factors of nerve regeneration microenvironment and therefore involved in the regulation of nerve fiber regeneration and protection of neurons

  Baseline to after 12th Week

• Nerve Growth Factor (NGF)

  Nerve growth factor (NGF) is a neurotrophic protein essential for the growth, differentiation, and survival of sympathetic and sensory afferent neurons during development

  Baseline to after 12th Week

• Vascular Endothelial Growth Factor (VEGF)

  VEGF enhances nerve blood flow and oxygen supply by inducing angiogenesis, in response to nerve ischemia and hypoxia caused by Diabetic Periphral Neuropathy

  Baseline to after 12th Week

• HBA1c

  HbA1c levels are associated with increased severity of peripheral neuropathy in patients with diabetes mellitus.

  Baseline to after 12th Week

• Nerve Conduction Study (NCS)

  A nerve conduction study (NCS) can quantitatively detect peripheral nerve dysfunction, even in the pre-symptomatic stage of DPN onset.

  Baseline to after 12th Week

• Berg Balance scale (BBS)

  The Berg Balance Scale (BBS) is a widely used clinical assessment tool that measures an individual's static and dynamic balance abilities. It is not specific to diabetic neuropathy but can be used to assess balance in individuals with various neurological and musculoskeletal conditions, including diabetic neuropathy.

  Baseline, after 4th week, after 8th week and after 12th week

• Neuropathy Total Symptom Scale (NTSS-6)

  Neuropathy Total Symptom Score-6 Questionnaire (NTSS-6) is a valid instrument for assessing the positive symptoms of diabetic peripheral neuropathy (DPN). Graphic representation of pain.

  Baseline, after 4th week, after 8th week and after 12th week

• Dynamometry lower limb

  Dynamometry is a method used to measure muscle strength, and it can be particularly useful in assessing muscle strength in the lower limbs of individuals with diabetic neuropathy.

  Baseline, after 4th week, after 8th week and after 12th week

Study Arms (2)

Physical Activity (Combined Aerobic and Resistance Training)

EXPERIMENTAL

Group A will perform aerobic and resistance exercises at a moderate level. Brisk Walk on treadmill 5 days/week with 40-70% of Vo2max (maximal aerobic capacity) 150 min/week 50-55% humidity and a room temperature of 24-25 °C will maintain. The subject will wear insole proper fitted shoes. Aerobic exercise will be conducted for a total of 30 minutes per session for 5 days for 12 weeks. This protocol will be followed by a 10-minute warm-up and cool-down. Followed by 10-15 minutes of resistance-based exercises at a moderate intensity of three sets with 15 repetitions of upper and lower limbs respectively i.e. Dumbbell biceps curl, Standing dumbbell triceps extension, Dumbbell stiff-legged deadlifts and Dumbbell squats Resistance loads will be 40-50% of one repetition maximum. The resting interval between resistance training sets will be \< 1 min.

Behavioral: Phsical Activity

Control Group

OTHER

The control group will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication

Drug: Medication

Interventions

Phsical Activity BEHAVIORAL

Combined Aerobic and Resistance Training

Physical Activity (Combined Aerobic and Resistance Training)

Medication DRUG

The drug will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication

Control Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Type-II Peripheral Diabetic Neuropathy
• Neuropathy Total Symptom Scale (NTSS-6)\>6
• loss of protective sensation to detect a 10-gram Semmes Weinstein Monofilament on either foot at one of four sites tested or a vibration perception threshold value of 25V or more at either foot's hallux
• Numbness or reduced ability to feel pain or temperature changes.
• Able to Perform 20 minutes per week \>2 bouts of physical activity
• Tingling or burning sensation.
• Sharp pains or cramps.
• Increased sensitivity to touch
• Symptoms last ≥ 6 months
• HbA1c above 6.5% \<12%
• Berg Balance Scale score 45-56

You may not qualify if:

• Patients with walking difficulty
• Retinopathy \& poor vision
• Inability to engage in activity without assistance
• Peripheral vascular disease e.g. ABI \<0.6
• orthostatic hypotension, resting heart rate above 100 bpm any Cardiac Issues
• Any diagnosed neuro-psychological issue e.g. depression, dementia or anxiety
• Lower limb amputation,foot deformity or ulceration
• Acute injury
• Hip and Knee OA

Sponsors & Collaborators

• Health Education Research Foundation (HERF): lead

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Waqar A Awan, PhD

  Health Education Research Foundation

  PRINCIPAL INVESTIGATOR

• Raheela Kanwal, PhD

  College of Applied Medical Sciences, University of Hail, Hail, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waqar Ahmed Awan, PhD

CONTACT

+923335348846; wawan01@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10