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

NCT ID: NCT06101368

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-31

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.

Detailed Description

The study design is a randomized controlled trial, and participants will be blinded to avoid interaction. A convenience sampling technique will be used, and the study will take place at Pakistan Railways Hospital and Quaid-E-Azam University. It will span two years after receiving approval. Inclusion criteria specify the type of patients eligible for the study, while exclusion criteria identify conditions that disqualify participants. Various data collection tools and tests will be used, including Neuropathy Total Symptom Scale (NTSS-6), Berg Balance Scale, HbA1c, nerve conduction studies, blood glucose level measurements, dynamometer, and questionnaires assessing quality of life.

The study procedure involves participant recruitment, randomization into treatment and control groups, baseline assessments, and a 12-week intervention for the treatment group. This includes both aerobic exercise (treadmill) and resistance training for the lower and upper extremities. Control group participants will continue their regular medication.

Conditions

Type II Diabetes Mellitus With Neurological Manifestations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Physical Activity (Combined Aerobic and Resistance Training)

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.

Group Type: EXPERIMENTAL

Phsical Activity

Intervention Type: BEHAVIORAL

Combined Aerobic and Resistance Training

Control Group

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

Group Type: OTHER

Medication

Intervention Type: DRUG

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

Interventions

Phsical Activity

Combined Aerobic and Resistance Training

Intervention Type: BEHAVIORAL

Medication

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Education Research Foundation (HERF)

OTHER

Sponsor Role: lead

Responsible Party

Dr Danish Raouf

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waqar A Awan, PhD

Role: PRINCIPAL_INVESTIGATOR

Health Education Research Foundation

Raheela Kanwal, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Waqar Ahmed Awan, PhD

Role: CONTACT

wawan01@hotmail.com

+923335348846

Other Identifiers

RHS/EC/02-06-2023-011

Identifier Type: -

Identifier Source: org_study_id