Effect of Structured Training Program in Diabetic Patients

Maharishi Markendeswar University (Deemed to be University)

Status: Enrolling

Conditions: Diabetic Peripheral Neuropathy

Treatments: Other: Structured Exercise Program; Other: Non structured exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06262074

IEC-2418

Details and patient eligibility

About

Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.

Full description

The goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with DPN, despite the existence of various individualized exercise programs designed for DPN patients. The main questions this study aims to answer is:

What is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with DPN on pain, sensory symptoms, balance, vibration sense and Quality of life?

Group 1:

Patients in group 1 will receive a structured exercise program.

Group 2:

Patients in group 2 will receive a non-structured exercise program. This group will allow us to compare the effects of a structured and a non-structured exercise program.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diabetes mellitus with moderate to severe DPN
• Subjects of both gender
• Age from 40 to 70 years
• Independent walking
• MNSI score more than 2 out of 13

Exclusion criteria

• Presence of an active planter ulcer
• History of surgery during intervention period
• Neurological diseases other than DPN

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group-1 (Structured Exercise Program)

Experimental group

Description:

Patients undergo structured exercise sessions lasting 30 minutes, encompassing activities such as range of motion, flexibility exercises, strength training, balance exercises, and aerobic exercises, with designated intervals between each session.

Treatment:

Other: Structured Exercise Program

Group-2 (Non-Structured Exercise Program)

Other group

Description:

Patients are provided with a simple exercise routine that lacks a structured format.

Treatment:

Other: Non structured exercise program