Effect of Structured Training Program in Diabetic Patients

NCT ID: NCT06262074

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group-1 (Structured Exercise Program)

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.

Group Type EXPERIMENTAL

Structured Exercise Program

Intervention Type OTHER

30 minutes of structured exercise programs

Group-2 (Non-Structured Exercise Program)

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

Group Type OTHER

Non structured exercise program

Intervention Type OTHER

Non structured exercises

Interventions

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Structured Exercise Program

30 minutes of structured exercise programs

Intervention Type OTHER

Non structured exercise program

Non structured exercises

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role lead

Responsible Party

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Subhasish Chatterjee

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khushboo Kumari, BPT, (MPT)

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar Instirtute of Physiotherapy and Rehabilitation, Ambala, Haryana, 133207

Locations

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MMIPR

Ambāla, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Subhasish Chatterjee, PhD

Role: CONTACT

8708660994

Khushboo Kumari, BPT (MPT)

Role: CONTACT

08718089830

Facility Contacts

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Subhashish Chatterjee, MPT(NEURO)

Role: primary

+918950037407

Other Identifiers

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IEC-2418

Identifier Type: -

Identifier Source: org_study_id

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