Effect of Structured Training Program in Diabetic Patients

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Effect of Structured Training Program on Functional Abilities in Patients With Diabetic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262074
• Other study ID #: IEC-2418
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: Subhasish Chatterjee, PhD
• Phone: 8708660994
• Email: subhasishphysio[@]mmumullana.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Structured Exercise Program
30 minutes of structured exercise programs
• Non structured exercise program
Non structured exercises

Locations

Country	Name	City	State
India	MMIPR	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Michigan neuropathy screening instrument (MNSI)	The scale consists of two parts: the first part involves a patient history assessment, while the second part focuses on physical examination. This scale is considered both reliable and practical for evaluating the severity of neuropathy. If the patient's score increases, it indicates a higher severity of the disease, whereas if the score decreases, it suggests a lower severity.	The measurement will be taken during the baseline assessment and again after the completion of treatment.
Primary	Biothesiometer	This objective measure is utilized to assess the vibratory pressure threshold in affected areas. It possesses the capability to detect various frequencies for vibratory pressure threshold assessment. It is regarded as a practical tool for evaluating both superficial and vibratory sensations. If there is an increased perception of frequency, it indicates that the vibratory pressure threshold is more severely affected.	The measurement will be taken during the baseline assessment and again after the completion of treatment.
Primary	NeuroQoL	The Neuropathy-and Foot-Ulcer Specific Quality of Life Instrument is designed as a Likert scale and serves as a reliable method for assessing quality of life related to neuropathy. If the scoring indicates a higher value, it suggests that the disease is more severe.	The measurement will be taken during the baseline assessment and again after the completion of treatment.
Secondary	NPRS	The Numeric Pain Rating Scale, ranging from 0 to 10, is employed as a subjective assessment tool to measure an individual's pain perception. In general, higher scores on the scale indicate a greater severity of pain linked to the disease.	The measurement will be taken during the baseline assessment and again after the completion of treatment.