Effect of Structured Training Program in Diabetic Patients

NCT06262074 | Recruiting DMC

• 1 other identifier: IEC-2418
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• NPRS

  The measurement will be taken during the baseline assessment and again after the completion of treatment.

Study Arms (2)

Group-1 (Structured Exercise Program)

EXPERIMENTAL

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.

Other: Structured Exercise Program

Group-2 (Non-Structured Exercise Program)

OTHER

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

Other: Non structured exercise program

Interventions

Structured Exercise Program OTHER

30 minutes of structured exercise programs

Group-1 (Structured Exercise Program)

Non structured exercise program OTHER

Non structured exercises

Group-2 (Non-Structured Exercise Program)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Study Sites (1)

MMIPR

Ambāla, Haryana, 133207, India

RECRUITING

Study Officials

• Khushboo Kumari, BPT, (MPT)

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subhasish Chatterjee, PhD

CONTACT

8708660994; subhasishphysio@mmumullana.org

Khushboo Kumari, BPT (MPT)

CONTACT

08718089830; physio.khushboo11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 15, 2024
• Study Start: February 8, 2024
• Primary Completion: February 8, 2024
• Study Completion: March 31, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)