An interventional study of Structured Exercise Program and Non structured exercise program in Diabetic Peripheral Neuropathy, sponsored by Maharishi Markendeswar University (Deemed to be University). Recruiting at 1 site in India. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Maharishi Markendeswar University (Deemed to be University) · Not applicable, Interventional, and Treatment
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.
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.
Maharishi Markendeswar University (Deemed to be University) is the lead sponsor of 41 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
Patients are provided with a simple exercise routine that lacks a structured format.
Other: Non structured exercise program
30 minutes of structured exercise programs
Non structured exercises
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.
Time frame: 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.
Time frame: 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.
Time frame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
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.
Time frame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
Plan to share: No
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Maharishi Markendeswar University (Deemed to be University)