Clinical trial NCT06130917: Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN.
Official title: Effects of Multisystem Exercise Program on Balance, Postural Stability, Mobility and Pain in Patients With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Balance, Multisystem Exercise, Peripheral neuropathy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Upto the best knowledge of researcher, multisystem exercise program has been utilized in various populations, encompassing both healthy individuals and patients with diverse medical conditions. However, its specific impact on the diabetic peripheral neuropathy population, particularly in terms of improving balance, postural stability and mobility remains inadequately explored.

Detailed description: Diabetic peripheral neuropathy is a common and highly prevalent complication of type 2 diabetes mellitus, posing a significant global health concern. It affects a considerable number of individuals with diabetes, leading to progressive nerve damage and functional impairments. The multifaceted nature of this condition manifests in various ways, including sensory, motor, and autonomic dysfunction. Its insidious onset and gradual progression impose a substantial burden on patients, reducing their quality of life and presenting significant challenges for healthcare providers. Therefore, understanding the underlying causes, mechanisms, and management strategies of diabetic peripheral neuropathy is essential to alleviate its impact and enhance the overall well-being of those affected by this condition. Patients with diabetic peripheral neuropathy encounter a range of distressing symptoms that profoundly influence their daily activities. Sensory manifestations, such as numbness, tingling, and pain, are common, especially among older individuals with diabetes. Challenges in detecting temperature and touch also increase the risk of burns or injuries. Motor neuropathy results in muscle weakness, loss of balance, and coordination difficulties, making simple tasks like walking or holding objects more challenging. Furthermore, diabetic peripheral neuropathy plays a significant role in falls among elderly patients due to balance disorders and proprioception impairment. To address these issues and improve patients' quality of life, exercise has emerged as a valuable therapeutic intervention. Regular exercise programs, specifically those incorporating balance training exercises, have shown promising outcomes in enhancing balance and reducing falls among those with diabetic peripheral neuropathy. By emphasizing a comprehensive approach to exercise, targeting proprioception, coordination, and lower limb strength, patients can benefit from improved sensory integration, enhanced muscle control, and postural stability, ultimately promoting greater independence and reducing the risk of falls. Through a well-designed randomized controlled trial, exploring the effectiveness of a multisystem exercise program, further advancements in managing diabetic peripheral neuropathy can be achieved, leading to improved patient outcomes and enhanced quality of life.

Eligibility criteria: Inclusion Criteria:

* Both genders (male, female)
* Age (40-60)
* Patients who are screened for diabetic peripheral neuropathy
* Moderate balance impairment on Berg Balance Scale (21-40)
* Patients who met the criteria of Diabetic Neuropathy 4 scored equal or greater than 4.
* Patients who have positive sharpened Romberg test

Exclusion Criteria:

* Patients with any recent surgery of lower limb
* Patients with crutches
* Patients with gangrene
* Patients with lower BMI
* patients with Deep Venous Thrombosis (DVT)
* patients with amputations
* Patients with neurological impairments in the central nervous system and vestibular system
* Patients with orthostatic hypotension

Primary outcomes:
measure: Beg Balance Scale
timeFrame: 8 weeks
measure: Functional reach test
timeFrame: 8 weeks
measure: Timed Up and Go test
timeFrame: 8 weeks
measure: Ten meter walk test
timeFrame: 8 weeks
measure: Numeric pain rating scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pakpattan
country: Pakistan
facility: DHQ Pakpattan
state: Punjab
Study officials:
affiliation: Riphah International University Pakistan
name: Aruba Saeed, PhD*
role: PRINCIPAL_INVESTIGATOR
References: