Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN.

NCT ID: NCT06130917

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2024-04-10

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.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

Experimental group will receive education on diabetes and conventional treatment exercises. The interventional multisystem exercises program will consist of four components, with each exercise lasting for a duration of 10 minutes per session. These components encompass proprioception training, balance exercises, strengthening routines, and reaction time training. This total multisystem exercises session will be performed for 30 minute, 3 times a week for 8 weeks in total.

Group Type: EXPERIMENTAL

Multisystem Exercise

Intervention Type: OTHER

Proprioception: Seated ankle ball. Single leg stance with support and with extension of knees. Single leg stance (hip extension) with support and with extension' of knees.

Muscle strengthening: Seated alternate double knee lifts with weights, chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights.

Balance Training Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support.. Crossover with support Reaction time Seated alternate touches to front. Seated alternate touches to back. Seated alternate touches to side. Seated alternate touches to 3 steps (forward, side, backward).

Control group

Control group will receive health education on diabetes. Conventional treatment will include Stretching, Range of motion (ROM) exercise , balance and strengthening for 10 minutes each exercise in one session. Each stretch holds for 15-20 sec. This exercise session will be performed for 30 minute, 3 times a week for 8 weeks in total.

Group Type: OTHER

Conventional Treatment

Intervention Type: OTHER

ROM exercises Passive ROM exercise of hip. Passive ROM exercise of knee. Passive ROM exercise of ankle Muscle strengthening Seated alternate double knee lifts with weights. chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights.

Balance Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support. Crossover with support Stretching exercises Stretching exercise of hamstring. Stretching exercise of quadriceps. Stretching exercise of calf muscle

Interventions

Multisystem Exercise

Proprioception: Seated ankle ball. Single leg stance with support and with extension of knees. Single leg stance (hip extension) with support and with extension' of knees.

Muscle strengthening: Seated alternate double knee lifts with weights, chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights.

Balance Training Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support.. Crossover with support Reaction time Seated alternate touches to front. Seated alternate touches to back. Seated alternate touches to side. Seated alternate touches to 3 steps (forward, side, backward).

Intervention Type: OTHER

Conventional Treatment

ROM exercises Passive ROM exercise of hip. Passive ROM exercise of knee. Passive ROM exercise of ankle Muscle strengthening Seated alternate double knee lifts with weights. chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights.

Balance Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support. Crossover with support Stretching exercises Stretching exercise of hamstring. Stretching exercise of quadriceps. Stretching exercise of calf muscle

Intervention Type: OTHER

Other Intervention Names

Experimental Group; Control Group

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University Pakistan

Locations

DHQ Pakpattan

Pakpattan, Punjab Province, Pakistan

Countries

Pakistan

References

Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6.

Reference Type: DERIVED

PMID: 40016658 (View on PubMed)

Other Identifiers

REC/0242 Sidra khurshid

Identifier Type: -

Identifier Source: org_study_id