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

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06130917
Collaborator
(none)
42
1
2
5.2
8.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multisystem Exercise
  • Other: Conventional Treatment
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants and outcome assessors will be kept blinded about the intervention which the patients will be going to receive.
Primary Purpose:
Treatment
Official Title:
Effects of Multisystem Exercise Program on Balance, Postural Stability, Mobility and Pain in Patients With Diabetic Peripheral Neuropathy
Anticipated Study Start Date :
Nov 5, 2023
Anticipated Primary Completion Date :
Apr 5, 2024
Anticipated Study Completion Date :
Apr 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Multisystem Exercise
Proprioception: Seated ankle ball. Single leg stance (hip flexion) with support and with flexion and extension of knees. Single leg stance (hip extension) with support and with flexion and extension of knees. Muscle strengthening: Seated alternate double knee lifts with weights. Modified 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).
Other Names:
  • Experimental Group
  • Other: Control group

    Control group will receive health education on diabetes. Conventional treatment will include Stretching, 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.

    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. Modified 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
    Other Names:
  • Control Group
  • Outcome Measures

    Primary Outcome Measures

    1. Beg Balance Scale [8 weeks]

      It is used to assess balance. , "Change will be measured from Baseline to 8 weeks"

    2. Functional reach test [8 weeks]

      It is a widely used clinical assessment tool to measure an individual's dynamic balance and stability. change will be measured from baseline to 8 weeks

    3. .Timed Up and Go Test [8 weeks]

      It is for the assessment of lower extremity function, mobility and fall risk. "Change will be measured from Baseline to 6 weeks"

    4. 10-m walk test: [8 weeks]

      It is a performance measure used to assess walking speed in meters per second over a short distance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Both genders (male, female)

    • Age (40-60)

    • Patients who are screened for diabetic peripheral neuropathy

    • Moderate balance impairment on BBS (21-40)

    • Patients who met the criteria of DN4 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 DVT

    • patients with amputations

    • Patients with neurological impairments in the central nervous system and vestibular system

    • Patients with orthostatic hypotension

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DHQ Pakpattan Pakpattan Punjab Pakistan 57400

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: Aruba Saeed, PhD*, Riphah International University Pakistan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT06130917
    Other Study ID Numbers:
    • REC/0242 Sidra khurshid
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2023