BRACE(Balance, Resistance, Aerobic and Cognitive Exercise) Protocol for Diabetic).Peripheral Neuropathic Patients.

NCT ID: NCT04832464

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2022-02-27

Brief Summary

The purpose of the study is to determine the effects of the BRACE( Balance, Resistance, Aerobic and Cognitive Exercise) protocol for balance training in patients with Diabetic Peripheral Neuropathy. A Randomized Control Trial is being conducted at Railways General Hospital, Rawalpindi. The sample size was calculated through the open epi tool. A total of 60 patients are divided into two groups, 30 participants in the experimental group and 30 participants in the control group. The study duration will be six months. The sampling technique applied was simple random sampling for recruitment and group randomization using the sealed envelope method. Patients with the age of 40-65 years having type II diabetes for more than 5 years are included in the study. Tools used in the study are Berg balance scale, timed up and go test, functional reach test, Montreal Cognitive Assessment scale (MOCA), and force plate. Data will be analyzed through Statistical Package for the Social Sciences (SPSS), version 21.

Detailed Description

American Diabetic Association (ADA) defined Diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with dysfunction of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels.

Most common among the neuropathies are chronic sensorimotor distal symmetric polyneuropathy (DPN) and autonomic neuropathies. According to ADA(American Diabetes Association), DPN(Diabetic Peripheral Neuropathy) is "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. It is estimated that 60% to 70% of individuals with diabetes have mild to severe forms of nervous system damage.

DPN(Diabetic Peripheral Neuropathy) causes decreased sensation, proprioception, reflexes, and strength in the lower extremities, leading to balance dysfunction. Physical therapy interventions utilized to reduce the balance dysfunction can range from restoration of the health of the neurons to sensory integration to compensatory strategies. Various treatment protocols include improving circulation, the guided practice of integrating internal and external sensory input, education on sensation loss and fall risk, instruction on home modifications, and introduction of assistive devices to minimize balance dysfunction.

A systematic and evidence-based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines.

Search term for the initial literature review was Diabetes mellitus, the prevalence of DPN(diabetic peripheral neuropathy), causes of peripheral neuropathies and loss of balance, the pathophysiology of diabetes-related peripheral neuropathy, treatment options for balance training, strengthening lower extremities, aerobics, cognitive approach. The search was limited to papers in English preferably published since 2000 with full text available. Different studies were available regarding balance exercises and their effects but limited data was available regarding BRACE ( Balance, Resistance, Anaerobic, and Cognitive Exercise) protocol as a whole in recent years.

Balance exercises are feasible and safe and have the potential to improve balance and gait. These should be used as supportive therapy for DPN patients. Lower extremity resistance (strengthening) exercises are fairly recommended for clinical use in treating balance dysfunction in patients with DPN than monochromatic infrared energy therapy, vibrating insoles, and use of a cane.

Previously, walking and weight-bearing were considered contraindicated in DPN patients to avoid foot ulcers, deformity, or fall risk. Emerging research has revealed positive adaptations in response to overload stress in these people, including evidence for peripheral neuroplasticity in animal models and early clinical trials.

According to WHO estimation, a number of individuals approximately 47 million worldwide have cognitive impairments which will increase to 75 million by 2030. A 2 years longitudinal study in Korea showed a significant association between cognitive decline and physical activity. Pain interference may be reduced following an aerobic exercise intervention among people with painful DPN, without a change in pain intensity.

Although, multiples researches have shown the effects of particular interventions on DPN still there is a lack of multi-component interventional studies to show the effects on balance issues.

Conditions

Diabetic Peripheral Neuropathy (DPN)

Study Design

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

Study Groups

Balance Training Home plan

The Control group is undergoing balance training only, 3 days a week, and will be for 8 weeks. Balance training includes 10minutes of warm-up and 30 minutes of balance exercises. A force plate will be used to measure the postural sways. Measurements will be taken at a base-line, after the first session, at mid-level (4th week) and at the end (8th week).

These exercises include Static Balance exercises(1-2weeks): Romberg with eyes open & close, Tandem standing with eyes open & close with alternate feet, Single leg stance.

Static/ Dynamic/ Anticipatory Postural Control (3-4weeks): Sit to Stand, FRT( forward reach test) that is forward, sideways, cross reach, and timed up and go test.

Static/ Dynamic/ Anticipatory? Reactive Postural Control (5-6weeks): Perturbations:

Controlled by the therapist in sitting & standing, Throwing a ball, kicking a ball.

(7-8weeks): Combination of All

Group Type: ACTIVE_COMPARATOR

RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.

Intervention Type: OTHER

therapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training.

BRACE Protocol: Balance training along with resistance, aerobic and cognitive excercises

BRACE protocol for balance training 3 days a week for 8 consecutive weeks on alternate days.

These exercises include Static Balance exercises(1-2weeks) plus Chair rise 30 sec without using hands, 6-minute walk, count reverse from 50, push the wall, and reverse count from 20.

Static, dynamic, anticipatory postural control (3-4weeks) plus Stair climbing without using rails, marching in space, remember 5 words, name 5 animals, repeat 5 words, spell the word like APPLE, spell backward again.

Static, dynamic, anticipatory postural control (5-6weeks) plus Squatting, cycling, count even numbers from 1-50.

calculation: Addition, subtraction, multiplication, division. (7-8weeks): Combination of all.

Group Type: EXPERIMENTAL

RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.

Intervention Type: OTHER

therapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training.

Interventions

RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.

therapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training.

Intervention Type: OTHER

Other Intervention Names

Balance Training Home plan

Eligibility Criteria

Inclusion Criteria

• Patients with type-2 Diabetes
• Diabetes of more than 5 years of the duration

Exclusion Criteria

• Patients have vertebrobasilar insufficiency (tested by VBI tests)
• Atlanto-axial instability (tested by sharp purser test)
• Osteoporosis
• Rheumatoid arthritis
• Neuropathies
• Recent surgeries

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imran Amjad, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Islamabad, Fedral, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

(+92)3324390125

Facility Contacts

Imran Amjad, PhD

Role: primary

imran.amjad@riphah.edu.pk

References

Pandey S, Raj IJS. Comparison of Game Based Rehabilitation and Mixed Sport Training on Balance in Diabetic Neuropathy: Lovely Professional University; 2017

Reference Type: BACKGROUND

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S67-74. doi: 10.2337/dc13-S067. No abstract available.

Reference Type: BACKGROUND

PMID: 23264425 (View on PubMed)

O'Sullivan SB, Schmitz TJ, Fulk G. Physical rehabilitation: FA Davis; 2019

Reference Type: BACKGROUND

Kluding PM, Bareiss SK, Hastings M, Marcus RL, Sinacore DR, Mueller MJ. Physical Training and Activity in People With Diabetic Peripheral Neuropathy: Paradigm Shift. Phys Ther. 2017 Jan 1;97(1):31-43. doi: 10.2522/ptj.20160124.

Reference Type: BACKGROUND

PMID: 27445060 (View on PubMed)

Ahmad I, Hussain E, Singla D, Verma S, Ali K. Balance Training in Diabetic Peripheral Neuropathy: A Narrative Review. JSM Diabetol Manag. 2017;2(1):1-9

Reference Type: BACKGROUND

Wallin A, Kettunen P, Johansson PM, Jonsdottir IH, Nilsson C, Nilsson M, Eckerstrom M, Nordlund A, Nyberg L, Sunnerhagen KS, Svensson J, Terzis B, Wahlund LO, Georg Kuhn H. Cognitive medicine - a new approach in health care science. BMC Psychiatry. 2018 Feb 8;18(1):42. doi: 10.1186/s12888-018-1615-0.

Reference Type: BACKGROUND

PMID: 29422020 (View on PubMed)

Kiani N, Marryam M, Malik AN, Amjad I. The effect of aerobic exercises on balance in diabetic neuropathy patients. Journal Of Medical Sciences. 2018;26(2):141-5

Reference Type: BACKGROUND

Other Identifiers

REC/00548 Azka Tariq

Identifier Type: -

Identifier Source: org_study_id