Strength And Balance Training on Diabetic Peripheral Neuropathy

NCT04807452 | Completed

• 1 other identifier: REC/00667 Farhan Haleem
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized Control Trial was conducted on 20 participants, equally allocated in strength plus balance and aerobic group from February-2020 until December-2020.Participants were selected according to inclusion and exclusion criteria on purposive sampling technique and randomization was done by sealed envelope method. Inclusion criteria was both gender, 40 years to 80 years, Patients with type 2 diabetes ,diabetic peripheral neuropathy and Toronto neuropathy score 6 or greater. Participants were assessed after taking consent before and after 12 sessions through Toronto clinically neuropathy system, SF-36 and berg balance scale. Data was analyzed using SPSS v.22.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Resistance Training; Diabetic Neuropathies; Quality of Life; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Toronto Clinical Neuropathy Scoring System

  This tool is used for assessing changes from baseline. This is a quantitative scoring system for evaluating the severity of peripheral neuropathy primarily for the feet. Total score ranges from normal=0 to maximum= 19. Interpretation: * No neuropathy 0-5 points * Mild neuropathy 6-8 points * Moderate neuropathy 9-11 points * Severe neuropathy 12+ points Toronto Clinical Neuropathy Scoring System has good inter-class reliability (Cronbach's alpha 0.86). It is a valid instrument to reflect the presence and severity of DSP as measured by sural nerve morphology and electrophysiology findings, and morphological changes in DSP. This evidence suggests that the Toronto CSS may prove useful in documenting and monitoring DSP in the clinic and in clinical research trials.

  4th week

Other Outcomes (2)

• Health Related Quality of Life Short Form 36 v2

  4th week

• Berg Balance Scale

  4th week

Study Arms (2)

Strength and balance training

ACTIVE COMPARATOR

Exercises like ROMS, stretching, static balance and dynamic balance

Other: Strength and balance training

Aerobics training

EXPERIMENTAL

Control Group received aerobic training.

Other: Aerobics training

Interventions

Strength and balance training OTHER

Passive ROM to possible level of knee (flexion and extension), ankle (dorsiflexion and plantar flexion), forefoot (inversion and eversion) and toe (flexion and extension, adduction and abduction) joints.Resisted flexion and extension of knee, dorsiflexion and planter flexion of ankle, inversion and eversion of foot, flexion/extension, and abduction/adduction of toe with help of thera-band.The exercise prescription for strength training was made at approximately 50% of the estimated 1-RM. Exercise progression was achieved by instructing participants to increase the weight lifted in a specific exercise when they could perform 2 sets of 10-12 repetitions without maximal exertion on 2 consecutive training days. On basis of Borg Rating of Perceived Exertion of 10 to 13.Tandem leg stance for first 2 weeks and then it was progressed to Single leg stance toe and heel stance.For dynamic balance:backward walk Tandem walk and sideways walk.

Strength and balance training

Aerobics training OTHER

After the baseline assessment, the participant in the Group B received Aerobic exercise with routine medical care. All patients were followed for 3 days a week for 8 weeks treatment. Control Group received aerobic training. Control group received stretching exercise for 10 minutes and then treadmill walk for 10 minutes and then stationary bicycle for 10 minutes, and steppers for 10 minutes and 5 minute cool down .

Aerobics training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes (diagnosed by physician)
• Patients with diabetic peripheral neuropathy (diagnosed by Diabetic neuropathy symptom score)
• Age limit 40 to 80 years
• Patients having Toronto neuropathy score 6 or greater

You may not qualify if:

• Patients having ulceration/infection of feet
• Medical/Surgical conditions limiting functional mobility
• Non-ambulatory patients
• Who are not willing to participate

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (10)

• Zhang XF, Tan BK. Effects of an ethanolic extract of Gynura procumbens on serum glucose, cholesterol and triglyceride levels in normal and streptozotocin-induced diabetic rats. Singapore Med J. 2000 Jan;41(1):9-13.

  PMID: 10783673 BACKGROUND

• Venkataraman K, Tai BC, Khoo EYH, Tavintharan S, Chandran K, Hwang SW, Phua MSLA, Wee HL, Koh GCH, Tai ES. Short-term strength and balance training does not improve quality of life but improves functional status in individuals with diabetic peripheral neuropathy: a randomised controlled trial. Diabetologia. 2019 Dec;62(12):2200-2210. doi: 10.1007/s00125-019-04979-7. Epub 2019 Aug 29.

  PMID: 31468106 BACKGROUND

• Davies M, Brophy S, Williams R, Taylor A. The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1518-22. doi: 10.2337/dc05-2228.

  PMID: 16801572 BACKGROUND

• Donoghue D; Physiotherapy Research and Older People (PROP) group; Stokes EK. How much change is true change? The minimum detectable change of the Berg Balance Scale in elderly people. J Rehabil Med. 2009 Apr;41(5):343-6. doi: 10.2340/16501977-0337.

  PMID: 19363567 BACKGROUND

• Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.

  PMID: 1468055 BACKGROUND

• Rojhani-Shirazi Z, Barzintaj F, Salimifard MR. Comparison the effects of two types of therapeutic exercises Frenkele vs. Swiss ball on the clinical balance measures in patients with type II diabetic neuropathy. Diabetes Metab Syndr. 2017 Nov;11 Suppl 1:S29-S32. doi: 10.1016/j.dsx.2016.08.020. Epub 2016 Sep 15.

  PMID: 27720359 BACKGROUND

• Dixit S, Maiya AG, Shastry BA. Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial. J Diabetes Complications. 2014 May-Jun;28(3):332-9. doi: 10.1016/j.jdiacomp.2013.12.006. Epub 2013 Dec 27.

  PMID: 24507164 BACKGROUND

• Billinger SA, Sisante JV, Alqahtani AS, Pasnoor M, Kluding PM. Aerobic exercise improves measures of vascular health in diabetic peripheral neuropathy. Int J Neurosci. 2017 Jan;127(1):80-85. doi: 10.3109/00207454.2016.1144056. Epub 2016 Feb 16.

  PMID: 26785723 BACKGROUND

• Yaribeygi H, Butler AE, Sahebkar A. Aerobic exercise can modulate the underlying mechanisms involved in the development of diabetic complications. J Cell Physiol. 2019 Aug;234(8):12508-12515. doi: 10.1002/jcp.28110. Epub 2019 Jan 8.

  PMID: 30623433 BACKGROUND

• Nomura T, Kawae T, Kataoka H, Ikeda Y. Assessment of lower extremity muscle mass, muscle strength, and exercise therapy in elderly patients with diabetes mellitus. Environ Health Prev Med. 2018 May 17;23(1):20. doi: 10.1186/s12199-018-0710-7.

  PMID: 29776338 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Aruba Saeed, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: March 19, 2021
• Study Start: March 30, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)