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

Kavita Venkataraman, Bee Choo Tai, Eric Y H Khoo, Subramaniam Tavintharan, Kurumbian Chandran, Siew Wai Hwang, Melissa S L A Phua, Hwee Lin Wee, Gerald C H Koh, E Shyong Tai, Kavita Venkataraman, Bee Choo Tai, Eric Y H Khoo, Subramaniam Tavintharan, Kurumbian Chandran, Siew Wai Hwang, Melissa S L A Phua, Hwee Lin Wee, Gerald C H Koh, E Shyong Tai

Abstract

Aims/hypothesis: The aim of this study was to test the effectiveness of a structured strength and balance training intervention in improving health-related quality of life (HRQoL) and functional status in individuals with diabetic peripheral neuropathy (DPN).

Methods: The study was a single-blind parallel-group randomised controlled trial comparing 2 months of once-weekly home-based strength and balance training against standard medical therapy. Participants were patients with physician-diagnosed type 2 diabetes and neuropathy recruited from five public sector institutions in Singapore between July 2014 and October 2017. Participants were block-randomised to intervention or control arms. Outcomes were assessed at baseline, 2 months and 6 months by a trained assessor blinded to group assignment. Primary outcomes were change in physical component summary (PCS) score of SF-36v2 (a 36-item generic HRQoL instrument that has been validated for use in Singapore) and EQ-5D-5L index score (derived from a five-item generic HRQoL instrument [EQ-5D-5L]) over 6 months. Secondary outcomes were change in functional status (timed up-and-go [TUG], five times sit-to-stand [FTSTS], functional reach, static balance, ankle muscle strength and knee range of motion) and balance confidence over 6 months. Mean differences in scores between groups were compared using mixed models.

Results: Of the 143 participants randomised (intervention, n = 70; control, n = 73), 67 participants were included in each arm for the final intention-to-treat analysis. The two groups were similar, except in terms of sex. There were no significant differences between groups on the primary outcomes of PCS score (mean difference [MD] 1.56 [95% CI -1.75, 4.87]; p = 0.355) and EQ-5D-5L index score (MD 0.02 [95% CI -0.01, 0.06]; p = 0.175). There were significant improvements in TUG test performance (MD -1.14 [95% CI -2.18, -0.1] s; p = 0.032), FTSTS test performance (MD -1.31 [95% CI -2.12, -0.51] s; p = 0.001), ankle muscle strength (MD 4.18 [95% CI 0.4, 7.92] N; p = 0.031), knee range of motion (MD 6.82 [95% CI 2.87, 10.78]°; p = 0.001) and balance confidence score (MD 6.17 [95% CI 1.89, 10.44]; p = 0.005). No adverse events due to study participation or study intervention were reported.

Conclusions/interpretation: Short-term structured strength and balance training did not influence HRQoL but produced sustained improvements in functional status and balance confidence at 6 months. More intensive interventions may be needed to influence HRQoL in these individuals. However, this intervention may be a useful treatment option for individuals with DPN to reduce the risk of falls and injuries.

Trial registration: ClinicalTrials.gov NCT02115932 FUNDING: This work was supported by the National Medical Research Council, Singapore.

Keywords: Balance; Diabetes; Diabetic neuropathy; Functional ability; Muscle strength; Physical therapy; Quality of life.

Figures

Fig. 1
Fig. 1
Time trends in selected outcomes in intervention and control groups: (a) PCS score (primary outcome); (b) FTSTS (secondary outcome); (c) muscle strength at right ankle (secondary outcome); and (d) ABC score (secondary outcome)

References

    1. Tesfaye S, Boulton AJ, Dyck PJ, et al. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010;33(10):2285–2293. doi: 10.2337/dc10-1303.
    1. Venkataraman K, Wee HL, Leow MK, et al. Associations between complications and health-related quality of life in individuals with diabetes. Clin Endocrinol. 2013;78(6):865–873. doi: 10.1111/j.1365-2265.2012.04480.x.
    1. Dyck PJ, Kratz KM, Karnes JL, et al. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993;43(4):817–824. doi: 10.1212/WNL.43.4.817.
    1. Boyko EJ, Ahroni JH, Stensel V, Forsberg RC, Davignon DR, Smith DG. A prospective study of risk factors for diabetic foot ulcer. The Seattle Diabetic Foot Study. Diabetes Care. 1999;22(7):1036–1042. doi: 10.2337/diacare.22.7.1036.
    1. McNeely MJ, Boyko EJ, Ahroni JH, et al. The independent contributions of diabetic neuropathy and vasculopathy in foot ulceration. How great are the risks? Diabetes Care. 1995;18(2):216–219. doi: 10.2337/diacare.18.2.216.
    1. Venkataraman K, Tan LS, Bautista DC, et al. Psychometric properties of the Problem Areas in Diabetes (PAID) instrument in Singapore. PLoS One. 2015;10(9):e0136759. doi: 10.1371/journal.pone.0136759.
    1. Benbow SJ, Wallymahmed ME, MacFarlane IA. Diabetic peripheral neuropathy and quality of life. QJM. 1998;91(11):733–737. doi: 10.1093/qjmed/91.11.733.
    1. Van Acker K, Bouhassira D, De Bacquer D, et al. Prevalence and impact on quality of life of peripheral neuropathy with or without neuropathic pain in type 1 and type 2 diabetic patients attending hospital outpatients clinics. Diabetes Metab. 2009;35(3):206–213. doi: 10.1016/j.diabet.2008.11.004.
    1. OʼConnor AB. Neuropathic pain: quality-of-life impact, costs and cost effectiveness of therapy. PharmacoEconomics. 2009;27(2):95–112. doi: 10.2165/00019053-200927020-00002.
    1. Happich M, John J, Stamenitis S, Clouth J, Polnau D. The quality of life and economic burden of neuropathy in diabetic patients in Germany in 2002--results from the Diabetic Microvascular Complications (DIMICO) study. Diabetes Res Clin Pract. 2008;81(2):223–230. doi: 10.1016/j.diabres.2008.03.019.
    1. Currie CJ, Poole CD, Woehl A, et al. The health-related utility and health-related quality of life of hospital-treated subjects with type 1 or type 2 diabetes with particular reference to differing severity of peripheral neuropathy. Diabetologia. 2006;49(10):2272–2280. doi: 10.1007/s00125-006-0380-7.
    1. Bruce DG, Davis WA, Davis TM. Longitudinal predictors of reduced mobility and physical disability in patients with type 2 diabetes: the Fremantle Diabetes Study. Diabetes Care. 2005;28(10):2441–2447. doi: 10.2337/diacare.28.10.2441.
    1. Volpato S., Blaum C., Resnick H., Ferrucci L., Fried L. P., Guralnik J. M. Comorbidities and Impairments Explaining the Association Between Diabetes and Lower Extremity Disability: The Women's Health and Aging Study. Diabetes Care. 2002;25(4):678–683. doi: 10.2337/diacare.25.4.678.
    1. Simoneau GG, Derr JA, Ulbrecht JS, Becker MB, Cavanagh PR. Diabetic sensory neuropathy effect on ankle joint movement perception. Arch Phys Med Rehabil. 1996;77(5):453–460. doi: 10.1016/S0003-9993(96)90033-7.
    1. Martinelli AR, Mantovani AM, Nozabieli AJ, et al. Muscle strength and ankle mobility for the gait parameters in diabetic neuropathies. Foot (Edinb) 2013;23(1):17–21. doi: 10.1016/j.foot.2012.11.001.
    1. Mueller MJ, Minor SD, Sahrmann SA, Schaaf JA, Strube MJ. Differences in the gait characteristics of patients with diabetes and peripheral neuropathy compared with age-matched controls. Phys Ther. 1994;74(4):299–308. doi: 10.1093/ptj/74.4.299.
    1. Simoneau GG, Ulbrecht JS, Derr JA, Becker MB, Cavanagh PR. Postural instability in patients with diabetic sensory neuropathy. Diabetes Care. 1994;17(12):1411–1421. doi: 10.2337/diacare.17.12.1411.
    1. Richardson JK, Sandman D, Vela S. A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy. Arch Phys Med Rehabil. 2001;82(2):205–209. doi: 10.1053/apmr.2001.19742.
    1. Allet L, Armand S, de Bie RA, et al. The gait and balance of patients with diabetes can be improved: a randomised controlled trial. Diabetologia. 2010;53(3):458–466. doi: 10.1007/s00125-009-1592-4.
    1. Allet L., Armand S., Aminian K., Pataky Z., Golay A., de Bie R.A., de Bruin E.D. An exercise intervention to improve diabetic patients’ gait in a real-life environment. Gait & Posture. 2010;32(2):185–190. doi: 10.1016/j.gaitpost.2010.04.013.
    1. Dixit S, Maiya A, Shastry B. Effect of aerobic exercise on quality of life in population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, randomized controlled trial. Qual Life Res. 2014;23(5):1629–1640. doi: 10.1007/s11136-013-0602-7.
    1. Riandini T, Wee HL, Khoo EYH, et al. Functional status mediates the association between peripheral neuropathy and health-related quality of life in individuals with diabetes. Acta Diabetol. 2018;55(2):155–164. doi: 10.1007/s00592-017-1077-8.
    1. Vileikyte L, Leventhal H, Gonzalez JS, et al. Diabetic peripheral neuropathy and depressive symptoms: the association revisited. Diabetes Care. 2005;28(10):2378–2383. doi: 10.2337/diacare.28.10.2378.
    1. Young MJ, Breddy JL, Veves A, Boulton AJ. The prediction of diabetic neuropathic foot ulceration using vibration perception thresholds. A prospective study. Diabetes Care. 1994;17(6):557–560. doi: 10.2337/diacare.17.6.557.
    1. Kumar S, Fernando DJ, Veves A, Knowles EA, Young MJ, Boulton AJ. Semmes-Weinstein monofilaments: a simple, effective and inexpensive screening device for identifying diabetic patients at risk of foot ulceration. Diabetes Res Clin Pract. 1991;13(1–2):63–67. doi: 10.1016/0168-8227(91)90034-B.
    1. Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care. 1994;17(11):1281–1289. doi: 10.2337/diacare.17.11.1281.
    1. World Health Organization (2001) AUDIT: the alcohol use disorders identification test: guidelines for use in primary care. In: Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, 2nd edn. World Health Organization. Available from . Accessed 20 May 2013
    1. Allen MD, Choi IH, Kimpinski K, Doherty TJ, Rice CL. Motor unit loss and weakness in association with diabetic neuropathy in humans. Muscle Nerve. 2013;48(2):298–300. doi: 10.1002/mus.23792.
    1. Manor B, Li L. Characteristics of functional gait among people with and without peripheral neuropathy. Gait Posture. 2009;30(2):253–256. doi: 10.1016/j.gaitpost.2009.04.011.
    1. Thumboo J, Wu Y, Tai ES, et al. Reliability and validity of the English (Singapore) and Chinese (Singapore) versions of the short-form 36 version 2 in a multi-ethnic urban Asian population in Singapore. Qual Life Res. 2013;22(9):2501–2508. doi: 10.1007/s11136-013-0381-1.
    1. Shiroiwa T, Ikeda S, Noto S, et al. Comparison of value set based on DCE and/or TTO data: scoring for EQ-5D-5L health states in Japan. Value Health. 2016;19(5):648–654. doi: 10.1016/j.jval.2016.03.1834.
    1. Copay AG, Subach BR, Glassman SD, Polly DW, Jr, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7(5):541–546. doi: 10.1016/j.spinee.2007.01.008.
    1. Gu Y, Dennis SM. Are falls prevention programs effective at reducing the risk factors for falls in people with type-2 diabetes mellitus and peripheral neuropathy: a systematic review with narrative synthesis. J Diabetes Complicat. 2017;31(2):504–516. doi: 10.1016/j.jdiacomp.2016.10.004.
    1. Mueller MJ, Tuttle LJ, Lemaster JW, et al. Weight-bearing versus nonweight-bearing exercise for persons with diabetes and peripheral neuropathy: a randomized controlled trial. Arch Phys Med Rehabil. 2013;94(5):829–838. doi: 10.1016/j.apmr.2012.12.015.
    1. Johansson B, Brandberg Y, Hellbom M, et al. Health-related quality of life and distress in cancer patients: results from a large randomised study. Br J Cancer. 2008;99(12):1975–1983. doi: 10.1038/sj.bjc.6604789.
    1. Yoo M, D’Silva LJ, Martin K, et al. Pilot study of exercise therapy on painful diabetic peripheral neuropathy. Pain Med (Malden, Mass) 2015;16(8):1482–1489. doi: 10.1111/pme.12743.
    1. Kluding PM, Pasnoor M, Singh R, et al. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complicat. 2012;26(5):424–429. doi: 10.1016/j.jdiacomp.2012.05.007.
    1. Chapman A, Meyer C, Renehan E, Hill KD, Browning CJ. Exercise interventions for the improvement of falls-related outcomes among older adults with diabetes mellitus: a systematic review and meta-analyses. J Diabetes Complicat. 2017;31(3):631–645. doi: 10.1016/j.jdiacomp.2016.09.015.
    1. Curtze C, Nutt JG, Carlson-Kuhta P, Mancini M, Horak FB. Objective gait and balance impairments relate to balance confidence and perceived mobility in people with Parkinson disease. Phys Ther. 2016;96(11):1734–1743. doi: 10.2522/ptj.20150662.
    1. Torkia C, Best KL, Miller WC, Eng JJ. Balance confidence: a predictor of perceived physical function, perceived mobility, and perceived recovery 1 year after inpatient stroke rehabilitation. Arch Phys Med Rehabil. 2016;97(7):1064–1071. doi: 10.1016/j.apmr.2016.03.004.
    1. (2019) 11. Microvascular complications and foot care: standards of medical care in diabetes-2019. Diabetes care 42(Suppl 1): S124-S138. 10.2337/dc19-S011

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