Effect of a tailored home-based exercise program in patients with systemic sclerosis: A randomized controlled trial

Mirko Filippetti, Lucia Cazzoletti, Francesco Zamboni, Pietro Ferrari, Cristian Caimmi, Nicola Smania, Stefano Tardivo, Marcello Ferrari, Mirko Filippetti, Lucia Cazzoletti, Francesco Zamboni, Pietro Ferrari, Cristian Caimmi, Nicola Smania, Stefano Tardivo, Marcello Ferrari

Abstract

Objective: The aim was to evaluate the effect of a home-based exercise program on functional capacity, health-related quality of life (HRQoL), and disability, in patients with systemic sclerosis (SSc).

Methods: A 6-month randomized controlled trial was conducted on SSc patients by comparing a home-based minimally supervised exercise program (exercise on a stationary cycle and strengthening of upper limbs; stretching of the hands) with usual care. At baseline and after 3 and 6 months, the patients underwent: 6 minutes walking test; hand mobility in scleroderma test; maximal exercise test on an ergocycle; strength measures (handgrip, quadriceps, and biceps). HRQoL (short-form 36 [SF-36]) and disability (health assessment questionnaire disability index [HAQ-DI]) were measured at the same time.

Results: Forty-four patients participated in the study. Twenty-two were randomly assigned to the intervention group (IG, mean age 63.60 ± 10.40 years) and 22 to the control group (CG, 61.80 ± 14.40 years). At 6 months, the distance walked in 6 minutes increased by 46 m (baseline 486, 95% CI 458-513 m; 6 months 532, 95% CI 504-561 m) in IG, whereas it decreased by 5 m (baseline 464, 95% CI 431-497 m; 6 months 459, 95% CI 427-490 m) in CG with a significantly different temporal trend at the between-groups comparison (P < .001). An improvement was also observed for strength measures (handgrip, P = .003; quadriceps, P < .001; biceps, P < .001), for the SF-36 physical component score (P < .001) and for the HAQ-DI (P = .011).

Conclusions: This study indicates that in SSc patients, a minimally supervised home-based exercise program improves physical performance, quality of life, and disability in comparison with usual care.

Keywords: disability; exercise therapy; muscles; quality of life; resistance training; scleroderma.

Conflict of interest statement

All the authors declare that they have no conflict of interest derived from the outcomes of this study.

© 2020 The Authors. Scandinavian Journal of Medicine & Science In Sports published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Flow diagram
Figure 2
Figure 2
Temporal trend of performance outcome measures of patients in IG and CG. Legend: The error bars represent the 95% confidence interval of the outcome estimates. *P ≤ .05 of time per group interaction. ● Intervention group (IG); ○ control group (CG)
Figure 3
Figure 3
Temporal trend in quality of life and disability outcome measures of patients in the IG and CG. Legend: SF‐36: short‐form 36; PCS: physical component score; MCS: mental component score; HAQ‐DI: health assessment questionnaire disability index. The error bars represent the 95% confidence interval of the outcome estimates. *P ≤ .05 of time per group interaction. ● Intervention group (IG); ○ control group (CG)

References

    1. Varga J, Abraham D. Systemic sclerosis. A prototypic multisystem fibrotic disorder. J Clin Invest. 2007;117:557‐567.
    1. Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009;360:1989‐2003.
    1. Morrisroe KB, Nikpour M, Proudman SM. Musculoskeletal manifestations of systemic sclerosis. Rheum Dis Clin North Am. 2015;41:507‐518.
    1. Caimmi C, Caramaschi P, Venturini A, et al. Malnutrition and sarcopenia in a large cohort of patients with systemic sclerosis. Clin Rheumatol. 2018;37(4):987‐997.
    1. Clements PJ, Furst DE, Campion DS, et al. Muscle disease in progressive systemic sclerosis: diagnostic and therapeutic considerations. Arthritis Rheum. 1978;21:62‐71.
    1. Almeida C, Almeida I, Vasconcelos C. Quality of life in systemic sclerosis. Autoimmun Rev. 2015;14:1087‐1096.
    1. Liem SIE, Meessen J, Wolterbeek R, et al. Physical activity in patients with systemic sclerosis. Rheumatol Int. 2018;38:443‐453.
    1. Mugii N, Hamaguchi Y, Maddali‐Bongi S. Clinical significance and usefulness of rehabilitation for systemic sclerosis. J Scleroderma Relat Disord. 2018;3:71‐80.
    1. Poole JL. Musculoskeletal rehabilitation in the person with scleroderma. Curr Opin Rheumatol. 2010;22:205‐212.
    1. De Oliveira NC, Portes LA, Pettersson H, Alexanderson H, Bostrom C. Aerobic and resistance exercise in systemic sclerosis: state of the art. Musculoskel Care. 2017;15:316‐323.
    1. Willems LM, Vriezekolk JE, Schouffoer AA, et al. Effectiveness of nonpharmacologic interventions in systemic sclerosis: a systematic review. Arthritis Care Res. 2015;67:1426‐1439.
    1. Rizzi M, Radovanovic D, Santus P, et al. Usefulness of six‐minute walk test in systemic sclerosis. Clin Exp Rheumatol. 2018;113:161‐167.
    1. Martis N, Queyrel‐Moranne V, Launay D, et al. Limited exercise capacity in patients with systemic sclerosis: identifying contributing factors with cardiopulmonary exercise testing. J Rheumatol. 2018;45:95‐102.
    1. van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Arthritis Rheum. 2013;65:2737‐2747.
    1. The Criteria Committee of the New York Heart Association . the criteria committee of the New York Heart Association: nomenclature and criteria for diagnosis of diseases of the heart and great blood vessels. Am Heart J. 1974;88:679.
    1. National kidney foundation . K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39:1‐266.
    1. Clements P, Lachenbruch P, Siebold J, et al. Inter and intraobserver variability of total skin thickness score (modified Rodnan TSS) in systemic sclerosis. J Rheumatol. 1995;22:1281‐1285.
    1. Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J. 2005;26:319‐338.
    1. Cossutta R, Zeni S, Soldi A, Colombelli P, Belotti Masserini A, Fantini F. Evaluation of quality of life in patients with systemic sclerosis by administering the Sf‐36 questionnaire. Reumatismo. 2002;54:122‐127.
    1. Poole JL, Steen VD. The use of the Health Assessment Questionnaire (HAQ) to determine physical disability in systemic sclerosis. Arthritis Care Res. 1991;4:27‐31.
    1. Sandqvist G, Eklund M. Validity of HAMIS: a test of hand mobility in scleroderma. Arthritis Care Res. 2000;13:382‐387.
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories . ATS statement: guidelines for the six‐minute walk test. Am J Respir Crit Care Med. 2002;166:111‐117.
    1. Ranza R, Marchesoni A, Calori G, et al. The Italian version of the Functional Disability Index of the Health Assessment Questionnaire. A reliable instrument for multicenter studies on rheumatoid arthritis. Clin Exp Rheumatol. 1993;11:123‐128.
    1. Apolone G, Mosconi P. The Italian SF‐36. Health Survey: translation, validation and norming. J Clin Epidemiol. 1998;51:1025‐1036.
    1. Del Rosso A, Maddali‐Bongi S, Sigismondi F, Miniati I, Bandinelli F, Matucci‐Cerinic M. The Italian version of the Hand Mobility in Scleroderma (HAMIS) test: evidence for its validity and reliability. Clin Exp Rheumatol. 2010;28:42‐47.
    1. American Thoracic Society; American College of Chest Physicians . ATS/ACCP statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003;167:211‐277.
    1. American College of Sports Medicine . American College of Sports Medicine: ACSM’s Guidelines for Exercise Testing and Prescription, 9th edition Philadelphia, PA: Kluwer/Lippincott Williams & Wilkins; 2014.
    1. Brzycki M. A Practical Approach to Strength Training. New York: McGraw‐Hill; 1998.
    1. Chow SC, And SJ, Wang H. Sample Size Calculations in Clinical Research, 2nd edn Boca Raton, FL: Chapman & Hall/Crc; 2008.
    1. Sekhon S, Pope J, Baron M. The minimally important difference in clinical practice for patient‐centered outcomes including health assessment questionnaire, fatigue, pain, sleep, global visual analog scale, and SF‐36 in scleroderma. J Rheumatol. 2010;37:591‐598.
    1. Lóránd V, Czirják L, Minier T. Musculoskeletal involvement in systemic sclerosis. Presse Med. 2014;43:315‐328.
    1. Oliveira NC, Dos Santos Sabbag LM, De Sá Pinto AL, Borges CL, Lima FR. Aerobic exercise is safe and effective in systemic sclerosis. Int J Sports Med. 2009;30:728‐732.
    1. Pinto ALS, Oliveira NC, Gualano B, et al. Efficacy and safety of concurrent training in systemic sclerosis. J Strength Cond Res. 2011;25:1423‐1428.
    1. Antonioli CM, Bua G, Frigè A, et al. An individualized rehabilitation program in patients with systemic sclerosis may improve quality of life and hand mobility. Clin Rheumatol. 2009;28:159‐165.
    1. Schouffoer AA, Schoones JV, Terwee CB, Vliet Vlieland TPM. Work status and its determinants among patients with Systemic Sclerosis: a systematic review. Rheumatology (Oxford). 2012;51(7):1304‐1314. 10.1093/rheumatology/ker523.
    1. Lima TR, Guimarães FS, Carvalho MN, Sousa TL, Menezes SL, Lopes AJ. Lower limb muscle strength is associated with functional performance and quality of life in patients with systemic sclerosis. Braz J Phys Ther. 2015;19:129‐136.
    1. Justo AC, Guimarães FS, Ferreira AS, Soares MS, Bunn PS, Lopes AJ. Muscle function in women with systemic sclerosis: association with fatigue and general physical function. Clin Biomech (Bristol, Avon). 2017;47:33‐39.
    1. Pownall HJ, Bray GA, Wagenknecht LE, et al. Changes in body composition over 8 years in a randomized trial of a lifestyle intervention: the look AHEAD study. Obesity (Silver Spring). 2015;23:565‐572.
    1. Jewett LR, Hudson M, Malcarne VL, Baron M, Thombs BD; Canadian Scleroderma Research Group . Sociodemographic and disease correlates of body image distress among patients with systemic sclerosis. PLoS ONE. 2012;7:33281.
    1. Malcarne VL, Fox RS, Mills SD, Gholizadeh S. Psychosocial aspects of systemic sclerosis. Curr Opin Rheumatol. 2013;25:707‐713.
    1. Rannou F, Boutron I, Mouthon L, et al. Personalized physical therapy versus usual care for patients with systemic sclerosis: a randomized controlled trial. Arthritis Care Res (Hoboken). 2017;69:1050‐1059.

Source: PubMed

3
Subscribe