Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program

Официальное название

Assessment of the Level of Physical Activity and Sedentarism of Stroke Survivors in the Valencian Community and Development of a Specific Self-management Program

Обзор

Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account. Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty. To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.

Вмешательства

• Другое Self-management program to increase physical activity levels
  Information and Communication Technologies will be used to carry out various remote sessions. The sessions will address important issues to promote self-management of sedentary lifestyle by stroke survivors. Additionally, a peer support group will be created in order to improve adherence to the program.
• Другое Education information
  Education on the importance of active lifestyle habits post-stroke.

Первичные конечные точки

• Change from Baseline Physical activity level at a year [Срок оценки: 1 year]
• Change from Baseline Sedentary time at a year [Срок оценки: 1 year]

Вторичные конечные точки (7)

• Change from Baseline Functional Mobility at a year [Срок оценки: 1 year]
• Change from Baseline Lower extremity functioning at a year [Срок оценки: 1 year]
• Change from Baseline Postural stability in standing at a year [Срок оценки: 1 year]
• Change from Baseline Frailty at a year [Срок оценки: 1 year]
• Change from Baseline Sarcopenia at a year [Срок оценки: 1 year]
• Change from Baseline Bone mineral density at a year [Срок оценки: 1 year]
• Change from Baseline Motion analysis at a year [Срок оценки: 1 year]

Критерии участия

Критерии включения

• having sequelae after stroke of at least 6 months of evolution
• being community-dwelling (minimum 2 months since the last stroke)
• having the ability to walk around the house with or without technical aids but without requiring supervision from another person (FACHS ≥ 2)
• having enough cognitive capacity to provide informed consent and to understand and answer the questions proposed

Критерии исключения

• not having a strength deficit in the lower limbs or walking difficulties
• having poor vital prognosis or suffering from other pathologies or disorders that may alter the development of the study (blindness, severe sensitivity alteration, musculoskeletal or cardiovascular conditions that contraindicate the performance of physical activity...)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Department of Physiotherapy. University of Valencia — Valencia
• University of Valencia — Valencia

Публикации

• Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014. PMID 24505342
• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ PMID 24352519
• Lynch EA, Jones TM, Simpson DB, Fini NA, Kuys SS, Borschmann K, Kramer S, Johnson L, Callisaya ML, Mahendran N, Janssen H, English C; ACTIOnS Collaboration. Activity monitors for increasing physical activity in adult stroke survivors. Cochrane Database Syst Rev. 2018 Jul 27;7(7):CD012543. doi: 10.1002/14651858.CD012543.pub2. PMID 30051462
• Howe MD, McCullough LD. Prevention and management of stroke in women. Expert Rev Cardiovasc Ther. 2015 Apr;13(4):403-15. doi: 10.1586/14779072.2015.1020300. Epub 2015 Mar 6. PMID 25747877
• Bushnell CD, Reeves MJ, Zhao X, Pan W, Prvu-Bettger J, Zimmer L, Olson D, Peterson E. Sex differences in quality of life after ischemic stroke. Neurology. 2014 Mar 18;82(11):922-31. doi: 10.1212/WNL.0000000000000208. Epub 2014 Feb 7. PMID 24510493
• Mackie P, Weerasekara I, Crowfoot G, Janssen H, Holliday E, Dunstan D, English C. What is the effect of interrupting prolonged sitting with frequent bouts of physical activity or standing on first or recurrent stroke risk factors? A scoping review. PLoS One. 2019 Jun 13;14(6):e0217981. doi: 10.1371/journal.pone.0217981. eCollection 2019. PMID 31194799
• Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, Shephard T; American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Physical activity and exercise recommendations for stroke survivors: an A PMID 15105522
• Prior PL, Suskin N. Exercise for stroke prevention. Stroke Vasc Neurol. 2018 Jun 26;3(2):59-68. doi: 10.1136/svn-2018-000155. eCollection 2018 Jun. PMID 30191075

Идентификаторы

NCT: NCT04576598 · GV/2019/161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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