Department of Rehabilitation Science and Health Technology, Faculty of Health Science, OsloMet - Oslo Metropolitan University, Oslo, Norway.
Department of Nursing, Lovisenberg Diaconal University College, Oslo, Norway.
BMC Neurol. 2023 Mar 2;23(1):93. doi: 10.1186/s12883-023-03134-5.
Although it is well known that regular physical activity and exercise, as well as maintaining adequate nutritional status is important to delaying symptom development and maintaining physical capacity and function in people with Parkinson's Disease (PD), many are unable to follow self-management recommendations. Active interventions have shown short-term effects, but there is a need for interventions that facilitate self-management over the course of the disease. Until now, no studies have combined exercise and nutritional interventions with an individual self-management approach in PD. Thus, we aim to examine the effect of a six-month mobile health technology(m-health)-based follow-up programme, focusing on self-management in exercise and nutrition, after an in-service interdisciplinary rehabilitation programme.
A single-blinded, two-group randomised controlled trial. Participants are Adults aged 40 or older, with idiopathic PD, Hoehn and Yahr 1-3, living at home. The intervention group receives a monthly, individualized, digital conversation with a PT, combined with use of an activity tracker. People at nutritional risk get additional digital-follow-up from a nutritional specialist. The control group receives usual care. The primary outcome is physical capacity, measured by 6-min walk test (6MWT). Secondary outcomes are nutritional status, Health related quality of life (HRQOL), physical function and exercise adherence. All measurements are performed at baseline, after 3 months and after 6 months. Sample size, based on primary outcome, is set at 100 participants randomized into the two arms, including an estimated 20% drop out.
The increasing prevalence of PD globally makes it even more important to develop evidence-based interventions that can increase motivation to stay active, promote adequate nutritional status and improve self-management in people with PD. The individually tailored digital follow-up programme, based on evidence-based practice, has the potential to promote evidence-based decision-making and to empower people with PD to implement exercise and optimal nutrition in their daily lives and, hopefully, increase adherence to exercise and nutritional recommendations.
ClinicalTrials.gov (NCT04945876). First registration 01.03.2021.
尽管众所周知，定期进行身体活动和锻炼以及保持充足的营养状态对于延缓帕金森病（PD）患者的症状发展以及维持身体能力和功能非常重要，但许多人无法遵循自我管理建议。积极的干预措施已显示出短期效果，但需要一种能够在疾病过程中促进自我管理的干预措施。到目前为止，还没有研究将运动和营养干预与 PD 中的个体自我管理方法相结合。因此，我们旨在研究经过在职跨学科康复计划后，使用基于移动健康技术（m-health）的为期六个月的随访计划，重点关注运动和营养方面的自我管理，对其效果进行检验。
这是一项单盲、两臂随机对照试验。参与者为年龄在 40 岁或以上、患有特发性 PD、Hoehn 和 Yahr 1-3 级、居家生活的成年人。干预组每月接受一次与物理治疗师的个性化数字对话，并结合使用活动追踪器。有营养风险的人会从营养专家那里获得额外的数字随访。对照组接受常规护理。主要结局是身体能力，通过 6 分钟步行测试（6MWT）进行测量。次要结局是营养状况、健康相关生活质量（HRQOL）、身体功能和运动依从性。所有测量均在基线、3 个月和 6 个月时进行。根据主要结局，设定了 100 名参与者随机分配到两个组的样本量，预计有 20%的脱落率。
PD 在全球的患病率不断上升，因此开发能够提高积极性以保持活跃、促进充足营养状态和改善 PD 患者自我管理的循证干预措施变得更加重要。基于循证实践的个体化定制数字随访计划具有促进循证决策的潜力，并使 PD 患者能够在日常生活中实施运动和最佳营养，并希望提高对运动和营养建议的依从性。
ClinicalTrials.gov（NCT04945876）。首次注册日期为 2021 年 3 月 1 日。
