背景:慢性脊髓损伤(SCI)显着加速发病率和死亡率,部分原因是心脏代谢疾病(CMD)的风险增加,包括神经性肥胖,血脂异常,和葡萄糖代谢受损。虽然运动和饮食干预在降低CMD风险方面显示出一些短暂的益处,它们通常不能改善临床相关疾病标志物和心血管事件.此外,SCI还对护理人员提出了护理要求,他们自己经历健康和功能衰退。这强调了需要更多实质性的干预措施,包括适当的身体活动,心脏健康的营养,和为SCI人群量身定制的行为支持。
目的:这项随机临床试验(RCT)方案将(1)评估健康和功能的影响,用户接受,为慢性SCI患者改编自国家糖尿病预防计划(DPP)的6个月综合治疗生活方式干预(TLI)的满意度和(2)检查补充护理人员计划对SCI护理人员的健康和功能的影响,并评估用户的接受度和满意度。照顾者(与他们的伴侣联系)将被随机分配到“行为支持”或“控制条件”。
方法:二元夫妇包括SCI患者(18-65岁,>受伤后1年,亚洲减损量表A-C,损伤水平C5-L1)和非残疾SCI护理人员(18-65岁)。两组均接受锁步电路阻力训练,限制热量的地中海式饮食,和16个教育课程,重点是饮食/运动目标,自我监控,心理和社会挑战,认知行为疗法,和励志面试。结果测量包括心脏代谢风险,心肺健康,炎性应激,多维函数,疼痛,生活质量,独立性,自我效能感,程序验收,SCI参与者的生活满意度。护理人员的结果包括多维功能,疼痛,生活质量,独立性,和感知到的照顾者负担。
结论:本研究评估了结构化,健康和功能的多模式干预。结果和干预材料将分发给专业人员和消费者,以便更广泛地实施。
背景:ClinicalTrials.gov,ID:NCT028531492016年8月2日注册。
Chronic spinal cord injury (SCI) significantly accelerates morbidity and mortality, partly due to the increased risk of cardiometabolic diseases (CMD), including neurogenic obesity, dyslipidemia, and impaired glucose metabolism. While exercise and dietary interventions have shown some transient benefits in reducing CMD risk, they often fail to improve clinically relevant disease markers and cardiovascular events. Moreover, SCI also places caregiving demands on their caregivers, who themselves experience health and functional decline. This underscores the need for more substantial interventions that incorporate appropriate physical activity, heart-healthy nutrition, and behavioral support tailored to the SCI population.
This randomized clinical trial (RCT) protocol will (1) assess the health and functional effects, user acceptance, and satisfaction of a 6-month comprehensive therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI and (2) examine the impact of a complementary caregiver program on the health and function of SCI caregivers and evaluate user acceptance and satisfaction. Caregivers (linked with their partners) will be randomized to \'behavioral support\' or \'control condition\'.
Dyadic couples comprise individuals with SCI (18-65 years, >1-year post-injury, ASIA Impairment Scale A-C, injury levels C5-L1) and non-disabled SCI caregivers (18-65 years). Both groups undergo lock-step circuit resistance training, a calorie-restricted Mediterranean-style diet, and 16 educational sessions focused on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing. The outcome measures encompass the cardiometabolic risks, cardiorespiratory fitness, inflammatory stress, multidimensional function, pain, life quality, independence, self-efficacy, program acceptance, and life satisfaction for SCI participants. The caregiver outcomes include multidimensional function, pain, quality of life, independence, and perceived caregiver burden.
This study evaluates the effects and durability of a structured, multi-modal intervention on health and function. The results and intervention material will be disseminated to professionals and consumers for broader implementation.
ClinicalTrials.gov, ID: NCT02853149 Registered 2 August 2016.