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临床试验/NCT03964363
NCT03964363已完成不适用

Pre-operative Physical Training for Elderly Patients With Frailty

Universitätsklinikum Hamburg-Eppendorf6 个研究点 分布在 1 个国家目标入组 512 人开始时间: 2019年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
512
试验地点
6
主要终点
Quality of recovery: QoR-15

研究概览

简要总结

As a consequence of the increasing life expectancy hospitals are seeing a growing number of elderly patients undergoing elective surgery. These patients are likely to suffer from one or more chronic illnesses, malnutrition, reduced physical strength and mobility and sensory impairment. Age related loss of resilience in combination with these conditions often results in frailty. Frailty syndrome describes a reduction in weight, mobility and strength, as well as declining cognitive capacities and reduced performance in daily life activities. This decline in constitution is accompanied by an increased risk of complications and mortality in the period after surgery. Frail patients are generally admitted to hospital for a longer period and are readmitted more often.

A multitude of studies has demonstrated that these risks can be significantly reduced by offering frail patients a prevention program prior to their surgery. These prevention programs are often referred to as prehabilitation and combine strength and cardiovascular training with breathing exercises. Despite the obvious benefits, prehabilitation programs are not yet commonly applied outside of research settings as they carry considerable costs and required additional skilled personnel.

In response to the unmet need for a widely applicable, cost and personnel efficient prehabilitation program a home-based prehabilitation program has been designed. This prehabilitation allows patients to safely perform an individualised set of exercises without relying on a personal trainer or a training group. Efficiency and feasibility will be evaluated in this study.

详细描述

The average age of hospital patients has steadily increased with the demographic change of Germany's ageing population. In 2014, more than 27 million people living in Germany were older than 60 years and more than one third of this group had to undergo surgery within that year.

A relevant proportion of this patient group has to be considered frail or pre-frail. Over a lifetime every individual experiences a physiological reduction of functional capacity across all organ systems resulting in frailty. Consequently, physical and psychological stress, such as a hospital stay and surgery cannot be readily compensated. Therefore, frailty is a highly predictive pre-operative risk factor for increased post-operative morbidly and mortality, prolonged hospital stay and loss of independence. Multiple studies have demonstrated post-operative outcome of frail patients can be drastically improved if these patients are identified prior to elective surgery and enrolled in a multimodal prehabilitation program. The core of prehabilitation is physical exercise next to nutritional and psychological support. The improvement of cardiovascular condition, ventilator capacity and muscle strength gained during prehabilitation resulted in a reduced incidence of complications including pneumonia, shorter hospital stays and improved quality of life. Yet despite these benefits prehabilitation is not yet widely available outside of clinical studies as they carry considerable costs and demand additional skilled personnel.

In order to provide prehabilitation to a larger group of patients, a pre-operative exercise program was developed, that can safely be followed by pre-frail and frail patients at home without the need of continuous instruction and supervision by a trainer or physiotherapist. Efficacy and feasibility will be evaluated in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • pre-frail or frail according to (Longitudinal Urban Cohort Ageing Study) LUCAS-functional index
  • scheduled for elective surgery
  • planned ward admission for at least 24h after surgery

排除标准

  • Refusal of participation
  • Presentation less than 2 weeks prior to scheduled procedure
  • Pre-existing pronounced immobility (wheelchair bound, paresis of both arms or both legs)
  • Minor surgical interventions such as small excisions of superficial tissues, small interventions for haemorrhoids, curettage, gastroscopy

研究组 & 干预措施

Prehabilitation

Experimental

Participants are scheduled for elective surgery and follow the home-based prehabilitation for 11-17 days

干预措施: Unsupervised home-based physical prehabilitation (Behavioral)

Prehabilitation + TAVI

Experimental

Study participants who will undergo a TAVI form a subgroup with a modified enrolment procedure and longer duration of the intervention. The prehabilitation period is extended to 30 days.

干预措施: Unsupervised home-based physical prehabilitation (Behavioral)

Control

No Intervention

Participants are initially evaluated for frailty prior to scheduled surgery but subsequently receive regular care without a prehabilitation program. All pre- and postsurgical evaluations will be identical to the prehabilitation group.

Control+TAVI

No Intervention

The subgroup of participants who undergo a TAVI will be compared to a group of patients who will have had the same procedure. Hence the control group will also receive a screening via phone but then receive regular care. Follow-up after surgery will be identical in all groups.

结局指标

主要结局

Quality of recovery: QoR-15

时间窗: 7 days postoperative

The quality of recovery after surgery and anaesthesia is measured using the QoR-15 questionnaire. The resulting score indicates self-reported patent well-being and perceived support with higher scores (0-100) indicating a better quality of recovery. (8)

次要结局

  • Quality of recovery: QoR-15(3 months postoperative)
  • Health related quality of life: Questionnaire Short Form-12 (SF-12)(preoperative, 3 months postoperative)
  • Duration of hospital admission(3 months postoperative)
  • Mobility(preoperative, 3 months postoperative)
  • Incidence of postoperative complications(preoperative, 7 days and 3 months postoperative)
  • Cognitive performance(preoperative, 7 days and 3 months postoperative)
  • Activities of daily living(preoperative, 7 days and 3 months postoperative)
  • Muscle strength(preoperative, 7 days postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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