Clinical trial NCT03964363: Home-based Prehabilitation for Elderly Patients
Official title: Pre-operative Physical Training for Elderly Patients with Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: Frailty
preoperative period
surgery
breathing exercise
postoperative complications
resistance training
endurance training
anaesthesia
activities of daily living
patient reported outcome
prehabilitation
perioperative care
elderly
prevention
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 512
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This trail is designed as a prospective, multicentre, randomized controlled study with two parallel groups with a total of four arms. Patients with a scheduled elective surgery will be randomly assigned into treatment and control group after having been screened for frailty. A subgroup will be formed by patients who will receive a transcatheter aortic valve implantation (TAVI). The preventative effect of a behaviour modification will subsequently be compared.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of recovery: QoR-15
timeFrame: 7 days postoperative
Secondary outcomes:
measure: Quality of recovery: QoR-15
timeFrame: 3 months postoperative
measure: Health related quality of life: Questionnaire Short Form-12 (SF-12)
timeFrame: preoperative, 3 months postoperative
measure: Activities of daily living
timeFrame: preoperative, 7 days and 3 months postoperative
measure: Cognitive performance
timeFrame: preoperative, 7 days and 3 months postoperative
measure: Mobility
timeFrame: preoperative, 3 months postoperative
measure: Muscle strength
timeFrame: preoperative, 7 days postoperative
measure: Incidence of postoperative complications
timeFrame: preoperative, 7 days and 3 months postoperative
measure: Duration of hospital admission
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: München
country: Germany
facility: Rotkreuzklinikium München
state: Bayern
city: Hamburg
country: Germany
facility: University Medical Center Eppendorf
city: Hamburg
country: Germany
facility: Agaplesion Diakonieklinikum Hamburg
Study officials:
affiliation: Department of Anaesthesiology, University Medical Center Eppendorf
name: Cynthia Olotu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
citation: Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
citation: Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.