Home-based Prehabilitation for Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2024-10-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Frail Elderly Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prehabilitation

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

Group Type EXPERIMENTAL

Unsupervised home-based physical prehabilitation

Intervention Type BEHAVIORAL

Subsequent to screening and initial testing for frailty syndrome, participants receive an information booklet containing a selection of exercises, which allows independent prehabilitation at home.

Prehabilitation + TAVI

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.

Group Type EXPERIMENTAL

Unsupervised home-based physical prehabilitation

Intervention Type BEHAVIORAL

Subsequent to screening and initial testing for frailty syndrome, participants receive an information booklet containing a selection of exercises, which allows independent prehabilitation at home.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Control+TAVI

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Unsupervised home-based physical prehabilitation

Subsequent to screening and initial testing for frailty syndrome, participants receive an information booklet containing a selection of exercises, which allows independent prehabilitation at home.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes