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.
Condition or disease | Intervention/treatment | Phase |
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Frail Elderly Syndrome | Behavioral: Unsupervised home-based physical prehabilitation | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 644 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
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. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Pre-operative Physical Training for Elderly Patients With Frailty |
Actual Study Start Date : | May 29, 2019 |
Estimated Primary Completion Date : | April 1, 2022 |
Estimated Study Completion Date : | October 1, 2022 |
Arm | Intervention/treatment |
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Experimental: Prehabilitation
Participants are scheduled for elective surgery and follow the home-based prehabilitation for 11-17 days
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Behavioral: 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.
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Experimental: 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.
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Behavioral: 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.
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No Intervention: 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.
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No Intervention: 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.
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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cynthia Olotu, MD | +49407410 ext 52415 | c.olotu@uke.de | |
Contact: Cordelia Julia Hempel, MD | +49407410 ext 52415 | j.hempel@uke.de |
Germany | |
Rotkreuzklinikium München | Not yet recruiting |
München, Bayern, Germany, 80634 | |
University Medical Center Eppendorf | Recruiting |
Hamburg, Germany, 20247 | |
Contact: Cynthia Olotu, MD +49407410 ext 52415 c.olotu@uke.de | |
Agaplesion Diakonieklinikum Hamburg | Recruiting |
Hamburg, Germany, 20259 |
Principal Investigator: | Cynthia Olotu, MD | Department of Anaesthesiology, University Medical Center Eppendorf |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 28, 2019 | ||||||||
First Posted Date ICMJE | May 28, 2019 | ||||||||
Last Update Posted Date | July 16, 2019 | ||||||||
Actual Study Start Date ICMJE | May 29, 2019 | ||||||||
Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Quality of recovery: QoR-15 [ Time Frame: 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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Home-based Prehabilitation for Elderly Patients | ||||||||
Official Title ICMJE | Pre-operative Physical Training for Elderly Patients With Frailty | ||||||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment 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. Masking: None (Open Label)Primary Purpose: Prevention |
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Condition ICMJE | Frail Elderly Syndrome | ||||||||
Intervention ICMJE | Behavioral: 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.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
644 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | October 1, 2022 | ||||||||
Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years and older (Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Germany | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03964363 | ||||||||
Other Study ID Numbers ICMJE | PV5951 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Universitätsklinikum Hamburg-Eppendorf | ||||||||
Study Sponsor ICMJE | Universitätsklinikum Hamburg-Eppendorf | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Universitätsklinikum Hamburg-Eppendorf | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |