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Home-based Prehabilitation for Elderly Patients (TRAilty)

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ClinicalTrials.gov Identifier: NCT03964363
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Behavioral: Unsupervised home-based physical prehabilitation Not Applicable

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

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.
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.

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.
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Quality of recovery: QoR-15 [ Time Frame: 3 months 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)

  2. Health related quality of life: Questionnaire Short Form-12 (SF-12) [ Time Frame: preoperative, 3 months postoperative ]
    The World Health Organisation Disability Assessment Schedule (WHODAS) assesses six domains of functioning relating to the quality of life. Quality of life is measured using the Questionnaire Short Form-12 (SF-12), which indicates physical and psychological wellbeing. Higher scores indicate a better health related quality of life.

  3. Activities of daily living [ Time Frame: preoperative, 7 days and 3 months postoperative ]
    The Lawton-Brody Instrumental Activities of Daily Living is used to assess the ability to perform activities that are central to living independently. A lower score indicates better functioning. The score ranges between 8 - 31

  4. Cognitive performance [ Time Frame: preoperative, 7 days and 3 months postoperative ]
    Cognitive funtioning will be tested with the Montreal Cognitive assessment (MOCA), a standardised test that includes memory recall, verbal fluency and visuospatial abilities. A total score between 0 and 30 is calculated with a higher score indicating better cognitive functioning.

  5. Mobility [ Time Frame: preoperative, 3 months postoperative ]
    The time up&go-test, in which the subject starts from a sitting position, walks a defined distance of 3 m and returns to a sitting position on a chair is indicative of fall risk and mobility. The chosen cut-off in this study is 10 seconds.

  6. Muscle strength [ Time Frame: preoperative, 7 days postoperative ]
    Grip strength is widely used in the diagnosis of frailty and sarcopenia. It will be measured with a hand held dynamometer in kg, using the dominant hand if possible.

  7. Incidence of postoperative complications [ Time Frame: preoperative, 7 days and 3 months postoperative ]
    Complications reported in hospital files or patient interview

  8. Duration of hospital admission [ Time Frame: 3 months postoperative ]
    Day of admission to day of discharge



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pre-frail or frail according to (Longitudinale Urbane Cohorten Altersstudie) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964363


Contacts
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Contact: Cynthia Olotu, MD +49407410 ext 52415 c.olotu@uke.de
Contact: Cordelia Julia Hempel, MD +49407410 ext 52415 j.hempel@uke.de

Locations
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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
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Cynthia Olotu, MD Department of Anaesthesiology, University Medical Center Eppendorf

Publications:

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03964363     History of Changes
Other Study ID Numbers: PV5951
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
elderly
Frailty
preoperative period
surgery
breathing exercise
postoperative complications
resistance training
endurance training
anaesthesia
activities of daily living
patient reported outcome
prehabilitation
perioperative care
prevention