Administrative information
Title {1} | Prehabilitation in older patients prior to elective cardiac procedure (PRECOVERY): study protocol for a randomized, controlled, longitudinal, multicenter, two-arm, assessor-blinded trial |
Trial registration {2a and 2b} | German Clinical Trials Register (DRKS; http://www.drks.de) (DRKS00030526) |
Protocol version {3} | V3.0 from 27th of March 2023 |
Funding {4} | Grant 01NVF21109 of the “Innovationsausschuss” of the German Federal Joint Committee (G-BA) |
Author details {5a} | Carolin Steinmetz, PhD1†, Stephanie Heinemann, PhD1†, Ingo Kutschka, MD2,3, Gerd Hasenfuß, MD3,4, Thomas Asendorf, PhD5, Bjoern Andrew Remppis, MD6, Ernst Knoglinger, MD7, Clemens Grefe, MD8, Johannes Maximilian Albes, MD9, Hassina Baraki, MD2,3, Christian Baumbach, MD6, Susanne Brunner, MD10, Susann Ernst, MD11, Wolfgang Harringer, MD12, Dirk Heider, PhD13, Daniela Heidkamp, MD14, Christoph Herrmann-Lingen, MD3,15, Eva Hummers, MD16, Thomas Kocar, MD17, Hans-Helmut König, PhD13, Simone Krieger PhD15, Andreas Liebold, MD18, Andreas Martens, MD19, Marcus Matzeder20, Friedrich Mellert, MD21, Christiane Müller, MD16, Miriam Puls, MD3,4, Nils Reiss, MD22, Martin Schikora, MD23, Thomas Schmidt, PhD24, Martin Vestweber25, Monika Sadlonova, MD1,2,3,15†, Christine A.F. von Arnim1,3†* and other associated PRECOVERY investigators as well as PRECOVERY investigators 1Department of Geriatrics, University of Goettingen Medical Center, Goettingen, Germany 2Department of Cardiovascular and Thoracic Surgery, University of Goettingen Medical Center, Goettingen, Germany 3German Center for Cardiovascular Research (DZHK), partner site Goettingen, Goettingen, Germany 4Department of Cardiology and Pneumology, University of Goettingen Medical Center, Goettingen, Germany 5Department of Medical Statistics, University of Goettingen Medical Center, Goettingen, Germany 6Heart and Vascular Center Bad Bevensen, Bad Bevensen, Germany 7Kirchberg Clinic, Bad Lauterberg, Bad Lauterberg, Germany 8Clinic and Rehabilitation Center Lippoldsberg, Wesertal, Germany 9Immanuel Clinic Bernau, Brandenburg Heart Center, Bernau, Germany 10Clinic Fallingbostel, Bad Fallingbostel, Germany 11ZAR Center for Outpatient Rehabilitation GmbH, Ulm, Germany 12Department of Cardiac, Thoracic and Vascular Surgery, Braunschweig Municipal Hospital, Braunschweig, Germany 13Department of Health Economics & Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany 14Rehabilitation Center Oldenburg, Oldenburg, Germany 15Department of Psychosomatic Medicine and Psychotherapy, University of Goettingen Medical Center, Goettingen, Germany 16Department of General Practice, University of Goettingen Medical Center, Goettingen, Germany 17Geriatric Center Ulm, Ulm, Germany 18Department for Thoracic, Cardiac and Vascular Surgery, Ulm University Medical Center, Ulm, Germany 19Department of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany 20AOK Health Insurance (AOK Lower Saxony) 21Department of Cardiac Surgery, Oldenburg Hospital, Oldenburg, Germany 22Schüchtermann-Schiller'sche Clinic, Bad Rothenfelde, Germany 23Brandenburg Clinic, Bernau Waldsiedlung, Germany 24Institute of Cardiology and Sports Medicine, Department Preventive and Rehabilitative Sport and Exercise Medicine, German Sport University, Cologne, Germany 25German Heart Foundation, Frankfurt am Main, German |
Name and contact information for the trial sponsor {5b} | Innovationsausschuss beim Gemeinsamen Bundesausschuss (G-BA); Gutenbergstraße 13, 10,587 Berlin; Postfach 12 06 06, 10,596 Berlin; Email: info@if.g-ba.de The German Federal Joint Committee is a legal entity under public law Authorized representative: Prof. Josef Hecken; Competent supervisory authority: German Federal Ministry of Health |
Role of sponsor {5c} | G-BA is a public sponsor in Germany. The G-BA had no role in the study design; collection, management, analysis, interpretation, or reporting of the data; report preparation; or publication decisions |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
OPS Code and Procedure |
---|
5–35: Operations on heart valves and septa as well as on vessels close to the heart |
5–351: Replacement of heart valves with prostheses |
5–352: Change of heart valve prostheses |
5–353: Valvuloplasty |
5–354: Other operations on heart valves |
5-35a: Minimally invasive surgery on heart valves |
5–36: Coronary artery surgery |
5–360: Desobliteration (endarterectomy) of coronary arteries |
5–361: Creating an aortocoronary bypass |
5–362: Creating an aortocoronary bypass using minimally invasive technique |
5–363: Other revascularization of the heart |
Inclusion criteria |
Age ≥ 75 years |
Planned elective cardiac procedure (OPS: 5–351 to 354, 5-35a, 5–360 to 363) |
Sufficient independence, ability to care for self and participate in prehabilitation |
Insurance status of all patients from Lower Saxony to patients of AOK (public health insurance provider) |
Ability to give consent |
Willingness to participate voluntarily in the study after informed consent with signed consent form |
Ability to speak, read, and understand German |
Exclusion criteria |
Lack of capacity to consent |
Katz index 0 |
Need for treatment in an acute care hospital |
Severe dementia or severe mental disorders, acute delirium |
Diagnosis of acute alcohol or drug abuse |
Unstable angina pectoris |
Heart failure, NYHA IV |
Myocarditis, hypertrophic obstructive cardiomyopathy, main stem stenosis ≥ 80% |
Severe refractory cardiac arrhythmias |
Recent aortic dissection |
Peripheral arterial occlusive disease stage ≥ III according to Fontaine |
Symptomatic carotid stenosis or carotid stenosis requiring therapy |
Renal insufficiency requiring dialysis |
Hepatic insufficiency, child B and child C |
Advanced (metastasized) oncological disease |
Neurological, orthopedic or rheumatic comorbidities that militate against physical training |
Participation in another intervention study (participation in registry studies is allowed) |
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Prehabilitation
Form of therapy | Minimum of requirements |
---|---|
(1) Sports and exercise therapy | Scope: 1 active unit per day (5 × per week) of 30 min each |
Content: endurance, strength/flexibility, coordination training | |
(2) Breathing therapy | Scope: 3 times per week of 30 min each |
Content: Group setting with daily self-training | |
(3) Occupational therapy | Scope: 2 times per week of 30 min each |
Content: see exercise therapy plus tips for the sustainability of prehabilitation | |
(4) Cognitive training | Scope: 2 times per week of 30 min each |
Content: attention and concentration training | |
(5) Psychosocial intervention | Scope: 2 times during prehabilitation period |
Content: Delirium education, preparation for surgery inclusive procedures in the hospital and PMR | |
(6) Disease-specific education | Scope: 3 units in the prehabilitation period, video training if necessary |
Content: sleep, nutrition, exercise, risk factors, mindfulness, social counseling | |
(7) Informative talks with relatives | Scope: 1 time during the prehabilitation period |
Content: see treatment manual in the additional file 3 |
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Time point | t0 (Screening) | t1 (Randomization/ Baseline) | t2 (Before CP) | t3 (After CP) | t4 (30 days after CP) | t5 (6 months after CP) | T6 (12 months after CP) |
---|---|---|---|---|---|---|---|
Inclusion/Exclusion criteria | x | ||||||
Informed consent, enrollment, allocation | x | ||||||
Medical history, social demographics | x | ||||||
Primary Outcomes | |||||||
EQ-5D-5L (QoL) | x | x | x | x | x | x | |
1-year mortality | x | ||||||
Secondary Outcomes | |||||||
Katz Index (daily activity) | x | x | x | x | x | x | |
SPPB (physical performance) | x | x | x | ||||
MoCa (mental performance) | x | x | x | ||||
HeartQoL (disease-specific QoL) | x | x | x | x | x | ||
HADS (anxiety and depression) | x | x | x | x | x | ||
Other Outcomes | |||||||
30-day mortality | x | ||||||
Hand grip strength (frailty) | x | x | x | ||||
6-min walk test (functional capacity) | x | x | x | ||||
BIA (body composition) | x | x | x | ||||
MNA (frailty, malnutrition) | x | x | x | ||||
PSQI (sleep quality) | x | x | x | ||||
Maastricht questionnaire (vital exhaustion) | x | x | x | x | |||
UCLA Loneliness Scale (loneliness) | x | x | x | ||||
SMI (memory impairment) | x | x | x | x | x | ||
CFS (frailty) | x | x | x | x | |||
Pre- and post-procedure complications | x | ||||||
Length of stay in intensive and normal care | x | ||||||
Institutionalization/dependence on care | x | x | x | x | x | x | |
ATS scale (dyspnea) | x | x | x | x | x | x | |
SWE scale (general self-efficacy) | x | x | x | x | |||
HFK (patients ‘ satisfaction with hospital stay) | x | ||||||
LOT-R (optimism) | x | x | |||||
IPQ-B (illness perception) | x | x | x | ||||
TEX-Q (treatment expectancy) | x | x | |||||
Process evaluation | x | x | x | x | x | x | |
FIMA Questionnaire (healthcare-related resource utilization) | x | x | x | ||||
Blood sample | x | x | x | x | |||
AE/SAE | x | x | x | x | x | ||
Relatives: G-ZBI (burden of relatives) | x | x | x | ||||
Relatives: IQCODE (opinion of relatives) | x | x | x |