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Completed

NCT Number: NCT04418271

Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)

The aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome "care dependency" one year after surgery. The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial.

The objective of PRÄP-GO is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabetes Zentrum, Bad Oeynhausen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Study patients:

Inclusion criteria

  • Age ≥ 70 years
  • Consent by Patient or Legal Representative
  • Elective surgery planned
  • Expected anesthesia duration≥ 60 min
  • Statutory health insurance
  • Frailty syndrome (≥1 positive out of 5 standardized parameters according to the Physical Frailty Phenotype according to Fried et. al.)

Exclusion criteria

  • Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
  • Intracranial interventions
  • Moribund patients (palliative situation)
  • Not enough language skills
  • Participation in another interventional rehabilitation study or other interventional clinical trial that has not been approved by the study management committee (Exception: Participation in adjuvant intervention study)

Treatment and study plan

Prehabilitation- new form of care

Behavioral

The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.

Primary outcomes

  1. Degree of care dependency

    Time frame: Up to one year

    Assessment results in a degree of care dependency from personal help according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008). The results of the assessments ranges between 0 and 100 points, which are transformed into a 0-5 ordinal scale. Higher points in the assessments indicate higher demand of care dependency. Accordingly, higher numbers on the ordinal scale indicate a higher level of care dependency as defined in the German statutory care insurance program.

Secondary outcomes

  1. Barthel Index

    Time frame: Up to one year

    Level of care dependency after surgery reported as Barthel Index

  2. Change in NBA score

    Time frame: Up to one year

    Assessment results according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008) using the results of the assessments on the scale from 0 to 100 points

  3. NBA domain change

    Time frame: Up to one year

    Change in individual domains of the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)).

  4. Surrogate for Neurocognitive Disorder (NCD)

    Time frame: Up to one year

    Frequency of neurocognitive vulnerability at 3 or 12 months as surrogate for NCD is measured as composite score:

    • Frequency of cognitive impairment/vulnerability is calculated from a change in composite of MiniCog, ANT, TMT-B and MOCA
    • subjective concern (MMQ) and
    • IADL/ADL
  5. Screening tool for cognitive vulnerability

    Time frame: Up to one year

    Cognitive vulnerability is suspected by limited MiniCog-test result. The MiniCog consists of two items, the word recall test and the clock-drawing test. Performance in these test is rated on a scale ranging from 0 - 5, with <3 points indicating a cognitive vulnerability.

  6. Dementia risk assessed by MOCA

    Time frame: Up to one year

    Dementia risk is assessed by Montreal Cognitive Assessment (MOCA-30) deterioration (change) and its absolute value if < 26.

  7. Delirium

    Time frame: Up to one year

    Delirium as perioperative complication assessed until hospital discharge using billing data.

  8. Frailty

    Time frame: Up to one year

    Frailty is operationalized using modified Fried frailty criteria. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status.

  9. Perioperative complications by Clavien-Dindo

    Time frame: Up to hospital discharge

    Perioperative complications assessed using Clavien Dindo till hospital discharge

  10. Every mobility

    Time frame: Up to one year

    Level of everyday mobility using Life-Space Assessment (LSA)

  11. Autonomy Preference

    Time frame: At the beginning of the observation

    Extent of patients' autonomy preference concerning medical decisions; Autonomy-Preference-Index, modified German version (API-Dm). The scale consists of a 11-item questionnaire with 4 questions on preferred autonomy in health-related decisions and 7 items on information preference. The total results of the API and both subscales are transformed into a 0 - 100 scale with higher values indicating higher levels on autonomy and information preference, respectively.

  12. Extent of involvement in shared decision-making process

    Time frame: At the beginning of the observation

    Extent of patients, relatives and health professionals' involvement in shared decision-making process; 9-Item Shared Decision Making Questionnaire (SDM-Q-9/SDM-Q-Doc)

  13. Arm circumference

    Time frame: Up to one year

    Arm circumference is measured in a standardized position and documented in centimeter.

  14. Calf circumference

    Time frame: Up to one year

    Calf circumference is measured in a standardized position and documented in centimeter.

  15. Nutritional Status

    Time frame: Up to one year

    Changes of nutritional status after elective surgery.

  16. Change in body weight

    Time frame: Up to one year

    Changes in body weight measured in kg.

  17. Instrumental Activities of daily living (IADL)

    Time frame: Up to one year

    Instrumental Activities of daily living (IADL) using the questionnaire by Lawton and Brody.

  18. Functional endurance

    Time frame: Up to one year

    Functional endurance is measured using the 2-Minute-Step-Test (2-MST). The patient steps in place, raising each leg to a marker. The markers height is derived from biometrical measures of the patient. The assessor counts each step of the right leg in which the knee of the patient passes the marker. Higher counts of steps indicates better functional endurance.

  19. Function of the respiratory system

    Time frame: Up to one year

    The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.

  20. Depression

    Time frame: Up to one year

    Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]

  21. Anxiety

    Time frame: Up to one year

    Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)

  22. Health related quality of life

    Time frame: Up to one year

    Health related quality of life is measured with EQ-5D-5L questionnaire.

  23. Disability by WHODAS 2.0

    Time frame: Up to one year

    Patient- or proxy-reported functioning and disability is measured by the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version.

  24. Falls

    Time frame: Up to one year

    Incidence of falls

  25. Fear of Falling

    Time frame: Up to one year

    Activities-Specific Balance Confidence (ABC)-6-Scale. The scale consists of 6 questions who are rated on a 0-100 NRS-scale. The total result of the ABC-6-scale comprises of the average of all 6 items.

  26. Satisfaction with the intervention: ZUF-8

    Time frame: Up to one year

    The satisfaction of the patient is measured with the questionnaire on patient satisfaction (ZUF-8). The ZUF-8 is a questionnaire on patient satisfaction after treatment. It consists of 8 questions which results in a score between 0 and 24 points, with higher values.indicating higher levels of satisfaction.

  27. Mortality

    Time frame: Up to one year

    Data from patient records and residents' registration

  28. Muscle strength

    Time frame: Up to one year

    Muscle strength measured by handgrip strength

  29. Functional mobility

    Time frame: Up to one year

    Functional mobility is measured with gait speed over 15ft

  30. Stair climbing speed

    Time frame: Up to one year

    Stair climbing speed test

  31. Timed Up & Go Test (TUG

    Time frame: Up to one year

    Timed Up & Go Test (TUG) to test mobility and body balance

  32. Postoperative functional mobility

    Time frame: Up to one year

    Postoperative complication of mobilization speed measured with CHARMI

  33. Length of stay Intensive Care Unit

    Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]

    Intensive care unit length of stay describes every day spent in an ICU bed.

  34. Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)

    Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]

    Admission rate (planned / unplanned) on ICU

  35. Duration of hospital stay

    Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]

    Time in hospital

Other outcomes

  1. Adverse Discharge Disposition

    Time frame: Participants are followed up after hospital discharge for 1 day

    Adverse discharge disposition other than to home and planned rehabilitation facility.

  2. Necessity for follow-up treatment and rehabilitation

    Time frame: Up to one year

    Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.

  3. Count of new discharge diagnoses

    Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]

    New medical diagnoses at hospital discharge compared to baseline are assessed.

  4. Count of new discharge medication

    Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]

    New medication at hospital discharge compared to baseline is assessed.

  5. Duration of rehabilitation

    Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 25 days]

    Patient record data, discharge letter

  6. Health economic benefit

    Time frame: Up to one year

    ScreeningThe health economic benefit of the intervention (prehabilitation) will be compared to standard of care in the German health care system using a health cost analysis framework.

  7. Exercise adherence and planned prehabilitation composition

    Time frame: Up to one year

    Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.

  8. Patient support

    Time frame: Up to one year

    Patient support by need/prescription of assistive devices ("Hilfsmittel") and therapeutic treatment ("Heilmittel").

  9. Polypharmacy

    Time frame: Up to one year

    Measured by number of drug agents

  10. Alcohol Use

    Time frame: Up to one year

    Measured by Alcohol Use Disorders Identification Test (AUDIT-C)

  11. Tobacco Use

    Time frame: Up to one year

    Measured by Fagerstrom (Fagerstrom & Schneider, 1989)

  12. Sarcopenia

    Time frame: Up to one year

    Sarcopenia is evaluated as a composite measure by three criteria that are assessed: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference) and 3) low physical performance (gait speed or TUG).

  13. Social situation measurement 1

    Time frame: Up to one year

    The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).

  14. Social situation measurement 2

    Time frame: Up to one year

    The social situation 2 of the patient is measured by BSSS, 8-items

  15. Pain: Numeric rating scale

    Time frame: Up to one year

    Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.

  16. Loneliness

    Time frame: Up to one year

    Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • BARMER
  • Ludwig-Maximilians - University of Munich
  • Technische Universität Berlin

Registry information

Official study title

Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2020
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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