Home-based Prehabilitation for Elderly Patients (TRAilty)

July 21, 2026 updated by: Universitätsklinikum Hamburg-Eppendorf

Pre-operative Physical Training for Elderly Patients With Frailty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

512

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 80634
        • Rotkreuzklinikium München
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20247
        • University Medical Center Eppendorf
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20259
        • Agaplesion Diakonieklinikum Hamburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months postoperative
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.
preoperative, 3 months postoperative
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
preoperative, 7 days and 3 months postoperative
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.
preoperative, 3 months postoperative
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.
preoperative, 7 days postoperative
Incidence of postoperative complications
Time Frame: preoperative, 7 days and 3 months postoperative
Complications reported in hospital files or patient interview
preoperative, 7 days and 3 months postoperative
Duration of hospital admission
Time Frame: 3 months postoperative
Day of admission to day of discharge
3 months postoperative
Cognitive performance
Time Frame: preoperative, 7 days and 3 months postoperative
Cognitive functioning 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.
preoperative, 7 days and 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Cynthia Olotu, MD, Department of Anaesthesiology, University Medical Center Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV5951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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