Entertainement and Training After a Hip Fracture (ENTERAIN-HF)

July 30, 2021 updated by: Thomas Munzer, MD, PhD, Geriatrische Klinik St. Gallen

Acceptance and Frequency of Use of a Computer Game Based Exercise Training in Geriatric Patients After Hip Fracture Surgery

Older persons are at riskt for falls and fractures. After hip surgery they are normally treated with physical or occupational therapy. The additional use of computer based exercise games for training and the acceptance of such a technology are unclear. Thus, we plant to assess the above outcome ins an observational pilot study.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Falls and fall-associated fractures have a big medical burden on our societies. Older persons who suffer from a fall that leads to a trauma and fracture often loose functional capacity. They may have prolonged mobility problems and are at risk for long-term care or nursing home institutionalization. To date, measures to prevent such negative outcomes are early mobilization and functional physical or occupational therapy immediately following orthopedic surgery. In addition, patients usually are asked to train at home after hospital discharge. This can be achieved by a home training program or by ambulatory physical therapy. Recent technological development has introduced computerized training and gaming platforms into geriatric rehabilitation settings and home exercise training. Games that have been developed for a younger population have now been adapted to the needs of older persons. A recent systematic review has demonstrated that such platforms. for example Wii significantly improve balance and therefore have the potential to prevent falls]. However to date such platforms have not been evaluated in a defined geriatric hospital patient population (e.g. after a hip fracture) as an adjunct to in-hospital physical therapy. Thus, such platforms could be offered as an additional training opportunity.

Study Type

Observational

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

  • Switzerland
    • SG
      • Saint Gallen, SG, Switzerland, 9000
        • Geriatrische Klinik

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

75 years to 105 years (OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients age 75 and older who sufferd from a trauma leading to a hip fracture Surgical procedure: intramedullary gamma nail osteosynthesis (IGNOS, gamma nail)

Description

Inclusion Criteria:

Living at home or in a retirement home (independent living situation) Time between surgery and the start of the gaming intervention less or equal 10 days Patient must be able to ambulate and to have full weight bearing

Exclusion Criteria:

The following exclusion criteria will apply

  • Acute delirium (daily delirium observation score > 3 during the first three consecutive days) lasting for more than 10 days. If the delirium resolves within the 10 day period (see above) patients without cognitive decline are still eligible.
  • A history of severe dementia prior to admission or poor cognition at admission after exclusion of delirium (MOCA score < 15 or MMT < 15).
  • Patients who were initially admitted from a nursing home

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of technology
Time Frame: 14 days of game use
Questionnaire based answers about computer game use
14 days of game use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional improvement
Time Frame: after 14 days of game use
Measurement of mobility (short physical performance battery test) score hand grip strength in both hands (kPa) the best of three trials will be recorded
after 14 days of game use

Collaborators and Investigators

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

Sponsor

Geriatrische Klinik St. Gallen

Investigators

  • Principal Investigator: Thomas Münzer, MD, Geriatrische Klinik St. Gallen

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)

August 15, 2018

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (ACTUAL)

May 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC 2018-00528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Sharing depends of the quality of the collected data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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