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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03515395
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2019
Information provided by (Responsible Party):
Thomas Munzer, MD, PhD, Geriatrische Klinik St. Gallen

Brief Summary:
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.

Condition or disease Intervention/treatment
Hip Fractures Exercise Aging Behavioral: Instruction to a computer game and motivation to use it

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acceptance and Frequency of Use of a Computer Game Based Exercise Training in Geriatric Patients After Hip Fracture Surgery
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Instruction to a computer game and motivation to use it
    Patients who are willing to use the computer game and who have given written informed consent shall have three instruction sessions by a physiotherapist instructor. They will then asked to use the platform at least 3 times per week at their own discretion. The platform will be installed in the patient room, alternatively in a defined training room. The patient will be free to choose the time and duration of the gaming. This allows the patients to select times that do not interfere with their usual therapy schedule or visits (e.g. evening or weekends). Prior to discharge compliance with the platform will be monitored by analyzing the gaming data of each patient.

Primary Outcome Measures :
  1. Acceptance of technology [ Time Frame: 14 days of game use ]
    Questionnaire based answers about computer game use

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 105 Years   (Older Adult)
Sexes 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)

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

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 identifier (NCT number): NCT03515395

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Contact: Thomas Münzer, MD +41712438880

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Geriatrische Klinik Recruiting
Saint Gallen, SG, Switzerland, 9000
Sponsors and Collaborators
Geriatrische Klinik St. Gallen
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Principal Investigator: Thomas Münzer, MD Geriatrische Klinik St. Gallen
Publications of Results:
Other Publications:
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Responsible Party: Thomas Munzer, MD, PhD, Head Department of Geriatrics, Geriatrische Klinik St. Gallen Identifier: NCT03515395    
Other Study ID Numbers: BASEC 2018-00528
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sharing depends of the quality of the collected data

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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 Thomas Munzer, MD, PhD, Geriatrische Klinik St. Gallen:
hip fracture
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries