NCT03515395

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 6, 2021

Status Verified

May 1, 2019

Enrollment Period

2.7 years

First QC Date

April 19, 2018

Last Update Submit

July 30, 2021

Conditions

Hip FracturesExerciseAging

Keywords

exergaminghip fracturetrainingacceptance

Outcome Measures

Primary Outcomes (1)

  • Acceptance of technology

    Questionnaire based answers about computer game use

    14 days of game use

Secondary Outcomes (1)

  • Functional improvement

    after 14 days of game use

Interventions

Instruction to a computer game and motivation to use itBEHAVIORAL

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.

Eligibility Criteria

Age75 Years - 105 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Patients who were initially admitted from a nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatrische Klinik

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Location

Related Publications (5)

  • Tinetti ME, Williams CS. The effect of falls and fall injuries on functioning in community-dwelling older persons. J Gerontol A Biol Sci Med Sci. 1998 Mar;53(2):M112-9. doi: 10.1093/gerona/53a.2.m112.

    PMID: 9520917BACKGROUND

  • Campbell AJ, Reinken J, Allan BC, Martinez GS. Falls in old age: a study of frequency and related clinical factors. Age Ageing. 1981 Nov;10(4):264-70. doi: 10.1093/ageing/10.4.264.

    PMID: 7337066BACKGROUND

  • Karahan AY, Tok F, Taskin H, Kucuksarac S, Basaran A, Yildirim P. Effects of Exergames on Balance, Functional Mobility, and Quality of Life of Geriatrics Versus Home Exercise Programme: Randomized Controlled Study. Cent Eur J Public Health. 2015 Nov;23 Suppl:S14-8. doi: 10.21101/cejph.a4081.

    PMID: 26849537BACKGROUND

  • van Diest M, Lamoth CJ, Stegenga J, Verkerke GJ, Postema K. Exergaming for balance training of elderly: state of the art and future developments. J Neuroeng Rehabil. 2013 Sep 25;10:101. doi: 10.1186/1743-0003-10-101.

    PMID: 24063521BACKGROUND

  • Chao YY, Scherer YK, Montgomery CA. Effects of using Nintendo Wii exergames in older adults: a review of the literature. J Aging Health. 2015 Apr;27(3):379-402. doi: 10.1177/0898264314551171. Epub 2014 Sep 21.

    PMID: 25245519RESULT

MeSH Terms

Conditions

Hip FracturesMotor Activity

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesBehavior

Study Officials

  • Thomas Münzer, MD

    Geriatrische Klinik St. Gallen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Department of Geriatrics

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 3, 2018

Study Start

August 15, 2018

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

August 6, 2021

Record last verified: 2019-05

Locations

CH(1)