Hip FracturesENTERAIN-HFNCT03515395
Entertainement and Training After a Hip Fracture
An observational study of Hip Fractures and Exercise, run by Geriatrische Klinik St. Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 105 years
- Conditions the study is for
- Hip Fractures, Exercise, Aging
- What is being tested?
- Instruction to a computer game and motivation to use it
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Aug 2018to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 105 years
- All sexes
- Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geriatrische Klinik
Sankt Gallen, Canton of St. Gallen, 9000
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fractures, Exercise, Aging
- Being tested
- Instruction to a computer game and motivation to use it
- Keywords
- exergaming, hip fracture, training, acceptance
- Medical subject headings
- Hip Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instruction to a computer game and motivation to use itBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of technology
Questionnaire based answers about computer game use
Measured: 14 days of game use
Secondary outcomes (1)
Functional improvement
Measurement of mobility (short physical performance battery test) score hand grip strength in both hands (kPa) the best of three trials will be recorded
Measured: after 14 days of game use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start15 Aug 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Why it stopped: Low recruitement, no scientific staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geriatrische Klinik St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Munzer, MD, PhD, Geriatrische Klinik St. Gallen
- Investigators
- Thomas Münzer, MD, Principal investigator, Geriatrische Klinik St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515395
- Sponsor's protocol ID
- BASEC 2018-00528
- Acronym
- ENTERAIN-HF
- Status last verified
- May 2019
- First submitted
- 19 Apr 2018
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing depends of the quality of the collected data
Publications
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.
PubMed 9520917Campbell 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.
PubMed 7337066Karahan 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.
PubMed 26849537van 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.
PubMed 24063521Chao 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.
PubMed 25245519
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Frequency of Use of a Computer Game Based Exercise Training in Geriatric Patients After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT03515395
- Acronym / sponsor ID
- ENTERAIN-HF / BASEC 2018-00528
- Conditions
- Hip Fractures, Exercise, Aging
- Keywords
- exergaming, hip fracture, training, acceptance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low recruitement, no scientific staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geriatrische Klinik St. GallenUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 to 105 years
- Sex
- All
- Age groups
- Older adult
- 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)
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instruction to a computer game and motivation to use itPatients 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. | Behavioural | – |
Primary outcome
Acceptance of technology
Time frame: 14 days of game use
Questionnaire based answers about computer game use
1 secondary outcome
Functional improvement
Time frame: after 14 days of game use
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Background: PubMed 9520917Tinetti 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.
- Background: PubMed 7337066Campbell 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.
- Background: PubMed 26849537Karahan 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.
- Background: PubMed 24063521van 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.
- Results publication: PubMed 25245519Chao 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.
- Individual participant dataSharing planned: Undecided. Sharing depends of the quality of the collected data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Münzer, MD principal investigator
Geriatrische Klinik St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Exercise, run by Geriatrische Klinik St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of technology (time frame: 14 days of game use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515395, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.