Accidental FallsEXCELLNCT01082042
Exercising With Computers in Later Life
An observational study of Accidental Falls and Exercise, run by NHS Grampian at 1 site in United Kingdom.
Trial summary
This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable to a physiotherapist-led falls group in terms of improvement in balance. The acceptability of the Nintendo® Wii will also be assessed. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Accidental Falls, Exercise
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Jun 2009
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Standard Care: The standard care group was recruited from the local falls group that is run from the local Medicine for the Elderly Department. Intevention Group: Participants were recruited following a publicity campaign.
Who may be able to join
- age 70 years or older
- living locally in the community (in either sheltered accommodation or own home
- fallen at least once in the preceding 12 months
- abbreviated mental test (AMT) of seven or over
Who cannot join
- wheelchair bound
- people living in a care home or long-term hospital care.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Medicine for the Elderly, Woodend Hospital
Aberdeen, Aberdeenshire, AB15 6XS
About this study
Official title: Exercising With Computers in Later Life (EXCELL) - Pilot and Feasibility Study of the Nintendo® WiiFit in Community-dwelling Fallers
This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable to a physiotherapist-led falls group in terms of improvement in balance. The acceptability of the Nintendo® Wii will also be assessed.
Read the detailed description
The population is ageing and as a result medical staff and allied health professionals are likely to see an increase in the number of patients with falls. Community dwelling individuals over 65 fall at a rate of 30% per year. This risk increases with advancing age. Falls have significant consequences for both the individual and the population as a whole. Falls risk increases with age due to increased body sway, a reduction in reaction times, deterioration in the efficiency of the walking pattern and diminished balance.
People who fall should be referred for multidisciplinary falls assessment. Locally, patients are assessed by the multidisciplinary team and, if appropriate, attend falls group. This group consists of a 12 week exercise program to improve balance and muscle strength (patients attend the group up to 3 times weekly). Previously trials have shown variable compliance with exercise programs but locally compliance is felt to be good. Falls groups aim to reduce falls through the benefits of exercise; improvement in muscle strength,balance, general fitness and well being. It has been shown that exercise has statistically significant beneficial effects on balance.
Due to advances in technology, equipment has been produced to improve balance on both the medical and commercial market. There is a large variability in cost between this equipment with commercial prices being much lower. The Wii has been very successful in encouraging sedentary youths to partake in exercise (all be it in a limited form). WiiFit is a specifically designed "game" for the Wii to improve balance with an element of entertainment value.
This project is important due the large number of falls that occur in the community and the significant impact this has on an under resourced NHS. It is timely because the WiiFit has only just been introduced into the market. Through the use of a Wii, balance training may be more enjoyable and as a result elderly community dwellers may be more likely to participate in exercise programmes. The Wii is considerably cheaper than the medical alternatives and if an improvement can be shown in post-intervention balance assessments, then we have to consider whether the use of similar equipment should be instituted in falls groups.
- Conditions
- Accidental Falls, Exercise
- Keywords
- Balance, postural, Aged, over 70, Exercise, Accidental falls
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Individuals who attended the local falls group | |
| Intervention group | Individuals who undertook the 12 week exercise (Nintendo WiiFit) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in formal balance score
Berg and Tinetti balance scores
Measured: 4 weeks and 12 weeks following the exercise intervention
Secondary outcomes (2)
Acceptability of the Nintendo WiiFit in community-dwelling older fallers
Individual interview and completion of the Attitudes to Falls-Related Interventions Scale (AFRIS)
Measured: 12 weeks
Participants degree of concern about falling in certain situations following the intervention
Falls Efficacy Scale - International (FES-I)
Measured: 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Collaborators
- British Geriatrics Society
- Investigators
- Marie A Williams, MBChB, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082042
- Sponsor's protocol ID
- BGS05/2008
- Acronym
- EXCELL
- Status last verified
- Jun 2009
- First submitted
- 4 Mar 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.
PubMed 20831836
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercising With Computers in Later Life (EXCELL) - Pilot and Feasibility Study of the Nintendo® WiiFit in Community-dwelling Fallers
- ClinicalTrials.gov ID
- NCT01082042
- Acronym / sponsor ID
- EXCELL / BGS05/2008
- Conditions
- Accidental Falls, Exercise
- Keywords
- Balance, postural, Aged, over 70, Exercise, Accidental falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NHS GrampianOther government
- Collaborators
- British Geriatrics Society
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Mar 2010 (estimated)
- 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.
This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable to a physiotherapist-led falls group in terms of improvement in balance. The acceptability of the Nintendo® Wii will also be assessed.
Detailed description
The population is ageing and as a result medical staff and allied health professionals are likely to see an increase in the number of patients with falls. Community dwelling individuals over 65 fall at a rate of 30% per year. This risk increases with advancing age. Falls have significant consequences for both the individual and the population as a whole. Falls risk increases with age due to increased body sway, a reduction in reaction times, deterioration in the efficiency of the walking pattern and diminished balance.
People who fall should be referred for multidisciplinary falls assessment. Locally, patients are assessed by the multidisciplinary team and, if appropriate, attend falls group. This group consists of a 12 week exercise program to improve balance and muscle strength (patients attend the group up to 3 times weekly). Previously trials have shown variable compliance with exercise programs but locally compliance is felt to be good. Falls groups aim to reduce falls through the benefits of exercise; improvement in muscle strength,balance, general fitness and well being. It has been shown that exercise has statistically significant beneficial effects on balance.
Due to advances in technology, equipment has been produced to improve balance on both the medical and commercial market. There is a large variability in cost between this equipment with commercial prices being much lower. The Wii has been very successful in encouraging sedentary youths to partake in exercise (all be it in a limited form). WiiFit is a specifically designed "game" for the Wii to improve balance with an element of entertainment value.
This project is important due the large number of falls that occur in the community and the significant impact this has on an under resourced NHS. It is timely because the WiiFit has only just been introduced into the market. Through the use of a Wii, balance training may be more enjoyable and as a result elderly community dwellers may be more likely to participate in exercise programmes. The Wii is considerably cheaper than the medical alternatives and if an improvement can be shown in post-intervention balance assessments, then we have to consider whether the use of similar equipment should be instituted in falls groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | – | –Individuals who attended the local falls group |
| Intervention group | – | –Individuals who undertook the 12 week exercise (Nintendo WiiFit) intervention |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Standard Care: The standard care group was recruited from the local falls group that is run from the local Medicine for the Elderly Department. Intevention Group: Participants were recruited following a publicity campaign.
Key inclusion criteria (4 listed)
- age 70 years or older
- living locally in the community (in either sheltered accommodation or own home
- fallen at least once in the preceding 12 months
- abbreviated mental test (AMT) of seven or over
Key exclusion criteria (2 listed)
- wheelchair bound
- people living in a care home or long-term hospital care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in formal balance score
Time frame: 4 weeks and 12 weeks following the exercise intervention
Berg and Tinetti balance scores
2 secondary outcomes
Acceptability of the Nintendo WiiFit in community-dwelling older fallers
Time frame: 12 weeks
Participants degree of concern about falling in certain situations following the intervention
Time frame: 4 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2010.
- Derived from this study: PubMed 20831836Williams MA, Soiza RL, Jenkinson AM, Stewart A. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo(R) WiiFit in community-dwelling fallers. BMC Res Notes. 2010 Sep 13;3:238. doi: 10.1186/1756-0500-3-238.
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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.
Marie A Williams, MBChB principal investigator
NHS Grampian
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 Accidental Falls and Exercise, run by NHS Grampian at 1 site in United Kingdom.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2010. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in formal balance score (time frame: 4 weeks and 12 weeks following the exercise intervention). 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 NCT01082042, which also lists 1 linked publication.
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 5 Mar 2010; AzTrials last refreshed its copy on 28 Oct 2026.