Accidental FallsProfexsNCT02634736
Cluster RCT of Falls Prevention Exergames for Older Adults
A study testing Exergame plus usual treatment in people with Accidental Falls, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This cluster RCT study will investigate the effectiveness of strength/balance Exergames (exercise and computer games that use body movements as controls) developed to improve balance, function, prevent falls and increase exercise adherence for older people in the home setting. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Exergame plus usual treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Sep 2017
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to use gaming technology safely as assessed by the therapist, with access to television and a 2m space in the home to exercise safely (Note: Kinect-based Exergame system does not require the use of any hand-held consoles; and the exercises will be customised/tailored to each participant's needs, including those having difficulty standing a long time);
- participants will be home-dwelling participants aged 60 years and above;
- participants should be able to watch TV with or without glasses from a 2m distance;
- participants should be English-speaking, and registered with primary care general practices; and
- participants must have the mental capacity to give informed consent.
Who cannot join
- currently using gaming technologies to exercise;
- inability to comprehend the study procedures;
- acute illness, severe congestive cardiac failure, uncontrolled hypertension, recent fracture or surgery;
- Myocardial Infarction or Stroke in past 6 months;
- severe cognitive impairment;
- orthopaedic surgery in last 6 months, or on waiting list to have orthopaedic surgery;
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- wheelchair users;
- severe auditory or visual impairment; and
- peripheral neuropathy or other uncontrolled medical conditions likely to compromise the ability to exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Cluster Randomised Controlled Trial Comparing Falls Prevention Exergames With Remote Monitoring Against Standard Falls Prevention Programmes for Community Dwelling Older Adults at Risk of Falls.
This cluster RCT study will investigate the effectiveness of strength/balance Exergames (exercise and computer games that use body movements as controls) developed to improve balance, function, prevent falls and increase exercise adherence for older people in the home setting. The proposal incorporates postural stability Exergames that have been developed with users based on best evidence strength and balance exercise (OTAGO and Postural Stability) currently used by therapists, safe for older people and can be used in the home setting
Read the detailed description
STUDY OBJECTIVES
Primary Question:
To determine the effect of using MIRA falls prevention Exergames to improve balance in older adults.
Secondary Question/Objectives:
- What features of usual falls prevention teams routines/activities need consideration for successful implementation of the strength and balance Exergame intervention?
- How can the Exergames be tailored for home use for older adults?
- What are the most effective outcome measurements to detect meaningful changes resulting from the MIRA Exergame programme?
- What are the current challenges and solutions to accessing robust data depicting costs of current therapy treatment compared to home-based MIRA Exergame treatment?
- Is it possible to retain participants in the intervention during the 12-week MIRA Exergame intervention with respect to outcomes including motivation, enjoyment and usability?
- What training and support needs are required to maximise the use of the MIRA Exergame technology?
- What are the costs of the MIRA Exergame intervention and how cost-effectiveness is the MIRA Exergame intervention compared with usual care.
- What are the effects on falls and fall-related use of health services during a 6-month follow up? STUDY DESIGN \& PROTOCOL Participants This project is a cluster RCT study to test the effectiveness of undertaking MIRA Exergames in the sheltered home setting in addition to usual activities. A maximum of 12 sheltered housing units, with 108 participants will be recruited to participate in the study. These will be split into the experimental group (6 sheltered housing units with n=54) and the control group (6 sheltered housing units with n=54). These 2 groups will be based in 2 falls prevention teams in Manchester and a second site in Glasgow.
Falls prevention team staff and other professionals will also be recruited into the study (n=20) to either give their professional insights and feedback on the usability of the exergames and/or help supervise the participants.
Study Intervention Sheltered Housing facilities will be recruited via the Manchester and Glasgow Housing Associations to enable facilities of similar size and deprivation status to be identified. The sheltered housing facilities will be randomised into two groups: the Exergame/experimental group (n=6 sheltered housing units with 9 participants recruited in each); and the control group (n=6 sheltered housing units with 9 participants recruited in each). The participants in the control groups will be offered the Exergame intervention after the final 12-week measurements for ethical reasons. A pre-enrolment examination will be carried out by a trained research physiotherapist to assess each person's suitability to participate in the Kinect exergame programme, and also evaluate potential impact of the Exergames on various aspects of their physical health. Their GPs will also be notified.
The eligible participants will be given a tailored, individualised [i.e. frequency and duration will be set according to each participant's baseline levels] Exergame programme incorporated into their normal routines plus usual falls prevention treatment (prescribed by the physiotherapists). The control group will be given usual falls prevention assessment, treatment and home exercises without the Exergames. The Exergame intervention will run for 12 weeks to test the efficacy of the intervention. Outcome measures to be used during these 12 weeks will include a series of standardised tests and questionnaires. Each participant will be aided in completing these measures. These assessments will take place 3 times: at baseline, 6 weeks, and at the end of the 12-week period.
The intervention participants will be offered the use the Exergame intervention in a group setting and/or home setting according to their preferences (previously piloted in a small feasibility study). The physiotherapists and physiotherapist assistants will supervise and monitor their progress and will also have the ability to see the results of the Exergame programme (anonymised data on points gained, time used, range of motion) at the Falls Prevention Clinic for participants that consent to the sharing of this anonymised data.
At the end of the 12 weeks, focus groups and interviews will be conducted to assess the therapists and participants' perspectives regarding the effectiveness of the remote MIRA Exergame programmes and their usability.
- Conditions
- Accidental Falls
- Being tested
- Exergame plus usual treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame plus usual treatmentDevice
An individualised [i.e. frequency and duration will be set according to each participant's baseline levels] Exergame programme incorporated into participant's normal routines plus usual falls prevention treatment (prescribed by the physiotherapists).
| Study group | Role | What they receive |
|---|---|---|
| Exergame plus usual treatment | Experimental | Exergame programme plus usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists). Receives: Device: Exergame plus usual treatment |
| Usual treatment | No intervention | No exergame programme, just usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The Berg Balance Scale (BBS)
Measured: 12 weeks
Secondary outcomes (6)
Adherence
Duration in minutes of use of the Exergames
Measured: 12 weeks
Physical activity levels
The Physical Activity Scale for the Elderly to assess user's physical activity levels
Measured: 12 weeks
Lower limb strength
Timed up and go measurement of lower limb strength
Measured: 12 weeks
Fear of falling
The Short Falls Efficacy Scale-International (FES-I) The FES-I is a validated and reliable 7-item tool that measures confidence in performing a range of activities of daily living without falling
Measured: 12 weeks
Cognition
The Addenbrooke's Cognitive Examination III (ACEIII) to measure cognition levels in older adults
Measured: 12 weeks
Mood
The 5-item Geriatric Depression Scale screening tool for depression in older adults
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017
- Study completionSep 2017
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.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Emma Stanmore, University of Manchester
- Investigators
- Emma K Stanmore, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634736
- Sponsor's protocol ID
- R119047/195378
- Acronym
- Profexs
- Status last verified
- Oct 2017
- First submitted
- 9 Dec 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stanmore EK, Mavroeidi A, de Jong LD, Skelton DA, Sutton CJ, Benedetto V, Munford LA, Meekes W, Bell V, Todd C. The effectiveness and cost-effectiveness of strength and balance Exergames to reduce falls risk for people aged 55 years and older in UK assisted living facilities: a multi-centre, cluster randomised controlled trial. BMC Med. 2019 Feb 28;17(1):49. doi: 10.1186/s12916-019-1278-9.
PubMed 30813926
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Cluster Randomised Controlled Trial Comparing Falls Prevention Exergames With Remote Monitoring Against Standard Falls Prevention Programmes for Community Dwelling Older Adults at Risk of Falls.
- ClinicalTrials.gov ID
- NCT02634736
- Acronym / sponsor ID
- Profexs / R119047/195378
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Dec 2015 (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 cluster RCT study will investigate the effectiveness of strength/balance Exergames (exercise and computer games that use body movements as controls) developed to improve balance, function, prevent falls and increase exercise adherence for older people in the home setting. The proposal incorporates postural stability Exergames that have been developed with users based on best evidence strength and balance exercise (OTAGO and Postural Stability) currently used by therapists, safe for older people and can be used in the home setting
Detailed description
STUDY OBJECTIVES
Primary Question:
To determine the effect of using MIRA falls prevention Exergames to improve balance in older adults.
Secondary Question/Objectives:
- What features of usual falls prevention teams routines/activities need consideration for successful implementation of the strength and balance Exergame intervention?
- How can the Exergames be tailored for home use for older adults?
- What are the most effective outcome measurements to detect meaningful changes resulting from the MIRA Exergame programme?
- What are the current challenges and solutions to accessing robust data depicting costs of current therapy treatment compared to home-based MIRA Exergame treatment?
- Is it possible to retain participants in the intervention during the 12-week MIRA Exergame intervention with respect to outcomes including motivation, enjoyment and usability?
- What training and support needs are required to maximise the use of the MIRA Exergame technology?
- What are the costs of the MIRA Exergame intervention and how cost-effectiveness is the MIRA Exergame intervention compared with usual care.
- What are the effects on falls and fall-related use of health services during a 6-month follow up? STUDY DESIGN \& PROTOCOL Participants This project is a cluster RCT study to test the effectiveness of undertaking MIRA Exergames in the sheltered home setting in addition to usual activities. A maximum of 12 sheltered housing units, with 108 participants will be recruited to participate in the study. These will be split into the experimental group (6 sheltered housing units with n=54) and the control group (6 sheltered housing units with n=54). These 2 groups will be based in 2 falls prevention teams in Manchester and a second site in Glasgow.
Falls prevention team staff and other professionals will also be recruited into the study (n=20) to either give their professional insights and feedback on the usability of the exergames and/or help supervise the participants.
Study Intervention Sheltered Housing facilities will be recruited via the Manchester and Glasgow Housing Associations to enable facilities of similar size and deprivation status to be identified. The sheltered housing facilities will be randomised into two groups: the Exergame/experimental group (n=6 sheltered housing units with 9 participants recruited in each); and the control group (n=6 sheltered housing units with 9 participants recruited in each). The participants in the control groups will be offered the Exergame intervention after the final 12-week measurements for ethical reasons. A pre-enrolment examination will be carried out by a trained research physiotherapist to assess each person's suitability to participate in the Kinect exergame programme, and also evaluate potential impact of the Exergames on various aspects of their physical health. Their GPs will also be notified.
The eligible participants will be given a tailored, individualised [i.e. frequency and duration will be set according to each participant's baseline levels] Exergame programme incorporated into their normal routines plus usual falls prevention treatment (prescribed by the physiotherapists). The control group will be given usual falls prevention assessment, treatment and home exercises without the Exergames. The Exergame intervention will run for 12 weeks to test the efficacy of the intervention. Outcome measures to be used during these 12 weeks will include a series of standardised tests and questionnaires. Each participant will be aided in completing these measures. These assessments will take place 3 times: at baseline, 6 weeks, and at the end of the 12-week period.
The intervention participants will be offered the use the Exergame intervention in a group setting and/or home setting according to their preferences (previously piloted in a small feasibility study). The physiotherapists and physiotherapist assistants will supervise and monitor their progress and will also have the ability to see the results of the Exergame programme (anonymised data on points gained, time used, range of motion) at the Falls Prevention Clinic for participants that consent to the sharing of this anonymised data.
At the end of the 12 weeks, focus groups and interviews will be conducted to assess the therapists and participants' perspectives regarding the effectiveness of the remote MIRA Exergame programmes and their usability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame plus usual treatment | Experimental | Device: Exergame plus usual treatmentExergame programme plus usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists). |
| Usual treatment | No intervention | –No exergame programme, just usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- able to use gaming technology safely as assessed by the therapist, with access to television and a 2m space in the home to exercise safely (Note: Kinect-based Exergame system does not require the use of any hand-held consoles; and the exercises will be customised/tailored to each participant's needs, including those having difficulty standing a long time);
- participants will be home-dwelling participants aged 60 years and above;
- participants should be able to watch TV with or without glasses from a 2m distance;
- participants should be English-speaking, and registered with primary care general practices; and
- participants must have the mental capacity to give informed consent.
Key exclusion criteria (9 listed)
- currently using gaming technologies to exercise;
- inability to comprehend the study procedures;
- acute illness, severe congestive cardiac failure, uncontrolled hypertension, recent fracture or surgery;
- Myocardial Infarction or Stroke in past 6 months;
- severe cognitive impairment;
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 |
|---|---|---|
| Exergame plus usual treatmentAn individualised [i.e. frequency and duration will be set according to each participant's baseline levels] Exergame programme incorporated into participant's normal routines plus usual falls prevention treatment (prescribed by the physiotherapists). | Device | Exergame plus usual treatment |
Primary outcome
Balance
Time frame: 12 weeks
The Berg Balance Scale (BBS)
6 secondary outcomes
Adherence
Time frame: 12 weeks
Physical activity levels
Time frame: 12 weeks
Lower limb strength
Time frame: 12 weeks
Fear of falling
Time frame: 12 weeks
Cognition
Time frame: 12 weeks
Mood
Time frame: 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 26 Oct 2017.
- Derived from this study: PubMed 30813926Stanmore EK, Mavroeidi A, de Jong LD, Skelton DA, Sutton CJ, Benedetto V, Munford LA, Meekes W, Bell V, Todd C. The effectiveness and cost-effectiveness of strength and balance Exergames to reduce falls risk for people aged 55 years and older in UK assisted living facilities: a multi-centre, cluster randomised controlled trial. BMC Med. 2019 Feb 28;17(1):49. doi: 10.1186/s12916-019-1278-9.
- Individual participant dataSharing planned: No
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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.
Emma K Stanmore, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame plus usual treatment in people with Accidental Falls, run by University of Manchester 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 5 inclusion and 9 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 26 Oct 2017. 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?
Balance (time frame: 12 weeks). 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 NCT02634736, 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 26 Oct 2017.