- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02634736
Cluster RCT of Falls Prevention Exergames for Older Adults (Profexs)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lancashire
-
Manchester, Lancashire, United Kingdom, M13 9PL
- Dr Emma Stanmore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion criteria for recruiting participants:
- 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.
Exclusion Criteria:
- 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;
- wheelchair users;
- severe auditory or visual impairment; and
- peripheral neuropathy or other uncontrolled medical conditions likely to compromise the ability to exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exergame plus usual treatment
Exergame programme plus usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists).
|
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).
|
No Intervention: Usual treatment
No exergame programme, just usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: 12 weeks
|
The Berg Balance Scale (BBS)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: 12 weeks
|
Duration in minutes of use of the Exergames
|
12 weeks
|
Physical activity levels
Time Frame: 12 weeks
|
The Physical Activity Scale for the Elderly to assess user's physical activity levels
|
12 weeks
|
Lower limb strength
Time Frame: 12 weeks
|
Timed up and go measurement of lower limb strength
|
12 weeks
|
Fear of falling
Time Frame: 12 weeks
|
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
|
12 weeks
|
Cognition
Time Frame: 12 weeks
|
The Addenbrooke's Cognitive Examination III (ACEIII) to measure cognition levels in older adults
|
12 weeks
|
Mood
Time Frame: 12 weeks
|
The 5-item Geriatric Depression Scale screening tool for depression in older adults
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emma K Stanmore, PhD, University of Manchester
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R119047/195378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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