NCT02634736

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

December 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

December 9, 2015

Last Update Submit

October 25, 2017

Conditions

Accidental Falls

Outcome Measures

Primary Outcomes (1)

  • Balance

    The Berg Balance Scale (BBS)

    12 weeks

Secondary Outcomes (6)

  • Adherence

    12 weeks

  • Physical activity levels

    12 weeks

  • Lower limb strength

    12 weeks

  • Fear of falling

    12 weeks

  • Cognition

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Exergame plus usual treatment

EXPERIMENTAL

Exergame programme plus usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists).

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).

Interventions

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).

Exergame plus usual treatment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Emma Stanmore

Manchester, Lancashire, M13 9PL, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30813926DERIVED

Study Officials

  • Emma K Stanmore, PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 18, 2015

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

September 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)