- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029285
Exergaming Experience of Older People With Chronic Musculoskeletal Pain
The Effects of Exergaming on Pain, Postural Control, Technology Acceptance and Flow Experience in Older People With Chronic Musculoskeletal Pain: a Randomised Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study design: A prospective, randomized, controlled two-arm trial design: Group 1) exergaming with the Interactive Rehabilitation and Exercise System (IREX®) and Group 2) traditional gym-based exercise (TGB).
Ethical Approval was sought from and granted by the School of Health and Social Care Research Governance and Ethics Committee at Teesside University on 20th September 2010 The study was conducted in the Physiotherapy Research Laboratory, Constantine Building, Teesside University.
Participants were recruited by non-direct contacts from nine local community groups in the Middlesbrough area.
Sixty-one potential participants were screened for eligibility. Four were excluded due to not meeting the eligibility criteria and three did not attend scheduled sessions. Fifty-four (42 females and 12 males, age: 71 ± 5 years) were allocated to either exergaming with the IREX™ (n = 27) or TGB (n = 27).
Procedure
On arrival for data collection at the Physiotherapy Research Laboratory at Teesside University, participants were asked if they had further questions about the study. These questions, if any, were answered. The study Consent Form was then signed. Participants' demographic details and all outcome measures were recorded, after which the participants were randomised by stratified blind-card allocation (picking a sealed opaque envelope).
Data extraction
Range and Standard Deviation (SD) of Centre of Pressure (CoP) displacements in the anterior-posterior (AP) and medio-lateral (ML) directions (CoPAP SD, CoPAP range, CoPML SD, CoPML range - all mm) and the resultant CoP velocity (mm.sec-1) were extracted from the force platform using Bioware software (Kistler™), after low-pass filtering of the raw data at 10 Hz. CoP velocity (mm.sec-1) was calculated.
Statistical analysis
Data was analysed with Version 19 of the Statistical Package for the Social Sciences (SPSS, Chicago, Illinois, USA). Analysis of covariance (ANCOVA) was used to assess between-group final scores for each outcome measure used with baseline scores as covariate. Variables that did not meet the assumption of homogeneity of variance were analysed by two-way independent measures ANOVA with blocking using mean splits of scored pre-measures. Mixed analysis of variance (ANOVA) was used to determine any within-subject changes over time. All analyses used a significance level of 0.05. The effect size measure epsilon squared was used, where values of 0.01, 0.06 and 0.14 were interpreted as small, moderate and large.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cleveland
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Middlesbrough, Cleveland, United Kingdom, TS1 3BA
- Teesside University, School of Health and Social Care
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- male or female
- aged 65 years or over
- able to walk unassisted (i.e. did not use, or require, any walking aids) for at least 0.5 of a mile
- having musculoskeletal pain in two or more joints, of more than 12 weeks duration
Exclusion Criteria:
- diagnosis (or suspicion) of any systemic conditions that may cause pain in two or more joints
- of more than 12 weeks duration (such as cancer, rheumatic or neurological disease or condition)
- self-report of current (or history) of any condition or injury which would contra- indicate participation in the exercises under study
- inability (or any doubt of ability) to give informed consent
- inability to read and write English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Traditional Gym Based exercise - Control
Twice weekly sessions of TGB exercise for six weeks.
|
The exergaming group played six IREX® exergames.
Those in the TGB group performed exercises that were matched to the IREX® exergames for: movement patterns required, physiological demands, sequence, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading, across both groups.
Each IREX® exergame was played for two minutes and was repeated three times within a session.
TGB exercise was conducted in sets of two minutes duration, repeated three times within a session.
In both groups participants were given rest periods of 10 to 30 seconds, or longer, if required, between exergames or TGB exercise sets.
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EXPERIMENTAL: Exergaming
Twice weekly sessions of exergames for six weeks.
|
The exergaming group played six IREX® exergames.
Those in the TGB group performed exercises that were matched to the IREX® exergames for: movement patterns required, physiological demands, sequence, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading, across both groups.
Each IREX® exergame was played for two minutes and was repeated three times within a session.
TGB exercise was conducted in sets of two minutes duration, repeated three times within a session.
In both groups participants were given rest periods of 10 to 30 seconds, or longer, if required, between exergames or TGB exercise sets.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002).
Time Frame: Change in MAPS Cluster Score, from baseline to six weeks
|
MAPS comprises three superclusters reflecting three major aspects of pain: somatosensory, emotional and well-being.
Descriptors are presented as statements and participants rate how closely each comes to describing how they feel on a six point scale (from 0 (Not at all) to 5 (Very much so)). Descriptor scores are summed to give Cluster scores. An increased score in somatosensory and emotional clusters reflects a worsening, in well-being it reflects an improvement. |
Change in MAPS Cluster Score, from baseline to six weeks
|
Change in Pain intensity (within previous 30 days) rating
Time Frame: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
|
Participants rated the intensity of their pain (within previous 30 days) on a 0-10 scale where 10 is the WORST POSSIBLE PAIN.
An increased score represents greater pain.
|
Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
|
Change in Pain intensity (at present time) rating
Time Frame: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
|
Participants rated the intensity of their pain (within previous 30 days) on a 0-10 scale where 10 is the WORST POSSIBLE PAIN.
An increased score represents greater pain.
|
Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
|
Change in rate of change of centre of pressure (mm.s-1) location - eyes open.
Time Frame: Change in centre of pressure velocity (mm.s-1) (eyes open), from baseline to six weeks
|
Centre of pressure velocity (mm.s-1) is the rate at which the centre point of force (measured on a Kistler™ Force Plate) moves, as the participant stands on the force plate with their eyes open. It is quantified in mm.s-1 and an increase represents faster movements and hence more rapid corrections of balance are required to maintain equilibrium and hence postural control has worsened. |
Change in centre of pressure velocity (mm.s-1) (eyes open), from baseline to six weeks
|
Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes open.
Time Frame: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes open), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened. |
Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes open), from baseline to six weeks
|
Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes open.
Time Frame: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction (eyes open), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened. |
Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction (eyes open), from baseline to six weeks
|
Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.
Time Frame: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened. |
Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
|
Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.
Time Frame: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened. |
Change in range of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
|
Change in rate of change of centre of pressure (mm.s-1) location - eyes closed.
Time Frame: Change in rate of change of centre of pressure (mm.s-1) location (eyes closed), from baseline to six weeks
|
Centre of pressure velocity (mm.s-1) is the rate at which the centre point of force (measured on a Kistler™ Force Plate) moves, as the participant stands on the force plate with their eyes closed. It is quantified in mm.s-1 and an increase represents faster movements and hence more rapid corrections of balance are required to maintain equilibrium and hence postural control has worsened. |
Change in rate of change of centre of pressure (mm.s-1) location (eyes closed), from baseline to six weeks
|
Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes closed.
Time Frame: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes closed), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened. |
Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes closed), from baseline to six weeks
|
Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes closed.
Time Frame: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction(eyes closed), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened. |
Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction(eyes closed), from baseline to six weeks
|
Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.
Time Frame: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes closed), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure. It is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened. |
Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes closed), from baseline to six weeks
|
Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.
Time Frame: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction(eyes closed), from baseline to six weeks
|
Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure. It is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened. |
Change in range of centre of pressure (mm) location measurements in the medio-lateral direction(eyes closed), from baseline to six weeks
|
Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire (Venkatesh, 2003).
Time Frame: Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire, from baseline to six weeks
|
The UTAUT comprises statements rated on a 7-point Likert scale, 1 strongly disagree to 7 strongly agree, grouped into six domains.
Statement ratings are summed to give Domain scores. An increased score in any Domain reflects an increase in acceptance (positive outcome in respect of technology usage). |
Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire, from baseline to six weeks
|
Change in score on each sub-scale included in the Flow State Scale (FSS) (Jackson and Marsh, 1996).
Time Frame: Change in score on each sub-scale included in the Flow State Scale questionnaire, from baseline to six weeks
|
FSS comprises 36 questions rated on a 5-point Likert scale 1 strongly disagree to 5 strongly agree, grouped into nine subscales.
Question ratings are summed to give subscale score. An increased score in any subscale reflects an increase in the experience of Flow State (a positive outcome in respect of experience of any activity). |
Change in score on each sub-scale included in the Flow State Scale questionnaire, from baseline to six weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alasdair MacSween, Teesside University
Publications and helpful links
General Publications
- Clark CW, Yang JC, Tsui SL, Ng KF, Clark SB. Unidimensional pain rating scales: a multidimensional affect and pain survey (MAPS) analysis of what they really measure. Pain. 2002 Aug;98(3):241-247. doi: 10.1016/S0304-3959(01)00474-2.
- Jackson SA. Toward a conceptual understanding of the flow experience in elite athletes. Res Q Exerc Sport. 1996 Mar;67(1):76-90. doi: 10.1080/02701367.1996.10607928.
- Shamliyan TA, Wang SY, Olson-Kellogg B, Kane RL. Physical Therapy Interventions for Knee Pain Secondary to Osteoarthritis [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Nov. Report No.: 12(13)-EHC115-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK114568/
- Ditchburn JL, van Schaik P, Dixon J, MacSween A, Martin D. The effects of exergaming on pain, postural control, technology acceptance and flow experience in older people with chronic musculoskeletal pain: a randomised controlled trial. BMC Sports Sci Med Rehabil. 2020 Oct 9;12:63. doi: 10.1186/s13102-020-00211-x. eCollection 2020.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ExergamingOldPeople
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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