Clinical trial NCT04029285: Exergaming Experience of Older People With Chronic Musculoskeletal Pain
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Musculoskeletal Pain Disorder
Keywords: Exergaming
Exercise Therapy
Musculoskeletal Pain
Aged, Aged 80 and Over
Postural Balance
Flow state experience
Technology acceptance
Heart Rate
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to either the control group (TGB) or the experimental group (exergaming) in parallel for the duration of the study.
Primary purpose: OTHER

Brief summary: Chronic musculoskeletal pain is debilitating and can lower the quality of life in older people. Therapeutic benefits have been reported from exergaming used as an intervention for rehabilitation or alternative to exercise. This study investigated the effects of exergaming in comparison with those of standard exercise on pain, postural control, technology acceptance and flow experience in older people with musculoskeletal pain.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002).
timeFrame: Change in MAPS Cluster Score, from baseline to six weeks
measure: Change in Pain intensity (within previous 30 days) rating
timeFrame: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
measure: Change in Pain intensity (at present time) rating
timeFrame: Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks
measure: Change in rate of change of centre of pressure (mm.s-1) location - eyes open.
timeFrame: Change in centre of pressure velocity (mm.s-1) (eyes open), from baseline to six weeks
measure: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes open.
timeFrame: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes open), from baseline to six weeks
measure: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes open.
timeFrame: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction (eyes open), from baseline to six weeks
measure: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.
timeFrame: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
measure: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.
timeFrame: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks
measure: Change in rate of change of centre of pressure (mm.s-1) location - eyes closed.
timeFrame: Change in rate of change of centre of pressure (mm.s-1) location (eyes closed), from baseline to six weeks
measure: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes closed.
timeFrame: Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes closed), from baseline to six weeks
measure: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes closed.
timeFrame: Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction(eyes closed), from baseline to six weeks
measure: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.
timeFrame: Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes closed), from baseline to six weeks
measure: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.
timeFrame: Change in range of centre of pressure (mm) location measurements in the medio-lateral direction(eyes closed), from baseline to six weeks
measure: Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire (Venkatesh, 2003).
timeFrame: 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
measure: Change in score on each sub-scale included in the Flow State Scale (FSS) (Jackson and Marsh, 1996).
timeFrame: Change in score on each sub-scale included in the Flow State Scale questionnaire, from baseline to six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University, School of Health and Social Care
state: Cleveland
Study officials:
affiliation: Teesside University
name: Alasdair MacSween
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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/
citation: 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.