NCT04029285

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

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

Study Start

First participant enrolled

September 20, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2011

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 18, 2019

Last Update Submit

July 22, 2019

Conditions

Keywords

ExergamingExercise TherapyMusculoskeletal PainAged, Aged 80 and OverPostural BalanceFlow state experienceTechnology acceptanceHeart Rate

Outcome Measures

Primary Outcomes (15)

  • Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002).

    MAPS comprises three superclusters reflecting three major aspects of pain: somatosensory, emotional and well-being. 1. somatosensory supercluster contains 17 clusters with 57 descriptors of painful sensory qualities 2. emotional supercluster has 8 clusters with 26 descriptors of negative emotional qualities 3. well-being supercluster has 5 clusters with 18 descriptors of positive affect, and health. 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

    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

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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).

    The UTAUT comprises statements rated on a 7-point Likert scale, 1 strongly disagree to 7 strongly agree, grouped into six domains. 1. performance expectancy, the belief that using a system will help improve performance, 2. effort expectancy, how easy it is to use the technology 3. social influence, how much the user believes others think they should use the technology 4. facilitation conditions, how much the user believes they should use the technology, 5. self-efficacy, how capable the user feel to use the technology 6. behavioural intention, intention to use the technology again. 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).

    FSS comprises 36 questions rated on a 5-point Likert scale 1 strongly disagree to 5 strongly agree, grouped into nine subscales. 1. autotelic experience, the intrinsically rewarding experience doing a task 2. clear goals, clearly confident of action 3. challenge-skill-balance, balance between skills and challenge 4. concentration at task, complete control on performing a task 5. control, at full focus at the task 6. unambiguous feedback, feedback on performing a task 7. action-awareness-merging, immediate, direct and clear observations whilst performing a task 8. transformation of time, sense of time speeds or slows, becomes irrelevant or out of one's awareness 9. loss of self consciousness, sense of not being concerned with oneself while engaged in a task 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

Study Arms (2)

Traditional Gym Based exercise - Control

OTHER

Twice weekly sessions of TGB exercise for six weeks.

Other: Exergaming

Exergaming

EXPERIMENTAL

Twice weekly sessions of exergames for six weeks.

Other: Exergaming

Interventions

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.

ExergamingTraditional Gym Based exercise - Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teesside University, School of Health and Social Care

Middlesbrough, Cleveland, TS1 3BA, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 12127025BACKGROUND
  • 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.

    PMID: 8735997BACKGROUND
  • 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/

    PMID: 23213666BACKGROUND
  • 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.

MeSH Terms

Conditions

Musculoskeletal PainCollagen Diseases

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alasdair MacSween

    Teesside University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were assigned to either the control group (TGB) or the experimental group (exergaming) in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Lecturer (Research Governance)

Study Record Dates

First Submitted

July 18, 2019

First Posted

July 23, 2019

Study Start

September 20, 2010

Primary Completion

March 31, 2011

Study Completion

September 16, 2011

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations