Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000285459
Ethics application status
Approved
Date submitted
29/02/2016
Date registered
4/03/2016
Date last updated
5/02/2021
Date data sharing statement initially provided
29/01/2019
Date results information initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring pacing to increase physical activity: Is active video gaming a feasible and acceptable strategy for adults with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS)?
Scientific title
A pilot study exploring pacing to increase physical activity: Is active video gaming a feasible and acceptable strategy for adults with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS)?
Secondary ID [1] 288639 0
MAS2015FO53
J J Mason and H S Williams Memorial Foundation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic fatigue syndrome 297813 0
myalgic encephalomyelitis 297859 0
Condition category
Condition code
Other 297988 297988 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pilot randomised controlled trial is a 3-arm trial of 6 months duration and 6 month follow-up. One arm pacing, another pacing plus conventional physical activity and the third pacing plus active video gaming. The pacing only arm is considered the active control, as so many people with ME/CFS already 'pace' their activities, the research team was advised by the Stakeholder Advisory Group to include pacing as the control situation.
Prior to randomisation, participants will be screened for eligibility and will participate in either a maximal effort 2 day testing protocol or a submaximal effort protocol. A submaximal effort protocol has been included as an option as community feedback indicated unwillingness from some people due to the potential symptom flare-up with the maximal protocol.
Effort testing on a bicycle ergometer is required to accurately determine the heart rate and ratings of perceived exertion (RPE) at ventilatory threshold (or 10% below the VT) for each participant. This 10% below VT has been posited as a preferred limit to stay below to avoid symptom flare-up and will be employed in this study for all three arms.
The two day maximal effort testing protocol is a smaller study running concurrently and is looking to confirm the differing physiological responses demonstrated by people with ME/CFS during repeat exercise testing when compared to healthy controls, due to post-exertional malaise. The comparison to control is not part of this study.
2 Day maximal effort test:
On two consecutive days (at the same time of day), a subjective questionnaire regarding fatigue status will be completed. Following this, 10 minutes rest while wearing HR monitor. The incremental exercise test progresses from very light to maximal exercise over a period of 8-12 minutes. The test starts with a 5 minute, 40 W warm up, during which rate of heart rate increase is assessed. Following this 5 minutes, the test increases using a ramp protocol, with increases of 5 watts every 20 seconds (so 15watts/min on average). The test finishes when the participant reaches volitional exhaustion, so when they feel they have done all that they can.
Submaximal effort test:
On one occasion, wearing a gas analysis machine and on a cycle ergometer starting at a work rate of 25 watts and increasing by 15 Watts each minute until a heart rate of 85% of age predicted maximum is achieved (208-[0.7xage]). The test will be terminated prior to this point if participants reach voluntary exhaustion, an RPE of 19, RER of greater then 1.15 or a plateau in HR or VO2 with increasing work rate.
Recommended exercise intensity will be limited to a HR corresponding to 10% below measured ventilatory threshold (VT) or in the case that VT is not adequately detected in the exercise test then below 70% of age predicted HR max.
There will be at least 4 weeks between effort testing and commencement of protocol and 2 weeks stable at pre-test pattern of symptoms/activity.
Arm 1 is considered the active control and involves teaching the participants pacing strategies to manage activities of daily living. Pacing strategies are a commonly used and typically acceptable strategy people with ME/CFS use to manage their available energy and avoid symptom aggravation. Pacing involves reflection and understanding of available energy on any given day and organisation of activities to avoid symptom flare up and provide adequate time for rest. This group will also be provided with a heart rate monitor to assist with the pacing strategy i.e. staying in acceptable heart rate zone as determined by their effort testing at baseline. There will be no instruction to increase physical activity levels in this group – and they will be encouraged not to commence any physical activity program for the 6 month period.
Arm 2 will involve a symptom-contingent pacing protocol to increase physical activity levels using a conventional non-screen-based activity of their choice (e.g. hand pedal exercise, thera-band exercise program, walking, swimming, stationary bicycle etc).
Arm 3 will involve a symptom-contingent pacing protocol to increase physical activity levels using active video gaming.
Pacing to increase physical activity Protocol
Swapping screen time with the active gaming will be recommended. If no or minimal screen time then participants will be encouraged to swap out another activities that require low cognitive or physical load. The active video gaming and conventional physical activity is intended to be additional to existing physical activities.
Encourage the exergaming or conventional activity to be conducted on those days that the participants considers there to be adequate energy to do all ADLs usual for that person etc. Do not exceed energy envelope. Encourage participants to also consider cognitive activities as potentially draining – so consider swapping them onto non-intervention days if necessary.
Every second day at the most exergaming or physical activity. Participants in the exergaming arm will be provided with a XBox Kinect and will be instructed how to play dance or sporing games some of which can be played seated/reclining. A trained research assistant will visit the participants in their homes to set up the console. It is expected the initial visit will take approximately 1.5 hours to set up the equipment and train the participant how to use the console.
The participants will be required to keep their heart rate and RPE below the stipulated level for all activities, and for the physical activity sessions. If a physical activity session exceeds the RPE (even though the HR may be in the acceptable zone) this would not be considered as symptom stable – and an additional week at the same intervention level will be required complying to the individualised maximum heart rate and RPE or lower.
Based on self-reported amount of activity from symptom history questionnaire and self-reported tendency (boom/bust or avoid) then baseline amount of exergaming/physical activity (PA) will be negotiated.
Pacing protocol will be tiered in 3 levels: light tolerance equals able to participate in light activity for at least 5 minutes (but less than 10 minutes), starting at 2 minutes of PA/session progressing by 30secs-1min/session each fortnight; moderate tolerance equals able to be active for between 10-15 minutes at a light intensity with minimal or no flare up of symptoms, starting at 5min/session PA and progressing by 1-2min/session/fortnight; and high tolerance equals able to be active for 15 or more minutes at a light intensity with minimal or no flare up of symptoms, starting at 10min/session PA and progressing by 2-4 min/session/fortnight. An accredited exercise physiologist (EP) will triage/educate/monitor the programmes. The EP research assistant will call 1xweek for 3 months and 1/fortnight for 3 months. Participants can slow, regress, plateau or cease PA at any time. All participants will fill in adherence diaries.
Intervention code [1] 294052 0
Lifestyle
Intervention code [2] 294083 0
Treatment: Other
Comparator / control treatment
Arm 1 is considered the active control and involves teaching the participants pacing strategies to manage activities of daily living. Pacing strategies are a commonly used and typically acceptable strategy people with ME/CFS use to manage their available energy and avoid symptom aggravation. Pacing involves reflection and understanding of available energy on any given day and organisation of activities to avoid symptom flare up and provide adequate time for rest. This group will also be provided with a heart rate monitor to assist with the pacing strategy i.e. staying in acceptable heart rate zone and ratings of perceived exertion zone as determined by their effort testing at baseline. There will be NO instruction to increase physical activity levels in this group – and they will be encouraged NOT to commence any physical activity program for the 6 month period. All participants will be visited in their home by the accredited exercise physiologist research (EP RA) assistant at the start of the intervention. The EP RA will fit and explain the heart rate monitor, set the alarm based on the maximal effort testing results (10% below VT HR), provide the participant with a RPE chart with the preferred zone clearly marked, educate the participant re re-organisation of time, using only the available energy, avoiding peaks and troughs etc. The face-to-face contact will occur once only and is expected to take approximately 1 hour , but the RA will call participants 1/week for 3 months and 1/fortnight for 2 months (call duration expected to be approx. 20 minutes), and the participants can call the EP RA at any stage over the 6 month intervention duration.
Control group
Active

Outcomes
Primary outcome [1] 297507 0
Physical activity using 7 day accelerometry
Timepoint [1] 297507 0
baseline, 6 months, 12 months and Week 6/Week 12/ Week 18 intervention
Secondary outcome [1] 321253 0
use of time using the Multimedia Activity Recall for Children and Adults
Timepoint [1] 321253 0
baseline, 6 months and 12 months
Secondary outcome [2] 321282 0
allostatic load measured using a composite index score with measures taken from venous blood (insulin, glucose, cholesterol, triglycerides, C - reactive protein, cortisol and Interleukin-6)
Timepoint [2] 321282 0
baseline, 6 months and 12 months.
Secondary outcome [3] 321373 0
body mass index using measured height (stadiometer) and weight (Tanita electronic scales)
Timepoint [3] 321373 0
baseline, 6 months and 12 months
Secondary outcome [4] 321374 0
blood pressure using a sphygmomanometer
Timepoint [4] 321374 0
baseline, 6 months and 12 months
Secondary outcome [5] 321375 0
heart rate using a Polar heart rate monitor
Timepoint [5] 321375 0
base line, 6 months and 12 months and Week 6/Week 12/ Week 18 intervention
Secondary outcome [6] 321465 0
heart rate variability using a Polar heart rate monitor
Timepoint [6] 321465 0
baseline, 6 months, 12 monhts
Secondary outcome [7] 323589 0
diet using 3 day pen and paper diet diary
Timepoint [7] 323589 0
baseline, 6 months and 12 months
Secondary outcome [8] 323590 0
body temperature using a thermometer
Timepoint [8] 323590 0
baseline, 6 months and 12 months
Secondary outcome [9] 323591 0
maximal exercise test (two day repeated) or submaximal exercise test will be conducted to determine preferred heart rate and ratings of perceived exertion zones (range 10% below ventilatory threshold)
Timepoint [9] 323591 0
baseline
Secondary outcome [10] 329961 0
Cognitive Testing using CANTAB tests
Timepoint [10] 329961 0
baseline, 6 months, 12 monhts
Secondary outcome [11] 329962 0
Quality of life using the SF-36 Questionnaire
Timepoint [11] 329962 0
baseline, 6 months, 12 monhts
Secondary outcome [12] 329963 0
Sleep quality using the Pittsburgh Sleep Quality Index
Timepoint [12] 329963 0
baseline, 6 months, 12 months
Secondary outcome [13] 329964 0
Subjective cognitive functioning Cognitive Failure Questionnaire
Timepoint [13] 329964 0
baseline, 6 months, 12 months
Secondary outcome [14] 329965 0
Fatigue using the Chalder Fatigue Scale
Timepoint [14] 329965 0
baseline, 6 months, 12 monhts
Secondary outcome [15] 329966 0
Ability using the Karnofsky Scale
Timepoint [15] 329966 0
baseline, each phone call or contact with research assistant, 6 months, 12 months
Secondary outcome [16] 329967 0
sitting time with 7 day inclinometer
Timepoint [16] 329967 0
baseline, 6 months, 12 months and Week 6/Week 12/ Week 18 intervention
Secondary outcome [17] 329968 0
Symptom history using symptom history questionnaire
Timepoint [17] 329968 0
baseline
Secondary outcome [18] 329969 0
Sociodempgraphic data using Sociodemographic questionnaire
Timepoint [18] 329969 0
baseline
Secondary outcome [19] 329970 0
Pacing adherence using adherence diary
Timepoint [19] 329970 0
daily during intervention
Secondary outcome [20] 329971 0
Adverse events using adverse event protocol
Timepoint [20] 329971 0
throughout intervention, every contact/phonecall
Secondary outcome [21] 329972 0
Physical activity session adherence using Adherence Diary
Timepoint [21] 329972 0
daily during intervention

Eligibility
Key inclusion criteria
1. GP clearance will be required by all participants.
2. participants are required to self-report diagnosis of ME/CFS by a general practitioner or medical specialist and be based on one of the commonly accepted criteria (the Oxford Criteria is not acceptable)able to complete exercise test (either maximal or submaximal)
3. not currently playing active video games
4. low to moderate on Sports Medicine Australia Exercise Screening Tool
5. self-report less than 150 minutes of moderate intensity activity each week (not meeting National Physical Activity Guidelines)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. self-reported aggravation of symptoms with 5 or less minutes of screen-time
2. self-reported aggravation of symptoms with 5 or less minutes of light intensity physical activity or movement
3. using active video games
4. not diagnosed with ME/CFS

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer random generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
All 3 arms will participate in the intervention for 6 months and then 6 month follow-up.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Pilot study - 30 participants was deemed adequate to gain acceptability and feasibility data, and adequate efficacy data to calculate effect size and samples sizes for powered studies in the future.
Themes will be extracted and summarised from interview transcripts. Categorical questionnaire data will be analysed using chi square and continuous data via t-test or ANOVA to determine statistical differences between time points or groups as required. Random effects mixed modelling and mediation analysis will be used to investigate the relationship between CFS/ME symptom severity, allostatic load and physical activity. Effect sizes (pre-post) will be determined for physical activity (accelerometer counts/day), the primary outcome variable to inform larger powered randomised controlled studies in the future. All statistical analysis will be purely exploratory, as not powered to detect statistical differences etc.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/12/2016
Actual
1/03/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
24/01/2018
Date of last data collection
Anticipated
8/03/2019
Actual
11/06/2019
Sample size
Target
30
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 12811 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 292999 0
Charities/Societies/Foundations
Name [1] 292999 0
J J Mason and H S Williams Memorial Foundation
Country [1] 292999 0
Australia
Primary sponsor type
Individual
Name
Dr Katia Ferrar
Address
University of South Australia
City East Campus, Cnr North Terrace and Frome Road
GPO Box 2471, Adelaide SA, 5001
Country
Australia
Secondary sponsor category [1] 291771 0
None
Name [1] 291771 0
None
Address [1] 291771 0
None
Country [1] 291771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294504 0
University of South Australia HREC
Ethics committee address [1] 294504 0
University of South Australia
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 294504 0
Australia
Date submitted for ethics approval [1] 294504 0
01/03/2016
Approval date [1] 294504 0
29/04/2016
Ethics approval number [1] 294504 0
Application ID: 0000035299

Summary
Brief summary
There is much confusion in the community regarding the difference between using a Graded Exercise Therapy (GET) protocol to increase activity and a pacing protocol to increase activity. This project is using a pacing protocol to increase activity – a concept not well investigated in the literature.
Aims
1. To determine the feasibility and acceptability of pacing plus active video gaming as a management strategy to increase physical activity levels in adults with CFS/ME
2. To explore if pacing plus active video gaming is an effective management strategy to increase physical activity for people with ME/CFS
3 To explore whether pacing plus conventional physical activity differs in effectiveness to pacing plus active video gaming compared to pacing alone
4. To explore the relationship between allostatic load and physical activity in people with CFS/ME
Trial website
Trial related presentations / publications
Public notes
The project protocol has been revised and updated extensively since the first version. This has been the result of extensive Stakeholder Advisory Group and community consultation. The research team would like to thank all involved.

Contacts
Principal investigator
Name 63954 0
Dr Katia Ferrar
Address 63954 0
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country 63954 0
Australia
Phone 63954 0
+61 8 8302 2554
Fax 63954 0
+61 8 830 22853
Email 63954 0
[email protected]
Contact person for public queries
Name 63955 0
Dr Katia Ferrar
Address 63955 0
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country 63955 0
Australia
Phone 63955 0
+61883022554
Fax 63955 0
+61 8 830 22853
Email 63955 0
[email protected]
Contact person for scientific queries
Name 63956 0
Dr Katia Ferrar
Address 63956 0
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country 63956 0
Australia
Phone 63956 0
+61883022554
Fax 63956 0
+61 8 830 22853
Email 63956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1201Study protocol    https://www.researchprotocols.org/2017/8/e117/



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.