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New breakthrough research: video games to activate people with ME

Countrygirl

Senior Member
Messages
5,427
Location
UK
Best laugh I have had all week. How desperate for research money can they get!

:p:p:D:bang-head::ill:


https://www.ncbi.nlm.nih.gov/pubmed/28765100

JMIR Res Protoc. 2017 Aug 1;6(8):e117. doi: 10.2196/resprot.7242.
Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.
Ferrar KE1, Smith AE1, Davison K1.
Author information

Abstract
BACKGROUND:
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity-related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation.

OBJECTIVE:
The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load).

METHODS:
This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant's home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end of the intervention. Health-related outcomes (eg, physical activity, blood samples, quality of life, and functioning) will be collected at baseline, end of intervention, and 6 months after intervention completion.

RESULTS:
This protocol was developed after 6 months of extensive stakeholder and community consultation. Enrollment began in January 2017; as of publication, 12 participants were enrolled. Baseline testing is scheduled to commence in mid-2017.

CONCLUSIONS:
This pilot study will provide essential feasibility and acceptability data which will guide the use of active video games for people with ME/CFS to increase their physical activity levels. Physical activity promotion in this clinical population has been poorly and under-researched, and any exploration of alternative physical activity options for this population is much needed.

TRIAL REGISTRATION:
Australia New Zealand Clinical Trials Registry: ACTRN12616000285459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370224 (Archived by WebCite at http://www.webcitation.org/6qgOLhWWf).

KEYWORDS:
exercise; fatigue syndrome, chronic; video games

Edited to say it gets better! They are crowd funding to launch this research, so dig deep into your pocket folks.
 

Chocolove

Tournament of the Phoenix - Rise Again
Messages
548
Hmmmm..... I wonder what results we would find if we ran the authors' names through criminal investigation indexes esp. white collar frauds and scams. Sounds like they're looking to pick low hanging fruit from the desperate and incapacitated. Lots of predators out there looking for easy money.
 

Wonko

Senior Member
Messages
1,467
Location
The other side.
For people convinced we are just deconditioned/have flawed illness beliefs I can sort of see the logic.

Of course when it turns out they are wrong....they'll probably decide the game wasn't interesting enough and try again.

Hopefully (I haven't read the paper, just the abstract) they'll have full active monitoring rather than just when the patient is being tortured, sorry, when the game is being played, so they'll be able to see activity levels haven't increased overall.

But, as this would have a chance of undermining their own false illness beliefs, I would doubt they will go that far, I mean who cares if the patients actually improve as long as the study says they do.
 
Messages
15,786
They're still using allostatic stress bullshit as a basis for their treatment. But they seem to be acknowledging patient reports of harm from GET, and are going for an approach that uses heart rate and patient perceptions to avoid excess activity:
The current study will build on this small body of literature by investigating pacing alone versus pacing and physical activity using objective measures of physical activity and safely monitoring activity intensity via continuous HR monitoring and ratings of perceived exertion (RPE).
But they've got their heads up their asses if they think GET can be combined with pacing. They are antithetical to each other.

A bunch of psychobabble forms the basis of their hypothesis and objectives:
The primary objective of this pilot study is to investigate the feasibility and acceptability of pacing and active video gaming to increase the physical activity levels of adults with ME/CFS.

The secondary objectives of this study are to (1) explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing and conventional physical activity to increase the physical activity levels of adults with ME/CFS and (2) explore the relationship between allostatic load and physical activity in people with ME/CFS.

The related hypotheses are (1) preliminary evidence of benefit from pacing and active video gaming to increase physical activity compared to pacing alone will be demonstrated, (2) preliminary evidence of equal benefit of pacing and video gaming to increase physical activity levels compared to pacing and conventional exercise will be demonstrated, and (3) preliminary evidence of a negative relationship will be demonstrated between allostatic load and physical activity.

The people to complain to about authorizing this trial:
The study protocol has been approved by the University of South Australia Human Research Ethics Committee (protocol 0000035299). The protocol is registered with the Australia New Zealand Clinical Trials Registry [ACTRN12616000285459].

I'm not sure if it's ethical to provide a financial incentive to remain in the study (versus reimbursing for travel expenses):
At the end of the 12 months, participants still enrolled will be provided with an Xbox Kinect unit in acknowledgement of their participation.

This sounds safer and more realistic than their original plan:
Physical activity will be prescribed every second day (at the most) and perceived exertion will be monitored by the participant remaining under the set HR and RPE thresholds at all times. Participants will be in full control of their program and will be able to stop physical activity sessions entirely; plateau; or reduce frequency, duration, or intensity of sessions to manage symptom occurrences. Activity sessions can be completed in one session (eg, 1 10-minute block) or split up throughout the day.

Any activity progression will occur every 2 weeks. To be eligible to progress, participants must demonstrate symptoms are stable. Stable equates to HR and RPE zones adhered to for the 2-week period and no increase in symptoms as a result of activity. Progression can be escalated (particularly as higher volumes demonstrated) with consultation with research team and research assistant only if symptoms are stable. The active gaming or conventional activity will be encouraged on those days that the participants consider there to be adequate energy to do all activities of daily living usual for that person. Participants will also be encouraged to consider cognitive activities as potentially draining in addition to physical activities.

They don't require PEM, but they exclude Oxford at least. But it still allows for Fukuda recruitment, where having ME is optional:
Self-reported diagnosis of ME/CFS by a general practitioner or medical specialist based on one of the commonly accepted criteria (the Oxford Criteria is not acceptable)

This seems to restrict the study to mild (or non-ME) patients only, since 5 minutes of light activity is otherwise likely to result in overly elevated heart rate:
Exclusion criteria:
  • Self-reported aggravation of symptoms with 5 or fewer minutes of screen time
  • Self-reported aggravation of symptoms with 5 or fewer minutes of light intensity physical activity or movement

They're using 2-day CPET only for baseline, and not as an outcome measurement:
Prior to randomization, 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 predicted with the maximal protocol.

Effort testing on a bicycle ergometer is required to accurately determine the HR and RPEs at ventilatory threshold (VT) 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 [23] and will be employed in this study for all 3 arms.

They consulted with a couple ME organizations and supposed (unnamed) experts, which may be why they're planning for a crash after the CPET(s) now:
There will be at least 4 weeks between effort testing and commencement of the intervention with 2 weeks being stable at a pretest pattern of symptoms/activity. Participants may require longer recovery before commencing the intervention.

I like that they're using objective measurements, though it's not clear if they are primary outcomes:
All health-related outcomes will be measured at 3 time points: baseline, 6 months after baseline at the end of the intervention, and at 6-month follow-up after the intervention has been completed. In addition, accelerometer, inclinometer, and continuous captured HR will be measured during week 6, week 12, and week 18 of the intervention. The Karnofsky Scale [25] will be collected more frequently, with the research assistant recording the Karnofsky Scale value each time telephone contact is made with a participant.

They're taking the PACE approach to adverse events, and they're only "serious" if death or long-term disability results. And of course, a colleague of the researchers (one of the unnamed medical advisors) get to decide if it's a reaction to the treatment or not. But non-serious adverse events do get stratified based on severity, which is an improvement:
A nonserious adverse event (NSAE) will be any health event that was not categorized as an serious AE or serious adverse reaction. NSAEs will be rated as mild, moderate, or severe by both the participant (at the time of reporting) and a medical specialist. The duration of any increases in severity or disability from these events will also be recorded.

Their status update indicates they have recruited 12 out of 30 of the patients they're looking for:
Virtual meetings allowed for interactive group discussion, and consensus was reached on all aspects of the protocol. All members of the stakeholder advisory group have endorsed the current protocol. Enrollment began in January 2017; as of publication, 12 participants were enrolled. Baseline testing is scheduled to commence in mid-2017.

Who to blame for the funding:
This project is funded by the Mason Foundation National Medical Program (MAS2015F053).
 

CFS_for_19_years

Hoarder of biscuits
Messages
2,396
Location
USA

Alvin2

The good news is patients don't die the bad news..
Messages
2,984

JaimeS

Senior Member
Messages
3,408
Location
Silicon Valley, CA
Pfft, not with a degree from a school of exercise, nutrition, and activity :rolleyes:

We need testing done by exercise physiologists! Decent, logical testing.

I wouldn't be surprised if they find funding. The whole vibe these days is about 'sexy science' that's a cross between quantum theory and magical thinking. Video games solving energetic diseases fits right into the super-sexy model. And it sounds basically like this:


Very saleable.
 

Hutan

Senior Member
Messages
1,099
Location
New Zealand
http://www.researchprotocols.org/2017/8/e117/

There's a link to donation collections on this page.

I've just donated US$0.10 in order to find out if there is any way to leave comments. There is only a field to say if you want your donation to be acknowledged and, if so, how. I wrote a message there, but it may well not get seen.

Probably by the time taxes and fees are added, the cost to the donor will increase quite a bit. I think it would be better to email comments to the researchers directly.

Here's the contact email given on the research protocols page. Email: katia.ferrar [at] mymail.unisa.edu.au
 

Alvin2

The good news is patients don't die the bad news..
Messages
2,984
You know i'm starting to think all studies should have the cost to conduct them on the last page so we can see if value was received for the money and so we can see how money is wasted in studies like these.