It is known that the control of intensity in a physical exercise program is very important to achieve expected physiological adaptations. Although some studies have reported benefits for your health, will this be an ethical decision?
Edgardo Molina-Sotomayor
AS long as the persons give their informed consent you can design an experiment
with for example 3 different age groups so that you have something to compare.
If you think that the elderly will die from the experiment you have to adjust the intensity of the training. Finally it is the Ethics Committee that gives the permission and you have to do it as ethical as possible and leave the persons in the same or in better health according to the rules. We tested the exercise on MS model mice to see if MS patients could benefit from exercise.
Running wheel activity restores MPTP-induced deficits
- March 2011
- Journal of Neural Transmission 118(3):407-20
DOI:10.1007/s00702-010-0474-8
The Ethics Committee are tasked to do the risk-benefit assessment based on your description in the application. So if I was a member of the Committee, my concern had been to ensure that the risks the participants are exposed to are justified and minimized and that the consent information is written in a style the presumptive participants can understand. Your task as a researcher is to justify and minimize the risks, inform the participants about the risks, be sure that they have understood the information, and withdraw from the study at any time.
I would want to know how strenuous it will be and whether there is a physician clearance for that degree of physical demand. Are geriatricians part of the research team? So I am looking for inclusion criteria and exclusion criteria. Who will be in the location with subjects? Will they have equipment present if there is a medical crisis? Will subjects be encouraged to stop if they feel stressed? What are the rules for stopping in a session and wanting to return to other sessions? If there are charges for treatment if a crisis occurs, who will pay the fees? etc
Thank you very much Béatrice Marianne Ewalds-Kvist for sharing your opinion. The question is NOT related to procedural or methodological aspects, but rather, to the high risk of high-intensity exertion in sedentary older people. In the question that was asked, the control of intensity was already defined as HIGH. Although beneficial physiological adaptations have been reported by these physical practices, in young people, adults and older adults, their realization is also associated with an increased cardiovascular risk among others, especially in the population of older adults. Therefore, if benefits have been observed for some groups of older adults and perhaps for other older adults, they could be very dangerous. Do we approve it or do we not approve it?
Thanks Tove Godskesen, I theoretically share your opinion in relation to the risk-benefit evaluation, I also share that the risks must be controlled, that the subjects must be duly informed and that they can withdraw from the study, at any time. However, in practice on the ground, the risks induced by the implementation of maximum intensity efforts could be fulminating for a no small sector of this population. The responses of this type of exercises will not respect any of the ethical protocols considered above, being able to trigger in the best of cases, unwanted physiological responses and in the worst case accidents of all kinds, being able to reach death
Edmund L. Erde
Thank you Edmund L.Erde for responding. In my opinion, the methodology of the study and compliance with ethical protocols are important. However, high-intensity exercise can produce among others; traumatic injuries from falls, fractures, or fibrillar ruptures. Microtraumatisms that produce chronic lesions; inflammatory or degenerative (tendonitis, chondromalacia etc.). Lipothymia due to lack of glucose in the brain, suppression of the immune system, cardiometabolic alterations etc. Therefore, ethical and methodological protocols will be sufficient to avoid unexpected responses? Will it be enough?
Yes absolutely! As long as the persons have given their consent. Why should they be excluded? Older is a term that includes people from about 55-100 years or more. Of course, they can not have the same high-intensity training. Can not see why the ethics committee should not approve this.
You identified some risks that are very important to the consent process. I am now aware that I should have asked about the design. What is the hypothesis for the study? What contribution to knowledge will running the study do? Are there many seniors who are obsessed with the sort of exercise you described or is the idea for the study entirely born from the minds of the researchers? Risk/benefit ratios seem inappropriate.
Ethics committee exit to protect Research participants, through informed consent, minimizing risk and maximizing benefits well as ensuring justice and privacy and confidentiality. If from the risk/ benefit ratio analysis, the risk is adjudged to be higher than the benefits, then I will not encourage ethical approval of such study.
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