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Exercícios Sham e Placebo

 

Exercise: “exercise … is a sub‐category of physical activity that is planned, structured, repetitive, and aims to improve or maintain one or more components of physical fitness promote good physical health” (WHO, 2015). This encompasses a heterogeneous set of treatments prescribed or planned by a health professional that include conducting specific activities, postures and/or movements with a goal to reduce pain and functional limitations (Abenhaim, 2000).
Sham exercise: Can be understood as the prescription of exercise in a purposely incorrect or theoretically irrelevant way regarding the type (movement, contraction) and dose (intensity, frequency, period, duration). (Geneen et al., 2017)

Exemplos de como os exercícios sham foram operacionalizado nos estudos:

REFERÊNCIA DO ARTIGO E QUALIDADE METODOLÓGICA CONTROLE COM EXERCÍCIO SHAM OU PLACEBO
Ganderton C et al. Gluteal Loading Versus Sham Exercises to Improve Pain and Dysfunction in Postmenopausal Women with Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial. J Womens Health (Larchmt). 2018 Jun;27(6):815-829. <https://pubmed.ncbi.nlm.nih.gov/29715073/>. [8/10 PEDro, 94 participantes, 2 grupos] Sham exercises: Exercise program that predominately involved seated exercises not aimed at therapeutic loading of the gluteal tendons or strengthening of the kinetic chain (variations of seated gluteal activation exercises, seated knee extension, and seated calf raises). Dosage instructions for all exercises reflected those of the GLoBE program dynamic exercises.
McCaskey MA et al. Postural sensorimotor training versus sham exercise in physiotherapy of patients with chronic non-specific low back pain: An exploratory randomised controlled trial. PLoS One. 2018 Mar 9;13(3):e0193358. <https://pubmed.ncbi.nlm.nih.gov/29522571/> [8/10 PEDro, 22 participantes, 2 grupos] Sham exercises: Sub-effective low-intensity cardiovascular training (i.e. at an inadequate dose to produce effects). Physical activity at low intensity for only 15 minutes is not expected to induce a specific treatment effect to the sensorimotor system.
Hegde SV et al. Effects of Yoga Versus Sham Yoga on Oxidative Stress, Glycemic Status, and Anthropometry in Type 2 Diabetes Mellitus: A Single-Blinded Randomized Pilot Study. Int J Yoga Therap. 2020 Jan 1;30(1):33-39. <https://pubmed.ncbi.nlm.nih.gov/31283365/>. [8/10 PEDro, 40 participantes, 2 grupos]
Albert HB, Manniche C. The efficacy of systematic active conservative treatment for patients with severe sciatica: a single-blind, randomized, clinical, controlled trial. Spine (Phila Pa 1976). 2012 Apr 1;37(7):531-42. <https://pubmed.ncbi.nlm.nih.gov/21494193/>. [7/10 PEDro, 181 participantes, 2 grupos] Sham exercises: Sham exercises consisted of optional exercises that were not back related but were low-dose exercises to simulate an increase in systemic blood circulation.
Herdman SJ et al. Recovery of dynamic visual acuity in unilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2003 Aug;129(8):819-24. <https://pubmed.ncbi.nlm.nih.gov/12925338/>. [7/10 PEDro, 21 participantes, 2 grupos] Placebo exercise: The placebo exercise group also performed gait and balance exercise, but exercise that specifically incorporated head movements were avoided.
Venosa AR, Bittar RS. Vestibular rehabilitation exercises in acute vertigo. Laryngoscope. 2007 Aug;117(8):1482-7. <https://pubmed.ncbi.nlm.nih.gov/17592393/>. [3/10 PEDro, 87 participantes, 2 grupos] Placebo exercise: The placebo exercises performed by the CG consisted of fixation of the gaze on a visual target without moving the head, while blinking the eyes. The principal investigator explained the exercises to each patient separately and instructed that they should be performed at home, 3 times a day for 3 weeks.
Semciw AI et al. Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial – Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial. Trials. 2018 Sep 20;19(1):511. <https://pubmed.ncbi.nlm.nih.gov/30236151/>. [Protocolo de estudo, ?/10 PEDro, ? participantes, 2 grupos] Sham exercises: The sham programme differs to the GHOst protocol in that it is not aimed at strengthening the gluteal muscles, but includes generalised lower-limb, low-intensity resistance exercise. Participants are guided through sham gluteal, quadriceps’ and calf exercises, predominantly in a seated position (unloaded).
Lange AK et al. Resistive Exercise for Arthritic Cartilage Health (REACH): A randomized double-blind, sham-exercise controlled trial. BMC Geriatr. 2009 Jan 13;9:1. <https://pubmed.ncbi.nlm.nih.gov/19144148/>. [Protocolo de estudo, ?/10 PEDro, ? participantes, 2 grupos] Sham exercises: The sham intervention was designed to closely replicate virtually all of the elements of the active exercise condition (modality, setting, supervision, equipment, volume, duration, frequency) with the notable exception of intensity, as we hypothesized that intensity would be the critical prescriptive element leading to robust adaptations in both proximal (muscle and tendon strength/hypertrophy) and distal outcomes (cartilage morphology) outcomes. Participants randomized to the sham-exercise group trained on the same equipment as the intervention group except hip adduction, and performed knee extension bilaterally. Minimal resistance was set on the machine (weight of bar/foot plates only) and no progression was introduced. Exercise volume was reduced to 2 sets of 8 repetitions, using same speed as in the PRT group.

Results that support the hypothesis that exercise affects health in part or in whole via the placebo effect.

 

Efeitos psicológicos (confundidores)

Antítese

Placebo mechanisms

Clinical Use of Placebo Effects

Qualidade das evidências

Notas

  • As the comparisons between exercise and no exercise cannot be blinded, both performance and response bias are possible. Similarly, while we considered the risk of bias of unblinding low in most studies comparing acupuncture and sham acupuncture, providers obviously were aware of the treatment provided and, as such, a certain degree of bias of our effect estimate for specific effects cannot be entirely ruled out. (Vickers et al, 2012).
  • No blinding therapists (performance bias).
  • Intervention X was compared to a variety of control procedures, from which various conclusions emerge. First, intervention X was superior to waiting-list control [11], which lends support to the overall effectiveness of intervention X. This apparent effectiveness could be due to placebo effects [41] or specific effects of intervention X. Third, the effect of intervention X seemed similar to that of sham transcutaneous electrical nerve stimulation (TENS). It is difficult to draw meaningful conclusions using sham TENS as a control, since it is not an actual therapy, and it can easily be distinguished from genuine Intervention X. Ter Riet et al. [7] described the use of sham TENS as a control for intervention X as a ‘fatal mistake’ in scientific terms. Fourth, intervention X was compared with an indistinguishable control proced ure in five studies [13, 15, 20, 26, 35]. This is necessary for blinding of the subjects in order to test whether the effect of intervention X is type specific and dose/technique specific. Four of these studies were negative. This suggests that intervention X performed at carefully selected type with precise dose/techniques produces no better results than the generalized physiological response that may occur after random needling of the skin [42, 43]. However, this conclusion is far from definite. (White; Ernst, 1999. PMID: 10342627).
  • “Given the evidence that exercise A is not superior to other forms of exercise, the choice of exercise for condition A should probably depend on patient or therapist preferences, therapist treining, costs and safety. (Saragiotto et al., 2016 – PMID: 26742533)”.
  • What prevents adherence: increased pain during exercise, low levels of physical activity, lack of time, lack of energy, too difficult, no support, no facilities/safe enviroment, poor body image, cost. (Kathleen Sluka, 2022 – Abrafito).
  • Activity modulates the balance between excitation and inhibition. (Kathleen Sluka, 2022 – Abrafito).
  • Type of exercise not important for efficacy. (Kathleen Sluka, 2022 – Abrafito).
  • Given that exercise is safe, effective, and works on multiple pain mechanisms, exercise should be a primary choice for treatment of pain. (Kathleen Sluka, 2022 – Abrafito).
  • Tipos de vieses em estudos epidemiológicos.
  • Expectation <https://academic.oup.com/ptj/article/90/9/1345/2738139?searchresult=1>
  • Non-Exercise Placebo: detuned short wave, detuned ultrasound, sham TENS.
  • Non-Exercise control: no intervention, minimal interevention, hands-on, hands-off.
  • Características dos tipos de exercícios: Owen et al., 2020; Doi: 10.1136/bjsports-2019-100886
  • Classificação dos tipos de exercício: Hayden et al., 2021; Doi: 10.1002/14651858.CD009790.pub2
  • Características da dose do exercício: Polaski et  al., 2019. Doi: 10.1371/journal.pone.0210418
  • What are the limitations of the evidence? Because we did not find any trials comparing yoga to sham yoga, we cannot say how yoga would affect low back pain if people did not know they were doing yoga. Participants in all the trials were aware of whether they were practicing yoga or not, and this may have influenced their interpretation of whether their back pain had changed. Given the lack of trials of sham yoga, there is also a need for additional methodologic research in this field, particularly into the potential influence of people’s preferences and expectations on outcomes within randomized trials of yoga. We found no studies comparing yoga to a sham yoga intervention for chronic low back pain. A sham comparison to yoga would clarify the extent to which the eFects of yoga are related to the belief that participants are practicing yoga. Depending upon the form of the sham, this could serve as a blinded comparison between yoga and another active intervention. For example, if a yoga intervention was compared to an exercise intervention that is not yoga, but that participants believe is yoga, we would have information on a blinded comparison between yoga and the other exercise. PMID: 36398843
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