Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis

Abstract

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.

Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training – data from the Phys-Can study

“…The incidence of coach-and participant reported ex-AEs was higher in this study than previously reported in exercise trials for cancer patients [4,13]. The reason for this may be that we included all, even minor ex-AEs, and gathered the data in a systematic way [13] as well as having different definitions of ex-AEs.…”

“…The incidence of coach-and participant reported ex-AEs was higher in this study than previously reported in exercise trials for cancer patients [4,13]. The reason for this may be that we included all, even minor ex-AEs, and gathered the data in a systematic way [13] as well as having different definitions of ex-AEs. For instance, other studies including women with breast cancer exercising at HI having reported no ex-AEs when participants reported ex-AEs to the coaches [32], or minor ex-AEs, such as hypotension or dizziness after maximal treadmill testing while monitored by coaches [39].…”

“…In reviews of exercise trials for persons with cancer, it has repeatedly been stated that exercise is safe during treatment for most individuals [4,[10][11][12] and reports of exercise related serious AEs (ex-SAEs) due to exercise during are rare. However, it has also been recognized that ex-AE reporting is neither systematic nor standardized across studies (e.g., definition of AEs and information on data collection methods are lacking) [10,11,13]. This causes difficulties in determining if persons with cancer engaging in exercise experience more ex-AEs than individuals without cancer, and if there are any treatment or exercise-related factors associated to occurrence of ex-AEs.…”

“…A systematic review of randomized controlled exercise trials (RCTs) [13] including persons with cancer (and other diagnostic groups) did not find evidence for increased risk of ex-SAEs leading to hospitalization, severe impairment or death, in intervention groups compared to non-exercising controls. However, the authors found a 19% increased risk of non-serious ex-AEs (e.g., pain, fatigue, bursitis).…”

East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol

“…As such the risk of severe or unexpected adverse events (AE) is low. 28 Exercise and an increase in physical activity may initially increase the risk of AEs such as pain, fatigue or muscle soreness or increased falls through increased activity. To reduce the risk of AEs the exercise programme will be tailored to the abilities of the participants.…”