ABSTRACT
Background
Physiotherapists have an ethical, professional, and regulatory responsibility for safety in all aspects of patient care. Notwithstanding, the adverse events issue has been inadequately addressed in the rehabilitation research field.
Objectives
To determine the frequency and characterize the adverse events that occur during or in between physiotherapy sessions for parkinsonian syndromes.
Methods
An exploratory clinical study was conducted. Physiotherapists were asked to actively report the adverse events that occurred during or between sessions for parkinsonian syndromes.
Results
A total of 100 patients were enrolled in the study, which resulted in 1845 sessions. The most common adverse events reported were falls, pain/discomfort, and hypotension, with a total of 128 adverse events reported.
Conclusions
During the physiotherapy sessions, adverse events do occur. Future research should clarify the relationship between AE occurrence and the type of intervention as well as causality and risk‐minimization strategies.
Keywords: movement disorders, Parkinson's disease, adverse events, physiotherapy, exercise, rehabilitation
When deciding which therapeutic interventions to include in disease management, patient safety is a top priority. 1 Managing risk for individual patients requires knowledge of risk factors, disease stages, contraindications to treatment, prevention of adverse events (AEs), safe and effective application of interventions, and a real‐time assessment of a patient's response to treatment. 2 The World Health Organization (WHO) defines AE as any injury associated with medical management in contrast to complications of the disease that can be divided into preventable and nonpreventable. 3 Reporting and analyzing AEs comes with numerous challenges. AE collection requires additional information to be obtained on factors such as severity, seriousness, timing and duration, number of occurrences, intervention, and causality, which were predefined for our results. 4
Physiotherapy is generally regarded as a safe intervention because it is a nonpharmacological intervention that does not require the use of drugs or invasive procedures. However, the AE topic has been inadequately addressed in the rehabilitation research field, with 72% of trials not monitoring and reporting any AEs. 5 Physiotherapists have an ethical, professional, and regulatory responsibility for patients' safety. This study aims to determine the frequency of AEs associated with physiotherapy sessions in patients with parkinsonian syndromes.
Patients and Methods
Study Design
A 17‐week exploratory clinical study was conducted. The study was approved by the Campus Neurológico‐ CNS (Reference 07–2020) and Centro Académico de Medicina de Lisboa and Centro Hospitalar Universitário Lisboa Norte (CHULN e CAML) (Reference 17/20) Independent Ethics Committees.
Participants
Patients were recruited from CNS–Campus Neurológico, a tertiary specialized movement disorders center in Portugal. Patients were eligible for the study if they had a diagnosis of Parkinson's disease (PD) or other form of parkinsonism according to the clinical diagnostic criteria6, 7, 8, 9, 10, 11 if were attending physiotherapy sessions in CNS, and if they had given their consent to participate in the study or had a legal guardian authorize participation in the study. We excluded patients who had the presence of psychosis that, according to best medical judgment, could be aggravated with participation in the study. There were no restrictions on pharmacological therapeutic adjustments.
Intervention
Physiotherapists delivered specialized physiotherapy sessions in different environments including inpatient wards, home care, and telerehabilitation. The sessions aimed to maximize the quality of movement, functional independence, and general fitness and minimize secondary complications while supporting self‐management and optimizing the patient's safety. 12 , 13 They included exercise and movement strategy training, and each was supported with information and education. 12 Effective exercise interventions included gait and balance training, 14 progressive resistance training, 15 treadmill exercise, 16 strength training,14 and aerobic exercise. 14
Study Procedures
An initial session with the physiotherapy team was held 2 weeks prior to the patients' recruitment to explain the study and teach how to report AEs followed by a period of training. All participants fulfilling the inclusion criteria were invited to participate. Information about objectives, duration, and procedures was given to patients, and written informed consent was obtained. Demographic and clinical data were collected through a clinical interview (Appendix S1).
The therapist who oversaw the session was asked to keep track of any AEs that occurred during or between sessions and filled out the reporting tool for the patients who were enrolled in the study (Appendix S1).
Study Outcomes
The primary outcome of this study was to quantify the frequency of AEs associated with physiotherapy sessions that occurred during the 17 weeks of follow‐up. For this study, AEs were defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the physiotherapy sessions.
Secondary outcomes were the following: (1) characterization of the AEs (circumstances in which the events occurred specifying the type of event, place, type of intervention, and time to the occurrence) through a reporting tool based on the Infarmed Adverse Events notification and the Council for International Organizations of Medical Sciences–Suspect Adverse Reaction Report 17 , 18 ; (2) seriousness of the AEs was measured based on the US Food and Drug Administration (FDA) for Serious Adverse Events 19 ; (3) severity of the AEs within 24 hours after the session as measured according to the terminology criteria for AEs from the US FDA 20 ; (4) patient/caregiver perception of the functional impact of the AE as measured by a 5‐point Likert scale adapted from the Safety Assessment Code Matrix 21 ; and (5) therapist perception of causality of the AE measured by the WHO–UMC ‐ Uppsala Monitoring Centre causality assessment system.
Statistical Analysis
Descriptive statistics were used for demographic, clinical, and AE‐related data. From a systematic review of the prevalence of adverse drug reactions in the primary care setting, the percentage of AEs ranged from 12.35% to 37.96%, with a pooled estimate of 22.96%. 23 A 20% rate of AEs was assumed, with a margin of error of 7.5% and a significance level of 0.05 and with an estimated sample size of 100 participants.
Results
Sociodemographic and Clinical Data
A total of 100 patients were included, and 1845 sessions were performed during the 17 weeks of the study. The mean age of the participants was 75 ± 8.5 years with a disease duration of 7 ± 4.9 years (Table 1).
TABLE 1.
Characteristics of the sample and frequency of adverse events reported
| Demographic and clinical characteristics of the sample (n = 100) | |
|---|---|
| Male gender, n (%) | 68 (68) |
| Age, yr, mean ± SD | 75 ± 8.5 |
| Diagnosis, n (%) | |
| PD | 71 (71) |
| PSP | 10 (10) |
| LBD | 8 (8) |
| VaP | 7 (7) |
| MSA | 4 (4) |
| Disease duration, yr, mean ± SD | 7 ± 4.9 |
| Motor complications, yes, n (%) | 59 (59) |
| Frequency of adverse events, n (%) | |||
|---|---|---|---|
| Total of adverse events | 128 (100) | ||
| Serious adverse events | 3 (2.3) | ||
| Adverse events that led to discontinuation | 1 (0.8) | ||
| Diagnosis (n) | Sessions (n) | Adverse events, n (%) | RR/session |
| PD (71) | 1226 | 75 (58.6) | 0.7 |
| PSP (24) | 198 | 24 (18.7) | 1.9 |
| LBD (8) | 201 | 17 (13.3) | 1.1 |
| VaP (7) | 143 | 6 (4.7) | 0.6 |
| MSA (4) | 77 | 6 (4.7) | 1.1 |
| Reported adverse events, n (%) | |
|---|---|
| Falls | 38 (29.7) |
| Discomfort/pain | 35 (27.3) |
| Hypotension | 10 (7.8) |
| Irritability | 7 (5.5) |
| Anxiety/panic attack | 5 (3.9) |
| Dizziness | 5 (3.9) |
| Hypertension | 5 (3.9) |
| Confusion/disorientation | 4 (3.1) |
| Cramps | 4 (3.1) |
| Sleeping disturbances–insomnia | 3 (2.3) |
| Fatigue/tiredness | 2 (1.6) |
| Increased dyskinesia | 2 (1.6) |
| Motor fluctuations | 2 (1.6) |
| Cardio‐respiratory arrest | 1 (0.8) |
| Nausea/vomiting | 1 (0.8) |
| Delirium | 1 (0.8) |
| Cholecystitis | 1 (0.8) |
| Dysarthria | 1 (0.8) |
| Choking | 1 (0.8) |
Abbreviations: SD, standard deviation; PD, Parkinson's disease; PSP, progressive supranuclear palsy; LBD, Lewy bodies dementia; VaP, vascular parkinsonism; MSA, multiple system atrophy; RR, relative risk.
Frequency of AEs
A total of 128 AEs were reported, which corresponds to an average of 0.07 events/session (Table 1). A total of 57 patients experienced AEs during or after the physical therapy sessions. Of these, 56.1% (n = 32) patients reported only 1 AE. A maximum of 1 AE was recorded per session.
Patients with PD showed an AE rate of 6.1%, whereas individuals with atypical parkinsonian syndrome had an 8.6% rate of AEs. Atypical parkinsonian syndrome presented a relative risk of AEs per session of 1.4 and 0.7 for patients with PD (Table 1).
Characterization of the AE
Type of AE
Falls were the most reported AE (29.7%, n = 38), followed by discomfort/pain (27.3%, n = 35) and hypotension (7.8%, n = 10) (Table 1).
Most falls (94%) occurred after physical therapy sessions, with outpatients accounting for 44.7% (n = 17) and patients with progressive supranuclear palsy accounting for 55.3% (n = 21). One of the reported falls was classified as severe, affecting the patient's self‐care activities significantly.
Discomfort/pain (27.3%, n = 35) occurred predominantly during the sessions, 57% (n = 20) of the times in patients with PD during gait training. Patients and physiotherapists described 4 episodes of pain as having a major impact on functional capacity.
Of the 80% (n = 8) of hypotension incidents recorded during sessions, 5 occurred during cardiovascular training. Patients with PD accounted for 70% (n = 7) of the hypotension events. One of the episodes was classified as serious, with a major impact on the patient's functional capacity.
Setting
Inpatient rehabilitation programs accounted for 60.9% (n = 78) of the events recorded, outpatient rehabilitation programs were responsible for 28.1% (n = 36), home care for 7.0% (n = 9), and telerehabilitation for 3.9% (n = 5).
Among the AEs that occurred during the physiotherapy sessions, 70.4% (n = 50) happened at the gym. Following the physiotherapy sessions, 60.3% (n = 35) of the events took place at home, primarily in the room, toilet, and office.
Time to event
An AE would most often occur at around 15 to 45 minutes into the physiotherapy sessions and in the first 24 hours after the physiotherapy session.
Interventions
Cardiovascular training accounted for 24.2% (n = 31), gait training for 21.1% (n = 27), balance exercises for 11.7% (n = 15), bed mobility training for 10.9% (n = 14), and strength training for 9.4% (n = 12) of the events. Other types of physiotherapy interventions, such as clinical motor assessment, boxing training, and seated mobility exercises accounted for 9.4% of the events (n = 13) (Table 2).
TABLE 2.
Adverse events that occurred during and after the sessions per type of intervention
| Cardiovascular Training | Gait Training | Bed Mobility | Hydrotherapy | Strength Training | Balance Training | Dual‐task Exercises | Functional Tasks | Flexibility | Other | Total | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse events that occurred during the sessions | |||||||||||
| Discomfort/pain | 3 | 11 | 5 | 1 | 3 | 1 | 24 | ||||
| Hypotension | 5 | 1 | 1 | 1 | 8 | ||||||
| Irritability | 2 | 3 | 2 | 7 | |||||||
| Hypertension | 5 | 5 | |||||||||
| Anxiety/panic attack | 1 | 2 | 1 | 1 | 5 | ||||||
| Dizziness | 1 | 2 | 1 | 4 | |||||||
| Other | 2 | 2 | 4 | ||||||||
| Confusion/disorientation | 3 | 3 | |||||||||
| Cramps | 2 | 2 | |||||||||
| Fatigue/tiredness | 1 | 1 | 2 | ||||||||
| Motor fluctuations | 1 | 1 | 2 | ||||||||
| Falls | 1 | 1 | 2 | ||||||||
| Nausea/vomiting | 1 | 1 | |||||||||
| Cardio‐respiratory arrest | 1 | 1 | |||||||||
| Total | 20 | 19 | 8 | 8 | 4 | 1 | 1 | 1 | 0 | 8 | 70 |
| Adverse events that occurred after the sessions | |||||||||||
| Falls | 8 | 5 | 1 | 2 | 14 | 2 | 1 | 3 | 36 | ||
| Discomfort/pain | 2 | 4 | 3 | 1 | 1 | 11 | |||||
| Sleeping disturbances–insomnia | 2 | 1 | 3 | ||||||||
| Other | 1 | 1 | 2 | ||||||||
| Hypotension | 1 | 1 | 2 | ||||||||
| Cramps | 1 | 1 | 2 | ||||||||
| Confusion/disorientation | 1 | 1 | |||||||||
| Dizziness | 1 | 1 | |||||||||
| Total | 11 | 8 | 6 | 2 | 8 | 14 | 3 | 1 | 1 | 4 | 58 |
Serious AEs
A total of 3 serious AEs (requiring inpatient hospitalization) were reported: a cardio‐respiratory arrest during the session and a hip fracture (attributed to a fall) and cholecystitis, both after the session.
Severity of the AEs
Of the AEs, 50% (n = 64) were classified as mild, with mild symptoms, or asymptomatic; 42.2% (n = 54) were classified as moderate with minimal, local, or noninvasive intervention; 7% (n = 9) were classified as severe, limiting self‐care activities of daily living; and 0.8% (n = 1) were graded as a life‐threatening consequence.
Patient/Caregiver Perception of the AE Impact
From the patient/caregiver perspective, 39.8% (n = 51) of AEs had a moderate functional impact, 35.2% (n = 45) had a minor impact, and 9.4% (n = 20) of AEs had no functional impact. Falls, cholecystitis, weakness/tiredness, discomfort/pain, hypotension, and confusion/disorientation were classified as having significant impacts on functional capacity.
Physiotherapist Perception of Causality
The therapists categorized 46.9% (n = 60) of the events as unlikely to be related to the sessions, 38.3% (n = 49) as having a possible causal relationship, and 14.8% (n = 19) as having a certain relationship (Appendix S2).
Discussion
In 1845 sessions held, 128 AEs were reported, confirming previous findings that, despite the lack of reporting, AEs do occur in the field of physiotherapy. 24
Are Physiotherapy Interventions for Patients with Parkinsonian Syndromes Safe?
The findings demonstrate that physiotherapy‐related AEs do occur. The risk of occurrence (7%) is, however, lower than that associated with the pharmacological intervention for the same population (≥10%), suggesting that it is a safe approach.
Physiotherapy is an important therapeutic intervention for this population. Although the quantification of their frequency is important, it is critical to also characterize the events to maximize the sessions' safety and efficacy.
How physiotherapists manage and mitigate AEs is what ensures patient safety during the sessions. A risk‐minimization plan should be designed for each patient based on the patient's assessment, intervention plan, and setting. Strategies such as performing a detailed and accurate assessment of the motor and nonmotor symptoms, having a preventive attitude while performing more challenging exercises, and controlling vital signs through nonpharmacological measures can help minimize risk. Patient and caregiver education is also critical to minimize the risk of AE after the sessions. It is important to remember that patients with advanced age and medical comorbidity are also more likely to have an AE.
Although 2 falls occurred during online sessions, these can be considered a safe treatment option based on our and previous findings 25 as long as they are preceded by a thorough clinical evaluation and a risk‐mitigation plan.
Which Type of AEs Occur More Frequently in Physiotherapy Interventions?
Falls after the sessions were the most frequent AE. They are, however, a symptom of these diseases, and physiotherapy/exercise is a treatment strategy for preventing them. 26 , 27
Pain was the second most common AE. In addition to being a common nonmotor symptom in patients with PD, this may be justified by the physical effort and various movements associated with physiotherapy interventions in patients who are typically sedentary. Hypotension was mostly described during the sessions. Orthostatic hypotension affects one‐third of patients with PD, and it is more frequent among atypical parkinsonisms. 28 During the sessions, patients exercise in a standing position and exert functional activities that require positional changes, which may amplify blood pressure variations.
How to Improve AE Reporting in the Physiotherapy Field
The high number of AEs reported is likely the result of the physiotherapists' increased awareness and use of a high‐sensitivity tool.
The assumption that physiotherapy is a safe intervention (because of the absence of drugs or invasive procedures), physiotherapists' lack of training in reporting AEs, and the lack of a standard reporting tool may be some of the reasons why the AE topic has received insufficient attention in the rehabilitation field. We highlight the importance of increasing physiotherapists' awareness of not only reporting AEs reported by patients or witnessed by the physiotherapist but also documenting the content of each session and actively asking patients how they felt after the session calmly and avoiding a nocebo effect.
Limitation
This study presents 2 major limitations. First, physiotherapy sessions were tailored to the individual and delivered by movement disorder–trained physiotherapists, which is not a common practice in most rehabilitation centers and may contribute to the low frequency and severity of AEs. Second, causality evaluation was hampered, making it impossible to distinguish between physiotherapy‐related and non–physiotherapy‐related events. Despite these limitations, we believe our findings are critical not only for informing future research but also for alerting and guiding physiotherapists in clinical practice and promoting greater attention to safety aspects.
Conclusion
AEs occur during physiotherapy sessions. To our knowledge, this is the first study in the field of movement disorders to investigate this topic. The relationship between AE occurrence and type of intervention as well as causality and risk‐minimization strategies need to be clarified in future research.
Author Roles
(1) Research Project: A. Conception, B. Organization, C. Execution; (2) Statistical Analysis: A. Design, B. Execution, C. Review and Critique; (3) Manuscript Preparation: A. Writing of the First Draft, B. Review and Critique.
V.C.: 1A, 1B, 1C, 2A, 2B, 3A
R.B.‐M.: 1A, 1B, 2A, 2B, 2C, 3B
M.M.R.: 1A, 1B, 2A, 2C, 3B
J.J.F.: 1A, 1B, 2A, 2C, 3B
CNS ‐ Campus Neurológico Physiotherapy Study Group: 1C, 3B
Disclosures
Ethical Compliance Statement: We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. The studies involving human participants were reviewed and approved by the CNS‐ Campus Neurológico Ethics Committee (Reference 07–2020) and the Ethics Committee of the Centro Académico de Medicina de Lisboa and Centro Hospitalar Universitário Lisboa Norte (CHULN e CAML) (Reference 17/20). The patients/participants provided their written informed consent to participate in this study.
Funding Sources and Conflicts of Interest: No specific funding was received for this work. The authors declare that there are no financial disclosures or conflicts of interest relevant to this work.
Financial Disclosures for the Previous 12 Months: Verónica Caniça and Raquel Bouça‐Machado have nothing to disclose. Joaquim J. Ferreira reports the following: consultancies with Ipsen, GlaxoSmithKline, Novartis, Teva, Lundbeck, Solvay, Abbott, BIAL, Merck‐Serono, and Merz; grants from GlaxoSmithKline, Grunenthal, Teva, and Fundação MSD; and employment with the Laboratory of Clinical Pharmacology and Therapeutics of Lisbon. The CNS Physiotherapy Study Group report no additional disclosures. Mário Miguel Rosa is a member of the CNS‐ Campus Neurológico IEC‐ Independent Ethics Committee and reports no additional disclosure.
Supporting information
Appendix S1: Case Report Form.
Appendix S2: Frequency of events by causality and time of occurrence of the adverse event.
Acknowledgments
Following are collaborators of the CNS ‐ Campus Neurológico Physiotherapy Study Group: Daniela Guerreiro, Raquel Nunes, Pedro Nunes, Francisco Queimado, Alexandra Saúde‐Braz, Mariana Leitão, Inês Lousada, Filipa Pona Ferreira, Teresa Lobo, João Belo, Laura Antunes, Joana Alves, Ricardo Cacho, Beatriz Santos, Susana Dias, Alexandra Patriarca, Patrícia Costa, and Ricardo Batalha.
Relevant disclosures and conflicts of interest are listed at the end of this article.
Collaborators of the CNS ‐ Campus Neurológico Physiotherapy Study Group are listed in the Acknowledgments.
Contributor Information
Joaquim J. Ferreira, Email: joaquimjferreira@gmail.com.
CNS Physiotherapy Study Group:
Daniela Guerreiro, Raquel Nunes, Pedro Nunes, Francisco Queimado, Alexandra Saúde‐Braz, Mariana Leitão, Inês Lousada, Filipa Pona Ferreira, Teresa Lobo, João Belo, Laura Antunes, Joana Alves, Ricardo Cacho, Beatriz Santos, Susana Dias, Alexandra Patriarca, Patrícia Costa, and Ricardo Batalha
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Appendix S1: Case Report Form.
Appendix S2: Frequency of events by causality and time of occurrence of the adverse event.