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Parkinson’s disease (PD) is a complex neurodegenerative disorder characterised by disabling motor and non-motor signs. Current medical therapies can partially alleviate these symptoms, but are also accompanied by dose-limiting side effects. Moreover, their therapeutic window narrows with disease progression, leaving the patient with increasing disability. Complementary non-pharmacological approaches, such as aerobic exercise, have been evaluated for over two decades. The heterogeneity of the interventions and outcomes used hinders the interpretation of the effect of exercise in PD.1 Several systematic reviews and meta-analyses have pooled the results, but their conclusions depend greatly on the diversity of the included exercise modalities. Nevertheless, a beneficial effect of exercise on motor symptoms of PD as well as a general health benefit (physical fitness) seems likely from these studies. A beneficial effect on non-motor symptoms in PD is also conceivable, but not yet proven.2 To strengthen the evidence on symptomatic benefits, we need methodologically sound randomised controlled trials (RCTs) with large sample sizes, clinically relevant outcomes for both motor and non-motor signs, long-term interventions and prolonged follow-up.3 Additionally, there is a need for pragmatic home-based or community-based studies, aiming to test the feasibility and efficacy of exercise therapies in real life. Several semi-supervised home-based studies were performed in PD before. These included low-intensity therapies that were delivered only briefly. 4. Although these home-based studies reported some positive results, it appears that more intensive exercise therapies (ie, resistance or endurance training) provide the greatest benefit. Furthermore, the level of direct supervision in these studies is relatively high and therefore time consuming.
We aim to address these challenges. Our long-term aim is to perform a large RCT in which aerobic exercise (AE) of a moderate intensity is performed at home during 6 months with remote supervision. Before commencing such a large trial, we must first establish the level of adherence of PD patients with a long-term home-based exercise protocol of this intensity. Adherence rates are often based on self-report, which are prone to overestimations, recall bias, social desirability bias and errors in self-observation. Data on adherence from previous home-based exercise studies in PD are scarcea.o 4. This is the first feasibility trial that aims to test adherence in a long-term home-based aerobic exercise trial of moderate intensity, using technological advances to objectively measure adherence and to allow for remote supervision.
Patients and methods
Participants with PD (H&Y 1–2), aged between 30 and 75 years, with a sedentary lifestyle, were recruited at two centres; eligible patients were randomised to either aerobic exercise or no intervention (control). The intervention lasted 6 months, during which participants had to exercise on a stationary home trainer equipped with virtual reality software for 3 times perweek during 30 min within their prescribed heart rate zone. At baseline and at the end of treatment (EOT), the following assessments were performed in the OFF state: Unified Parkinson’s Disease Rating Scale (UPDRS) part III, instrumented timed up and go, postural sway test, quantified finger tapping, a pegboard test, TMT, Scales for Outcomes in Parkinson’s disease (SCOPA) sleep, SCOPA cognition, 39-item Parkinson’s Disease Questionnaire and Hamilton Anxiety and Depression Scale. An incremental exercise test was performed during an ON state to measure the VO2max at baseline and EOT. Assessors were blinded to group allocation. In addition, the LAPAQ outdoor questionnaire was administered in both groups at baseline and at the end of the intervention period to check for differences in physical activity before and after participation. A complete description of patients and methods is given in the supplementary section.
Thirty-seven patients were included (15 control and 22 intervention) (see online supplementary figure S1). Baseline characteristics were similar between both groups (see online supplementary table S1). Two patients dropped out of the intervention group; one patient completed the EOT assessment only partially and the other was lost to follow-up. Participants exercised for a median of 27.4 weeks (IQ1;3: 25.8;28.9), 2.8x/week (IQ1–3: 2.5–3.1) and for 40 min/session (IQ1;3: 34;45). Median time within the prescribed heart rate zone per session was 23 min (IQ1;3: 15;29) and on average patients exercised at 59% (SD 8) of their heart rate reserve (HRR) (ie, 76% of their HRmax). No falls or serious adverse events occurred during the intervention period. Physical fitness improved significantly in the intervention group (+17.6%) at EOT (table 1).
Overall, adherence to the intervention was excellent (drop-out rate 5.4%; exercise adherence 92%). Both are better than findings in previous home-based exercise trials in PD (drop-out rates 10%–25%, exercise adherence rates 70%–87%).4 4. These studies had poorer compliance, although they tested shorter interventions with lower intensities. This underlines the feasibility of our more intensive intervention in real life. We used technological advances to directly store and share training data, allowing for an objective measurement of the performed exercise with remote supervision. This telemonitoring not only increased safety but also offered support and motivation (because patients knew that someone was following their results). We suspect that this blended combination of human support and technology jointly contributed to the excellent adherence here.
The intervention group showed a significant improvement in physical fitness, which is similar to other AE studies in PD.1 This shows that patients received an adequate aerobic stimulus via the performed exercise. The lack of significant improvements in motor and non-motor outcomes was not unexpected since our primary goal was to test feasibility and, particularly, to assess compliance, but not necessarily the effectiveness of a specific aerobic exercise protocol. It was encouraging that we did observe a positive (although not significant) impact of the present intervention on the UPDRS motor score (a clinically relevant outcome measure), and that the observed effect size (median difference in favour of exercise: 3.1 points) was within the range of a clinically important difference. Previous home-based exercise trials in PD also reported some positive results, but the differences in interventions (modality, intensity and duration) and outcomes used make it difficult to directly compare these studies with ours. Additional large home-based aerobic exercise RCTs are needed, and currently ongoing,5 in order to establish efficacy of this intervention on the UPDRS motor score and other clinically relevant outcome measures.
In conclusion, this study indicates that patients with PD can safely perform and reliably comply with a moderately intensive AE at home for 6 months with limited supervision.
We thank Casper Reijnen, Jasmijn Hebbink and Edith Janssen for their contribution in the study.
Contributors NK participated in the design, enrolled patients, carried out and coordinated the study at the Nijmegen site and drafted the manuscript. NV and BP helped draft the manuscript. AP enrolled patients and coordinated the study at the Cleveland site. MN participated in the design and coordination of the study and helped draft the manuscript. MV and AM participated in the cardiopulmonary screening before physical fitness testing of the patients at the Nijmegen site. BB and JA wrote the grant application, conceived of the study and participated in its design and coordination and helped draft the manuscript. All authors read and approved the final manuscript.
Competing interests None declared.
Patient consent Obtained.
Ethics approval CMO Arnhem-Nijmegen and Cleveland Clinic Institutional Review Board.
Provenance and peer review Not commissioned; externally peer reviewed.
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