Objective To evaluate whether a 4-week multidisciplinary, aerobic, motor-cognitive and intensive rehabilitation treatment (MIRT) improves the quality of life (QoL) of patients with Parkinson’s disease (PD), in the short-term and long-term period.
Methods This is a prospective, parallel-group, single-centre, single-blind, randomised clinical trial (ClinicalTrials.gov NCT02756676). 186 patients with PD, assigned to experimental group, underwent MIRT; conversely, 48 patients, assigned to control group, did not receive rehabilitation. Parkinson’s Disease Questionnaire-39 was assessed 2 (T0), 10 (T1) and 18 (T2, only experimental group) weeks after the enrolment. We compared T1 versus T0 scores within subjects and delta scores (T1–T0) between subjects. To investigate the long-term effects, we compared T2 and T0 scores in the experimental group.
Results At T0, no between-group differences in the Global Index Score (GBI) were observed (experimental group: 43.6±21.4, controls: 41.6±22.9, P=0.50). At T1, we did not find significant changes in controls (delta score: 1.2±9.9, P=0.23), and we found an improvement in GBI in the experimental group (delta score: −8.3±18.0, P<0.0001), significant also between subjects (P<0.0001). Comparing T2 versus T0 in the experimental group, the GBI maintained a significant improvement (delta score: −4.8±17.5, P<0.0001).
Conclusions A rehabilitation treatment such as MIRT could improve QoL in patients with PD in the short-term and long-term period. Even though the single-blind design and the possible role of the placebo effect on the conclusive results must be considered as limitations of this study, the improvement in outcome measure, also maintained after a 3-month follow-up period, suggests the effectiveness of MIRT on the QoL.
Clinical trial registration NCT02756676: Pre-results.
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PO, RM and GF contributed equally.
Contributors DF: wrote the text, conceived and designed the experiments, provided substantial contributions to discussion and edited the manuscript before submission. PO: wrote the text, conceived and designed the experiments, performed the experiments, provided substantial contributions to discussion and generated the figures. IZ: wrote the text, conceived and designed the experiments, and provided substantial contributions to discussion. VC: researched data for the article. EU: researched data for the article. MFG: provided substantial contributions to discussion. RM: analysed the data and did the statistical analysis. GF: conceived and designed the experiments, analysed the data, wrote the text and provided substantial contributions to discussion.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The study design and protocol were approved by the local scientific committee (‘Moriggia-Pelascini’ Hospital, Gravedona e Uniti - Como) and were in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki, 1967).
Provenance and peer review Not commissioned; externally peer reviewed.
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