Exploring outcome measures for exercise intervention in people with Parkinson's disease.
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ABSTRACT:
SUBMITTER: King LA
PROVIDER: S-EPMC3657411 | biostudies-literature | 2013
REPOSITORIES: biostudies-literature
Publications
Exploring outcome measures for exercise intervention in people with Parkinson's disease.
King L A LA Salarian A A Mancini M M Priest K C KC Nutt J J Serdar A A Wilhelm J J Schlimgen J J Smith M M Horak F B FB
Parkinson's disease 20130430
Background. It is widely believed that exercise improves mobility in people with Parkinson's disease (PD). However, it is difficult to determine whether a specific type of exercise is the most effective. The purpose of this study was to determine which outcome measures were sensitive to exercise intervention and to explore the effects of two different exercise programs for improving mobility in patients with PD. Methods. Participants were randomized into either the Agility Boot Camp (ABC) or tre ...[more]
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Project description:Introduction: The satisfactory symptomatic control of the axial symptoms of Parkinson's disease (PD) remains challenging. As these symptoms are an important cause of disability, new therapeutic strategies should be developed and evaluated. To do this, it is necessary to select the outcomes to be measured and reported in a clinical trial. In this study, we sought to identify the most responsive outcome measures for assessing the efficacy of a multidisciplinary intervention on the axial symptoms of PD. Methods: An exploratory prospective clinical study was conducted. PD patients engaged in a pre-defined multidisciplinary intervention program for parkinsonian patients were assessed at admission and discharge by a multidisciplinary team. The responsiveness to intervention was evaluated and the smallest sample size needed to enable statistically significant results for an expected 30% change from baseline for each outcome was calculated. Results: Twenty-two patients were included in the study. The effect size detected varied between 0.04 and 0.83. The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score and each subsection, the N-FOG questionnaire, the 10-m walk test, and Frenchay Dysarthria Assessment-2 Edition (FDA-2) showed a medium to large effect size. Sample size calculations for 90% power and assuming 30% change from baseline ranged from eight to 180 participants. The outcome measures that require a small number of participants to enable statistically significant results were the FDA-2 rating scale (n = 4 participants), the MDS-UPDRS total score (n = 9), the 10-m walk test (n = 9), and the MDS-UPDRS motor examination (n = 10). Conclusions: The MDS-UPDRS part III and total score and the 10-m walk test were the outcomes with the best responsiveness to a multidisciplinary intervention and required a small number of participants to enable statistically significant results. Further studies are needed to clarify the suitability of the Timed Up and Go test.
| S-EPMC7235279 | biostudies-literature
Project description:Parkinson's disease (PD) is a progressive neurological disorder characterized by motor and non-motor symptoms for which only symptomatic treatments exist. Exercise is a widely studied complementary treatment option. Aerobic exercise, defined as continuous movement of the body's large muscles in a rhythmic manner for a sustained period that increases caloric requirements and aims at maintaining or improving physical fitness, appears promising. We performed both a scoping review and a systematic review on the generic and disease-specific health benefits of aerobic exercise for people with PD. We support this by a meta-analysis on the effects on physical fitness (VO2max), motor symptoms (Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor section), and health-related quality of life (39-item Parkinson's disease Questionnaire (PDQ-39)). Aerobic exercise has generic health benefits for people with PD, including a reduced incidence of cardiovascular disease, a lower mortality, and an improved bone health. Additionally, there is level 1 evidence that aerobic exercise improves physical fitness (VO2max) and attenuates motor symptoms (MDS-UPDRS motor section) in the off-medication state, although the long-term effects (beyond 6 months) remain unclear. Dosing the exercise matters: improvements appear to be greater after training at higher intensities compared with moderate intensities. We found insufficient evidence for a beneficial effect of aerobic exercise on health-related quality of life (PDQ-39) and conflicting results regarding non-motor symptoms. Compliance to exercise regimes is challenging for PD patients but may be improved by adding exergaming elements to the training program. Aerobic exercise seems a safe intervention for people with PD, although care must be taken to avoid falls in at-risk individuals. Further studies are needed to establish the long term of aerobic exercise, including a focus on non-motor symptoms and health-related quality of life.
| S-EPMC7851311 | biostudies-literature
Project description:Background:Long-term benefits of exercise for people with Parkinson's disease (PD) require regular and sustained participation. This study aimed to investigate predictors of adherence to a minimally supervised exercise program designed to reduce falls in people with PD. Method:People with idiopathic PD who participated in the exercise arm of a randomized, controlled trial were included. Exercises were prescribed three times per week for 6 months. Adherence was defined as the percentage of prescribed sessions participants reported as having undertaken. Potential predictors of adherence included baseline measures of demographic variables, disease severity and duration, falls and fear of falling, pain, self-reported health and quality of life, cognition, physical activity levels, freezing of gait, functional mobility and balance, and knee extensor strength. Results:The 108 participants included undertook a mean of 72% (standard deviation: 38%) of prescribed sessions. Participants had higher levels of adherence if they had shorter disease duration, less bodily pain, and better self-reported health and quality of life. A multivariate model (including disease duration, severity of bodily pain, self-reported physical well-being, the Frontal Assessment Battery, the Short Physical Performance Battery, and maximum walking time) explained 9% of the variance in exercise adherence, with shorter disease duration and less pain the strongest predictors (both predictors standardized ? = -0.2; P = 0.04). Conclusion:Disease duration and pain are likely to negatively influence exercise participation in people with PD. Given that most of the variance in adherence is unexplained, further work is required to determine other predictors of adherence to long-term exercise programs.
| S-EPMC6178659 | biostudies-other
Project description:We previously showed that dual-task cost (DTC) on gait speed in people with Parkinson's disease (PD) improved after 6 weeks of the Agility Boot Camp with Cognitive Challenge (ABC-C) exercise program. Since deficits in dual-task gait speed are associated with freezing of gait and gray matter atrophy, here we performed preplanned secondary analyses to answer two questions: (a) Do people with PD who are freezers present similar improvements compared to nonfreezers in DTC on gait speed with ABC-C? (b) Can cortical thickness at baseline predict responsiveness to the ABC-C? The DTC from 39 freezers and 43 nonfreezers who completed 6 weeks of ABC-C were analyzed. A subset of 51 participants (21 freezers and 30 nonfreezers) with high quality imaging data were used to characterize relationships between baseline cortical thickness and delta (Δ) DTC on gait speed following ABC-C. Freezers showed larger ΔDTC on gait speed than nonfreezers with ABC-C program (p < .05). Cortical thickness in visual and fronto-parietal areas predicted ΔDTC on gait speed in freezers, whereas sensorimotor-lateral thickness predicted ΔDTC on gait speed in nonfreezers (p < .05). When matched for motor severity, visual cortical thickness was a common predictor of response to exercise in all individuals, presenting the largest effect size. In conclusion, freezers improved gait automaticity even more than nonfreezers from cognitively challenging exercise. DTC on gait speed improvement was associated with larger baseline cortical thickness from different brain areas, depending on freezing status, but visual cortex thickness showed the most robust relationship with exercise-induced improvements in DTC.
| S-EPMC7721225 | biostudies-literature
Project description:There is an increasing need for improved endpoints to assess clinical trial effects in Parkinson's disease. We propose the Parkinson's Disease Comprehensive Response as a novel weighted composite endpoint integrating changes measured in three established Parkinson's outcomes, including: OFF state Movement Disorder Society Unified Parkinson's Disease Rating Scale Motor Examination scores; Motor Experiences of Daily Living scores; and total good-quality ON time per day. The data source for the initial development of the composite described herein was a recent Phase II trial of glial cell line-derived neurotrophic factor. A wide range of clinically derived relative weights was assessed to normalize for differentially scoring base rates with each endpoint component. The Parkinson's disease comprehensive response, in contrast to examining practically defined OFF state Unified Parkinson's Disease Rating Scale Motor Examination scores alone, showed stability over 40 weeks in placebo patients, and all 432 analyses in this permutation exercise yielded significant differences in favour of glial cell line-derived neurotrophic factor. The findings were consistent with results obtained employing three different global statistical test methodologies and with patterns of intra-patient change. Based on our detailed analyses, we conclude it worth prospectively evaluating the clinical utility, validity and regulatory feasibility of using clinically supported final Parkinson's disease comprehensive response formulas (for both the Unified Parkinson's Disease Rating Scale-based and Movement Disorders Society-Unified Parkinson's Disease Rating Scale-based versions) in future disease-modifying Parkinson's trials. Whilst the data source employed in the initial development of this weighted composite score is from a recent Phase II trial of glial cell line-derived neurotrophic factor, we wish to stress that the results are not described to provide post hoc evidence of the efficacy of glial cell line-derived neurotrophic factor but rather are presented to further the debate of how current regulatory approved rating scales may be combined to address some of the recognized limitations of using individual scales in isolation.
| S-EPMC7759656 | biostudies-literature
Project description:We sought to investigate whether regular balance training of moderate intensity (BT) has an effect on changes in selected cytokines, neurotrophic factors, CD200 and fractalkine in healthy older adults and participants with Parkinson's disease (PD). Sixty-two subjects were divided into groups depending on experimental intervention: (1) group of people with PD participating in BT (PDBT), (2) group of healthy older people participating in BT (HBT), (3,4) control groups including healthy individuals (HNT) and people with PD (PDNT). Blood samples were collected twice: before and after 12 weeks of balance exercise (PDBT, HBT), or 12 weeks apart (PDNT, HNT). The study revealed significant increase of interleukin10 (PDBT, p = 0.026; HBT, p = 0.011), ?-nerve growth factor (HBT, p = 0.002; PDBT, p = 0.016), transforming growth factor-?1 (PDBT, p = 0.018; HBT, p < 0.004), brain-derived neurotrophic factor (PDBT, p = 0.011; HBT, p < 0.001) and fractalkine (PDBT, p = 0.045; HBT, p < 0.003) concentration only in training groups. In PDBT, we have found a significant decrease of tumor necrosis factor alpha. No training effect on concentration of interleukin6, insulin-like growth factor 1 and CD200 was observed in both training and control groups. Regular training can modulate level of inflammatory markers and induce neuroprotective mechanism to reduce the inflammatory response.
| S-EPMC7019419 | biostudies-literature
Project description:BackgroundRecent studies indicate that exercise can induce neuroplastic changes in people with Parkinson's disease (PwPD). Reports of feasibility outcomes from existing pilot trials however are, of date, insufficient to enable replication by others in larger definitive trials.ObjectiveTo evaluate trial design for a definitive trial by exploring process and scientific feasibility.MethodsThe trial design was a parallel-group RCT pilot with a 1 : 1 allocation ratio to either HiBalance or an active control group (HiCommunication). Both groups received one-hour sessions twice weekly, plus home exercises weekly, for 10 weeks. Participants with mild-to-moderate Parkinson's disease (PD) were recruited via advertisement. Assessment included physical performance, structural and functional MRI, blood sampling, neuropsychological assessment, and speech/voice assessment. Process and scientific feasibility were monitored throughout the study. Process feasibility involved recruitment, participant acceptability of assessments and interventions, assessment procedures (focus on imaging, blood sampling, and dual-task gait analysis), and blinding procedures. Scientific feasibility involved trends in outcome response and safety during group training and home exercises. Data are presented in median, minimum, and maximum values. Changes from pre- to postintervention are reported descriptively.ResultsThirteen participants were included (4 women, mean age 69.7 years), with a recruitment rate of 31%. Attendance rates and follow-up questionnaires indicated that both groups were acceptable to participate. Image quality was acceptable; however, diplopia and/or sleepiness were observed in several participants during MRI. With regard to dual-task gait performance, there appeared to be a ceiling effect of the cognitive tasks with seven participants scoring all correct answers at pretest. Blinding of group allocation was successful for one assessor but was broken for half of participants for the other.ConclusionsThe overall trial design proved feasible to perform, but further strengthening ahead of the definitive RCT is recommended, specifically with respect to MRI setup, cognitive dual-tasks during gait, and blinding procedures. This trial is registered with NCT03213873.
| S-EPMC7132585 | biostudies-literature
Project description:BackgroundParkinson's disease (PD) affects many physiological systems essential for balance control. Recent studies suggest that intensive and cognitively demanding physical exercise programs are capable of inducing plastic brain changes in PD. We have developed a highly challenging balance training (the HiBalance) program that emphasizes critical aspects of balance control through progressively introducing more challenging exercises which incorporates dual-tasking. Earlier studies have shown it to be effective in improving balance, gait and dual-tasking. The study design has thereafter been adjusted to link intervention-induced behavioral changes to brain morphology and function. Specifically, in this randomized controlled trial, we will determine the effects of the HiBalance program on balance, gait and cognition and relate this to task-evoked functional MRI (fMRI), as well as brain-derived neurotrophic factor (BDNF) in participants with mild-moderate PD.MethodsOne hundred participants with idiopathic PD, Hoehn & Yahr stage 2 or 3, ≥ 60 years of age, ≥ 21 on Montreal Cognitive Assessment will be recruited in successive waves and randomized into either the HiBalance program or to an active control group (the HiCommunication program, targeting speech and communication). Both interventions will be performed in small groups, twice a week with 1 h sessions for 10 weeks. In addition, a 1 h, once a week, home exercise program will also be performed. A double-blinded design will be used. At the pre- and post-assessments, participants will be assessed on balance (main outcome), gait, cognitive functions, physical activity, voice/speech function, BDNF in serum and fMRI (3 T Philips) during performance of motor-cognitive tasks.DiscussionSince there is currently no cure for PD, findings of neuroplastic brain changes in response to exercise would revolutionize the way we treat PD, and, in turn, provide new hope to patients for a life with better health, greater independence and improved quality of life.Trial registrationClincalTrials.gov: NCT03213873, first posted July 11, 2017.
| S-EPMC6849188 | biostudies-literature
Project description:Background: Balance deficits in people with Parkinson's disease (PD) are often not helped by pharmacological or surgical treatment. Although balance exercise intervention has been shown to improve clinical measures of balance, the efficacy of exercise on different, objective balance domains is still unknown. Objective: To compare the sensitivity to change in objective and clinical measures of several different domains of balance and gait following an Agility Boot Camp with Cognitive Challenges (ABC-C) intervention. Methods: In this cross-over, randomized design, 86 individuals with PD participated in 6-week (3×/week) ABC-C exercise classes and 6-week education classes, consisting of 3-6 individuals. Blinded examiners tested people in their practical off state. Objective outcome measures from wearable sensors quantified four domains of balance: sway in standing balance, anticipatory postural adjustments (APAs) during step initiation, postural responses to the push-and-release test, and a 2-min natural speed walk with and without a cognitive task. Clinical outcome measures included the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, the Mini Balance Evaluation Systems Test (Mini-BESTest), the Activities of Balance Confidence (ABC), and the Parkinson's Disease Questionnaire (PDQ-39). The standardized response means (SRM) of the differences between before and after each intervention compared responsiveness of outcomes to intervention. A linear mixed model compared effects of exercise with the active control-education intervention. Results: The most responsive outcome measures to exercise intervention with an SRM > 0.5 were objective measures of gait and APAs, specifically arm range of motion, gait speed during a dual-task walk, trunk coronal range of motion, foot strike angle, and first-step length at step initiation. The most responsive clinical outcome measure was the patient-reported PDQ-39 activities daily living subscore, but all clinical measures had SRMs <0.5. Conclusions: The objective measures were more sensitive to change after exercise intervention compared to the clinical measures. Spatiotemporal parameters of gait, including gait speed with a dual task, and APAs were the most sensitive objective measures, and perceived functional independence was the most sensitive clinical measure to change after the ABC-C exercise intervention. Future exercise intervention to improve gait and balance in PD should include objective outcome measures.
| S-EPMC7545952 | biostudies-literature
Project description:Background:There is longstanding controversy surrounding the possible link between essential tremor (ET) and Parkinson's disease (PD). Inconsistent and unreliable diagnostic criteria may in part account for some of the difficulties in defining the relationship between these two common movement disorders. Methods:References for this systematic review were identified using PubMed with the search terms "essential tremor" AND "Parkinson's disease" with articles published in English between 1960 and September 2018 included. Results:In this review we provide evidence that some patients diagnosed with ET have an increased risk of developing PD years or decades after onset of action tremor. There are several still unresolved questions about the link between the two disorders including lack of verifiable diagnostic criteria for the two disorders and marked overlap in phenomenology. Here we review clinical, epidemiologic, imaging, pathologic, and genetic studies that address the ET-PD relationship. Several lines of evidence support the association between ET and PD, including overlapping motor and non-motor features, relatively high prevalence of rapid eye movement sleep behavior disorder (26-43%) in ET patients, increased prevalence of PD in patients with longstanding antecedent ET, increased prevalence of ET in family members of patients with PD, and the presence of Lewy bodies in the brains of some ET patients (15-24%). Discussion:There is a substantial body of evidence supporting the association between ET and PD within at least a subset of patients, although the nature and possible pathogenic mechanisms of the relationship are not well understood.
| S-EPMC6329774 | biostudies-other