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Implementation of the HiBalance training program for Parkinson's disease in clinical settings: A feasibility study.

ABSTRACT: BACKGROUND:Translating evidence into practice requires adaptation to facilitate the implementation of efficacious interventions. A novel highly challenging balance training program (HiBalance) was found to improve gait, balance, and physical activity in persons with Parkinson's disease (PD) in an earlier randomized controlled trial. This study aimed to describe the adaptation process and feasibility of implementing the HiBalance program for PD within primary healthcare settings. METHOD:Feasibility was assessed in terms of study processes and scientific evaluation. Nine persons with mild-moderate PD were enrolled in this pre-post feasibility study. The dose of the original program was adapted by reducing therapist-led training sessions from three to two times weekly. Outcome measures were substituted with ones more clinically feasible. One group (n = 5) received HiBalance training three times weekly for 10 weeks while another (n = 4) trained twice weekly plus a once weekly home exercise program (HEP). Balance performance was the primary outcome, while secondary outcomes (e.g., gait speed, physical activity level, concerns of falling, and health-related quality of life) were also evaluated. RESULTS:Regarding process feasibility, attendance was high (approximately 90%) in both groups, and experiences of the group and home training were positive. Newly selected outcome measures were feasible. The scientific evaluation revealed few adverse events and no serious injuries occurred. Concerning outcomes per group, the average change in balance performance and gait speed was equal to, or exceeded, the minimally worthwhile treatment effect commonly used in PD. CONCLUSION:The findings support the feasibility, in terms of process and scientific evaluation, of the adapted HiBalance program for implementation within clinical settings. A sufficiently powered study is required to ascertain whether the newly proposed program offers similar short and long-term effects as the original program.

SUBMITTER: Joseph C

PROVIDER: S-EPMC6085912 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Implementation of the HiBalance training program for Parkinson's disease in clinical settings: A feasibility study.

Joseph Conran C Leavy Breiffni B Mattsson Sara S Falk Lynn L Franzén Erika E

Brain and behavior 20180621 8

<h4>Background</h4>Translating evidence into practice requires adaptation to facilitate the implementation of efficacious interventions. A novel highly challenging balance training program (HiBalance) was found to improve gait, balance, and physical activity in persons with Parkinson's disease (PD) in an earlier randomized controlled trial. This study aimed to describe the adaptation process and feasibility of implementing the HiBalance program for PD within primary healthcare settings.<h4>Metho ...[more]

PMID: 29931778

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Project description:BackgroundProcess evaluations provide contextual insight into the way in which interventions are delivered. This information is essential when designing strategies to implement programs into wider clinical practice. We performed a process evaluation of the HiBalance effectiveness trial investigating the effects of a 10-week of highly challenging and progressive balance training for mild-moderate Parkinson's disease (PD). Study aims were to investigate i) the quality and quantity of intervention delivery and ii) barriers and facilitators for implementation.MethodsProcess outcomes included; Fidelity; Dose (delivered and received) Recruitment and Reach. Investigation of barriers and facilitators was guided by the Consolidated Framework for Implementation Research. Program delivery was assessed across four neurological rehabilitation sites during a two-year period. Data collection was mixed-methods in nature and quantitative and qualitative data were merged during the analysis phase.ResultsThirteen program trainers delivered the intervention to 12 separate groups during 119 training sessions. Trainer fidelity to program core components was very high in 104 (87%) of the sessions. Participant responsiveness to the core components was generally high, although adherence to the home exercise program was low (50%). No significant context-specific differences were observed across sites in terms of fidelity, dose delivered/ received or participant characteristics, despite varying recruitment methods. Facilitators to program delivery were; PD-specificity, high training frequency and professional autonomy. Perceived barriers included; cognitive impairment, absent reactional balance among participants, as well a heterogeneous group in relation to balance capacity.ConclusionThese findings provide corroborating evidence for outcome evaluation results and valuable information for the further adaptation and implementation of this program. Important lessons can also be learned for researchers and clinicians planning to implement challenging exercise training programs for people with mild-moderate PD.Trial registrationClinicalTrials.gov, NCT02727478 , registered 30 march, 2016 - Retrospectively registered.

Project description:BackgroundParkinson's can impact people's speech, cognition, pragmatics, and language, significantly affecting their conversations with others. The speech and language therapy approach called communication partner training (CPT) is effective for a range of communication difficulties. However, speech and language therapy interventions for people with Parkinson's predominantly focus on impairments, with little provision of CPT for this population. Better Conversations is a CPT approach that involves working with a dyad (the person with the communication difficulty and a conversation partner [CP]) to build conversation skills. It is effective at reducing barriers to conversation, and for some, it significantly increases targeted facilitatory strategies. Some approaches to CPT have been adapted to be delivered via telehealth. This can maximize ecological validity and convenience. Furthermore, telehealth is widely accepted as a delivery method for other interventions for Parkinson's. This study presents the protocol for a pilot feasibility study of a Better Conversations CPT delivered via telehealth to people living with Parkinson's and their CPs, called Better Conversations with Parkinson's (BCP).ObjectiveThe primary aim is to evaluate the feasibility of the BCP program delivered via telehealth with a treatment group from a collaborating National Health Service (NHS) site to establish for a main trial whether BCP can be delivered as intended in an NHS setting. The aim is to establish: (1) the acceptability of the program for people living with Parkinson's, family members, and speech and language therapists (SLTs); (2) the feasibility of delivering the BCP program; (3) the recruitment and retention rates; (4) a sample size calculation; and (5) the most appropriate primary outcome measure.MethodsEthical approval for this study was obtained from London-Central Research Ethics Committee (reference: 22/LO/0332). This case-series feasibility pilot study will recruit 10-12 dyads to ensure 10 complete data sets. Participants will be recruited by a collaborating NHS site located in England. Participants will be involved for 16 weeks (weeks 1-2 preintervention measures, weeks 3-8 intervention, weeks 10-12 postintervention measures, week 16 follow-up interview). Quantitative and qualitative methods will be used to analyze the study data. Speech, communication, and quality of life assessment data will be analyzed statistically to determine a suitably sensitive outcome measure. Descriptive statistics will be used to report on recruitment, attendance, and attrition. Finally, acceptability and feasibility will be evaluated using participant feedback, interviews, and the reflective diary and feedback of the SLT administering the therapy (by the research assistant who is the first author). This data will be analyzed using descriptive statistics and reflexive thematic analysis.ResultsThis study was approved for funding from Parkinson's UK. Study recruitment commenced in July 2022. The results of the data analysis are expected to be available by September 2024.ConclusionsInsights from this study will provide valuable information about the acceptability and feasibility of a remotely delivered Better Conversations CPT approach for people living with Parkinson's and their CPs. An outcome of this study will be a manualized BCP program coproduced by people living with Parkinson's, their families, and a group of expert SLTs. The study results will guide the next stages of intervention development.International registered report identifier (irrid)PRR1-10.2196/41416.

Project description:BackgroundEfficacy of exercise to improve motor symptoms in Parkinson's Disease (PD) has been established in multiple clinical trials. The Pedaling for Parkinson's ™ (PFP) program is an existing community-based cycling intervention for individuals with PD. Although PFP program design was informed by in-laboratory efficacy studies, the implementation and effectiveness of the program in the community have not been studied. This feasibility study explores implementation and effectiveness of PFP utilizing the RE-AIM implementation evaluation framework.MethodsThis was a pragmatic open-label multi-site study. First, community-based gyms were recruited to implement the PFP protocol with enhanced multi-modal training and support. Second individuals with Hoehn and Yahr stage I-III idiopathic PD were recruited to participate. Reach, effectiveness (both clinical scores and participant enjoyment), adoption, implementation (gym and participant fidelity, cost), and maintenance (sustainability) were assessed. Tracking of adverse events was used to monitor safety of the intervention.ResultsReach was moderate: 59% of participants who expressed interest opted to participate. No effectiveness outcomes demonstrated a significant change from pre to post; however, the program was highly enjoyable (96% of participants who started classes enjoyed the program and 87% wished to continue). Adoption was poor with only four out of 34 gyms participating. The program had poor gym and moderate participant fidelity. The program was maintained for at least 4 months across all sites. The program was implemented safely.ConclusionBarriers to implementation of nonpharmacologic interventions such as exercise protocols limit reach and availability of these interventions to patients. Pilot studies are needed to inform and direct further implementation efforts. Our pilot study suggests the PFP cycling intervention should be modified prior to attempts at widespread implementation. Modifications made by gyms in this study suggest adaptations to the protocol that may increase fidelity and effectiveness.

Project description:If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented. The HiBalance program is systemically designed to target balance impairments in PD and has been shown effective at improving balance control and gait in a previous RCT. Study aims are to i) determine the effectiveness of the adapted HiBalance program on performance and self-rated outcomes such as balance control, gait and physical activity level ii) conduct a process evaluation of program implementation at the various clinics iii) determine barriers and facilitators to program implementation in these settings.This effectiveness-implementation type 1 hybrid study will use a non-randomized controlled design with consecutive inclusion of people with PD at multiple clinical sites. A mixed method approach will be used to collect clinical effectiveness data and process evaluation data which is both quantitative and qualitative in nature. The consolidated framework for implementation research (CFIR) will be used to guide the planning and collection of data concerning implementation barriers and facilitators. The HiBalance program will be provided by physical therapists as a part of standard rehabilitation care at the clinical sites, while the evaluation of the implementation process will be performed by the research group and funded by research grants.An effectiveness-implementation study design benefits patients by speeding up the process of translating findings from research settings to routine health care. Findings from this study will also be highly relevant for those working with neurological rehabilitation when faced with decisions concerning the translation of training programs from efficacy studies to everyday clinical practice.ClinicalTrials.gov march 2016, NCT02727478 .

Project description:CONTEXT: Evaluating the translatability and feasibility of an intervention program has become as important as determining the effectiveness of the intervention. OBJECTIVE: To evaluate the applicability of a 3-month jump-landing training program in basketball players, using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. DESIGN: Randomized controlled trial. SETTING: National and regional basketball teams. PATIENTS OR OTHER PARTICIPANTS: Twenty-four teams of the second highest national division and regional basketball divisions in Flanders, Belgium, were randomly assigned (1:1) to a control group and intervention group. A total of 243 athletes (control group = 129, intervention group = 114), ages 15 to 41 years, volunteered. INTERVENTION(S): All exercises in the intervention program followed a progressive development, emphasizing lower extremity alignment during jump-landing activities. MAIN OUTCOME MEASURE(S): The results of the process evaluation of the intervention program were based on the 5 dimensions of the RE-AIM framework. The injury incidence density, hazard ratios, and 95% confidence intervals were determined. RESULTS: The participation rate of the total sample was 100% (reach). The hazard ratio was different between the intervention group and the control group (0.40 [95% confidence interval = 0.16, 0.99]; effectiveness). Of the 12 teams in the intervention group, 8 teams (66.7%) agreed to participate in the study (adoption). Eight of the participating coaches (66.7%) felt positively about the intervention program and stated that they had implemented the training sessions of the program as intended (implementation). All coaches except 1 (87.5%) intended to continue the intervention program the next season (maintenance). CONCLUSIONS: Compliance of the coaches in this coach-supervised jump-landing training program was high. In addition, the program was effective in preventing lower extremity injuries.

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Implementation of the HiBalance training program for Parkinson's disease in clinical settings: A feasibility study.

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Implementation of the HiBalance training program for Parkinson's disease in clinical settings: A feasibility study.

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