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EMPOWER-PD - A physical therapy intervention to empower the individuals with Parkinson's disease: a study protocol for a feasibility randomized controlled trial.

ABSTRACT: Background:One of the greatest barriers found by physical therapy treating individuals with Parkinson's disease (PD) is the adherence to treatment, associated with the lack of motivation to remain active. Therefore, there is a need to change the look given to physical therapy and for the individual, seeking the centralization of the therapy in their preferences. This study aims to present the EMPOWER-PD, a protocol based on individual preferences and its design for feasibility. Method:A 12-week pilot for a randomized clinical trial will assess the feasibility and preliminary effectiveness of the EMPOWER-PD and make comparisons with conventional physical therapy (CPh). Both protocols consist of mobility and locomotion training, and aim at improving motor and non-motor symptoms through different approaches. The EMPOWER-PD aims to provide a source of motivation and empowerment of health through the self-knowledge of the individual's abilities and limitations, in a protocol that addresses individual preferences. The CPh is based only on physiotherapist decisions, not addressing the individual's preferences or motivation/empowerment. The target recruitment will be 24 PD individuals, between stages I and III of Hoehn and Yahr (HY), who will be recruited from Brazilian Parkinson's disease Rehabilitation Initiative (BPaRkI) with allocation ratio 1:1. A computerized block randomization procedure will be implemented by a blinded researcher with the participants blinded to group assignment. The sessions will be conducted in a group setting, twice a week, during 60 min for 8?weeks, followed by 4?weeks of follow-up. The primary outcomes will be the feasibility data (adherence, recruitment rate, and safety). The secondary outcomes will assess the preliminary efficacy on qualitative assessment about individual's motivation/empowerment and quantitative motor outcomes (Timed Up and Go and Dynamic Gait Index) and non-motor symptoms (6-min walk test and Fatigue Severity Scale). The recommendation to have 6-12 participants per group will be adopted based on the qualitative analysis to the sample size. Discussion:This study will provide important insights about the physical therapy approach in PD individuals. The EMPOWER-PD is innovative because (1) it proposes an intervention that includes an individual-centered approach with motor control principles; (2) it aims to provide a source of motivation and empowerment of health; (3) assesses the individual in a global view considering motor and non-motor symptoms, using both, qualitative and quantitative metrics. Trial registration:RBR-7ZBXQ5.

SUBMITTER: de Oliveira Braga H

PROVIDER: S-EPMC6348670 | biostudies-other | 2019

REPOSITORIES: biostudies-other

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EMPOWER-PD - A physical therapy intervention to empower the individuals with Parkinson's disease: a study protocol for a feasibility randomized controlled trial.

de Oliveira Braga Helena H Gregório Elaine Cristina EC Myra Rafaela Simon RS de Souza Ana Sofia Kauling ASK Kunh Talita Vitorina TV Klug Jessica J de Azevedo Guimarães Adriana Coutinho AC Swarowsky Alessandra A

Pilot and feasibility studies 20190128

<h4>Background</h4>One of the greatest barriers found by physical therapy treating individuals with Parkinson's disease (PD) is the adherence to treatment, associated with the lack of motivation to remain active. Therefore, there is a need to change the look given to physical therapy and for the individual, seeking the centralization of the therapy in their preferences. This study aims to present the EMPOWER-PD, a protocol based on individual preferences and its design for feasibility.<h4>Method ...[more]

PMID: 30705760

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Project description:BackgroundLatino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men.ObjectiveTo address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables.MethodsLatino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization.ResultsThis study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing.ConclusionsWe developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial.Trial registrationClinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570.International registered report identifier (irrid)DERR1-10.2196/23690.

Project description:BACKGROUND:Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity. OBJECTIVE:The primary objective of this randomized controlled trial was to establish the feasibility of a mobile health (mHealth) physical activity exercise app for individuals with VLUs to improve lower leg function. METHODS:In a 6-week study, adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3. Participants were randomized 1:1 to receive evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature. The mHealth Conditioning Activities for Lower Leg Function app also provided automated educational and motivational messages and user reports. Foot movement on the VLU-affected leg was tracked by a Bluetooth-enabled triaxial accelerometer. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the feasibility of reach, adherence, acceptability, implementation, and maintenance. RESULTS:A total of 24 patients were recruited, enrolled, and randomized in the study. Most patients reported difficulty following the protocol for exercising and using the accelerometer and mobile phone and did not use the provider contact feature. However, all patients were adherent to the 6-week exercise program more than 85% of the time for duration, whereas 33% (8/24) of patients adhered more than 85% for the frequency of performing the exercises. Across the three exercise levels, adherence did not differ between the two groups. Confidence limits around the difference in proportions ranged from -0.4 to 0.7. Providers in FOOTFIT+ were inconsistent in checking participant progress reports because of lack of time from competing work commitments. The technology became outdated quickly, making maintenance problematic. Participants said they would continue to exercise their foot and legs and liked being able to follow along with the demonstrations of each level of exercise provided through the app. CONCLUSIONS:The findings of this study suggest that despite initial interest in using the app, several components of the program as originally designed had limited acceptability and feasibility. Future refinements should include the use of more modern technology including smaller wearable accelerometers, mobile phones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features. TRIAL REGISTRATION:ClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695.

Project description:Background:Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population. Methods/design:Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility. Discussion:To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS. Trial registration:NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017.

Project description:BackgroundSocial integration and mental health are vital aspects of healthy aging. However, close to half of Canadians older than 80 years report feeling socially isolated. Research has shown that social isolation leads to increased mortality and morbidity, and various interventions have been studied to alleviate loneliness among older adults. This proposal presents an evaluation of an intervention that provides one-on-one coaching, is intergenerational, provides both educational and socialization experiences, and increases technology literacy of older adults to overcome loneliness.ObjectiveThis paper describes the protocol of a randomized, mixed-methods study that will take place in Ontario, Canada. The purpose of this study is to evaluate if an intergenerational technology literacy program can reduce social isolation and depression in older adults via quantitative and qualitative outcome measures.MethodsThis study is a randomized, mixed-methods, feasibility trial with 2 conditions. Older adults in the intervention condition will receive 1 hour of weekly technological assistance to send an email to a family member, for 8 weeks, with the assistance of a volunteer. Participants in the control condition will not receive any intervention. The primary outcomes are loneliness, measured using the University of California, Los Angeles Loneliness Scale, and depression, measured using the Center for Epidemiologic Studies Depression scale, both of which are measured weekly. Secondary outcomes are quality of life, as assessed using the Older People's Quality of Life-Brief version, and technological literacy, evaluated using the Computer Proficiency Questionnaire-12, both of which will be administered before and after the intervention. Semistructured interviews will be completed before and after the intervention to assess participants' social connectedness, familiarity with technology, and their experience with the intervention. The study will be completed in a long-term care facility in Southwestern Ontario, Canada. Significance was set at P<.05.ResultsThis study was funded in April 2019 and ethical approval was obtained in August 2019. Recruitment for the study started in November 2019. The intervention began in February 2020 but was halted due to the COVID-19 pandemic. The trial will be restarted when safe. As of March 2020, 8 participants were recruited.ConclusionsInformation and communication technology interventions have shown varying results in reducing loneliness and improving mental health among older adults. Few studies have examined the role of one-on-one coaching for older adults in addition to technology education in such interventions. Data from this study may have the potential to provide evidence for other groups to disseminate similar interventions in their respective communities.International registered report identifier (irrid)DERR1-10.2196/23767.

Project description:BACKGROUND:Employees in an office setting are more likely to remain physically inactive. Physical inactivity has become one of the major barriers to overcoming the risk factors for anxiety, depression, coronary heart disease, certain cancers, and type 2 diabetes. Currently, there is a gap in mobile health (mHealth) apps to promote physical activity (PA) for workers in the workplace. Studies on behavior change theories have concluded that health apps generally lack the use of theoretical constructs. OBJECTIVE:The objective of this study was to study the feasibility of a persuasive app aimed at encouraging PA among employees and to understand the motivational aspects behind the implementation of mHealth apps among office workers. METHODS:A 4-week study using a mixed methods (quantitative and qualitative) design was conducted with office-based employees in cities in 4 countries: Oulu, Finland; Carlow, Ireland; London, United Kingdom; and Dhaka, Bangladesh. Of the 220 invited participants (experimental group, n=115; control group, n=105), 84 participated (experimental group, n=56; control group, n=28), consisting of working-age volunteers working in an office setting. Participants used 2 different interventions: The experimental group used an mHealth app for PA motivation, and the control group used a paper diary. The purpose was to motivate employees to engage in healthier behavior regarding the promotion of PA in the workplace. A user-centered design process was followed to design, develop, and evaluate the mHealth app, incorporating self-determination theory (SDT) and using game elements. The paper diary had no specific theory-driven approach, design technique, nor game elements. RESULTS:Compliance with app usage remained relatively low, with 27 participants (experimental group, n=20; control group, n=7) completing the study. The results support the original hypothesis that the mHealth app would help increase PA (ie, promoting daily walking in the workplace) in comparison to a paper diary (P=.033). The mHealth app supported 2 of the basic SDT psychological needs, namely autonomy (P=.004) and competence (P=.014), but not the needs of relatedness (P=.535). CONCLUSIONS:The SDT-based mHealth application motivated employees to increase their PA in the workplace. However, compliance with app usage remained low. Future research should further develop the app based on user feedback and test it in a larger sample.

Project description:BACKGROUND:Youth with disabilities are at high risk of unemployment compared with youth without disabilities. They often encounter challenges in accessing vocational programs that meet their needs. One promising approach that could help to address barriers that youth encounter while also enhancing social support is through electronic mentoring (e-mentoring). Although there is an increase in e-mentoring for youth with disabilities, little is known about its impact for youth with physical disabilities. OBJECTIVE:This study aimed to assess the acceptability and initial impact of a Web-based peer electronic mentor employment intervention for youth with physical disabilities. METHODS:The Empowering Youth Towards Employment intervention was evaluated using a pilot randomized controlled trial (RCT). Youth, aged 15-21 years, with physical disabilities were randomly assigned to an intervention (ie, mentored) or control (ie, not mentored) group. Trained mentors (ie, near peers) with a physical disability led the online discussion forums and provided peer support and resources for 12 modules (1 topic per week over 12 weeks). Primary outcomes focused on self-determination, career maturity, and social support. We also explored program adherence and dosage, participant satisfaction, and areas for improvement. RESULTS:A total of 13 youth (mean age 17.3 years, SD 1.88; 54%, 7/13 female) completed the RCT. In the intervention group (n=9), 56% (5/9) of the youth were females, and in the control group (n=4), 50% (2/4) of the youth were female. Participants reported satisfaction with the program and that it was feasible and acceptable. Participants' mean engagement level with the program was 5.22 (SD 2.48) for the intervention group and 5.40 (SD 4.56) for controls. Participants in the intervention group demonstrated significant improvements in self-determination (t12=2.49; P<.04) compared with the control group. No adverse events were reported. CONCLUSIONS:The Empowering Youth Towards Employment is a promising intervention that enhances self-determination among youth with physical disabilities. TRIAL REGISTRATION:ClinicalTrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/resprot.8034.

Project description:BACKGROUND:Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs. OBJECTIVE:The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs. METHODS:The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants' PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months. RESULTS:Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities. CONCLUSIONS:We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs. TRIAL REGISTRATION:ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/19213.

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EMPOWER-PD - A physical therapy intervention to empower the individuals with Parkinson's disease: a study protocol for a feasibility randomized controlled trial.

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EMPOWER-PD - A physical therapy intervention to empower the individuals with Parkinson's disease: a study protocol for a feasibility randomized controlled trial.

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