Personalized multicomponent exercise programs using smartphone technology among older people: protocol for a randomized controlled trial
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ABSTRACT: Background
Optimal application of the recently updated World Health Organization (WHO) guidelines for exercise in advanced age necessitates an accurate adjustment for the age-related increasing variability in biological age and fitness levels, alongside detailed recommendations across a range of motor fitness components, including balance, strength, and flexibility. We previously developed and validated a novel tool, designed to both remotely assess these fitness components, and subsequently deliver a personalized exercise program via smartphone.
SUBMITTER: Netz Y
PROVIDER: S-EPMC8547559 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundExercise has various health benefits for people with Parkinson's disease (PD). However, implementing exercise into daily life and long-term adherence remain challenging. To increase a sustainable engagement with physical activity of people with PD, interventions that are motivating, accessible, and scalable are needed. We primarily aim to investigate whether a smartphone app (STEPWISE app) can increase physical activity (i.e., step count) in people with PD over one year. Our second aim is to investigate the potential effects of the intervention on physical fitness, and motor- and non-motor function. Our third aim is to explore whether there is a dose-response relationship between volume of physical activity and our secondary endpoints.MethodsSTEPWISE is a double-blind, randomized controlled trial. We aim to include 452 Dutch people with PD who can walk independently (Hoehn & Yahr stages 1-3) and who do not take more than 7,000 steps per day prior to inclusion. Physical activity levels are measured as step counts on the participant's own smartphone and scaled as percentage of each participant's baseline. Participants are randomly assigned to an active control group with an increase of 5-20% (active controls) or any of the three intervention arms with increases of 25-100% (intermediate dose), 50-200% (large dose), or 100-400% (very large dose). The primary endpoint is change in step count as measured by the STEPWISE smartphone app from baseline to 52 weeks. For our primary aim, we will evaluate the between-group difference in average daily step count change from baseline to 52 weeks. For our second aim, measures of physical fitness, and motor- and non-motor function are included. For our third aim, we will associate 52-week changes in step count with 52-week changes in secondary outcomes.DiscussionThis trial evaluates the potential of a smartphone-based intervention to increase activity levels in people with PD. We envision that motivational apps will increase adherence to physical activity recommendations and could permit conduct of remote clinical trials of exercise for people with PD or those at risk of PD.Trial registrationClinicalTrials.gov; NCT04848077; 19/04/2021.Clinicaltrialsgov/ct2/show/NCT04848077.
| S-EPMC10496249 | biostudies-literature
Project description:BackgroundTo examine the effect of multicomponent exercise program on memory function in older adults with mild cognitive impairment (MCI), and identify biomarkers associated with improvement of cognitive functions.Methodology/principal findingsSubjects were 100 older adults (mean age, 75 years) with MCI. The subjects were classified to an amnestic MCI group (n = 50) with neuroimaging measures, and other MCI group (n = 50) before the randomization. Subjects in each group were randomized to either a multicomponent exercise or an education control group using a ratio of 1∶1. The exercise group exercised for 90 min/d, 2 d/wk, 40 times for 6 months. The exercise program was conducted under multitask conditions to stimulate attention and memory. The control group attended two education classes. A repeated-measures ANOVA revealed that no group × time interactions on the cognitive tests and brain atrophy in MCI patients. A sub-analysis of amnestic MCI patients for group × time interactions revealed that the exercise group exhibited significantly better Mini-Mental State Examination (p = .04) and logical memory scores (p = .04), and reducing whole brain cortical atrophy (p<.05) compared to the control group. Low total cholesterol levels before the intervention were associated with an improvement of logical memory scores (p<.05), and a higher level of brain-derived neurotrophic factor was significantly related to improved ADAS-cog scores (p<.05).Conclusions/significanceThe results suggested that an exercise intervention is beneficial for improving logical memory and maintaining general cognitive function and reducing whole brain cortical atrophy in older adults with amnestic MCI. Low total cholesterol and higher brain-derived neurotrophic factor may predict improvement of cognitive functions in older adults with MCI. Further studies are required to determine the positive effects of exercise on cognitive function in older adults with MCI.Trial registrationUMIN-CTR UMIN000003662 ctr.cgi?function = brows&action = brows&type = summary&recptno = R000004436&language = J.
| S-EPMC3621765 | biostudies-literature
Project description:BACKGROUND:Creating inclusive and accessible outdoor environments that provide and encourage opportunities for older adults to engage in physical activity and social interaction is important for healthy ageing. The Senior Exercise Park is outdoor exercise equipment designed specifically for use by older people that provides physical and social benefits for older people in the community, and has the potential to be used widely as a sustainable mode of physical activity. The aim of this study is to implement and evaluate the effects of sustained engagement through the use of a community-based novel outdoor physical activity program (purpose-built exercise park) for older people on physical, mental and social health and physical activity outcomes (the ENJOY project). METHODS:This is a prospective pre-post design study with 12 months follow up. Adults aged ≥60 years will be recruited from the general community from the suburbs close to the Senior Exercise Parks locations in Melbourne. Participants will undergo a 12 week structured supervised physical activity program using the outdoor Senior Exercise Park equipment followed by 6 months unstructured physical activity program. Participants will be assessed at baseline, 3, 9, and 12 months. The following outcomes will be assessed: physical activity, physical function, psychosocial and mental health outcomes, falls risk and falls occurrence, participants' feedback and satisfaction, and health care resource use. DISCUSSION:The ENJOY trial is designed to operate in a community setting with local government engagement to maximise the usage of the exercise park and provide an outdoor space for older people to be physically active. This project will evaluate the effectiveness and sustainability of the outdoor exercise park on a range of health outcomes and its long-term usability in the community. TRIAL REGISTRATION:This trial is prospectively registered with the Australian New Zealand Clinical Trials Registry. Trial registration number ACTRN12618001727235 registered 18th of October 2018.
| S-EPMC6624877 | biostudies-other
Project description:BackgroundWith the advent of antiretrovirals, people living with HIV are living near-normal lifespans. However, people living with HIV are at greater risk of experiencing cognitive impairment and reduced brain integrity despite well-controlled viremia. A robust literature supports exercise interventions as a method of improving cognition and structural brain integrity in older individuals without HIV. The effects of exercise on cardiometabolic, neurocognitive, and neural structures in middle-aged to older people living with HIV are less well known, with few prospective studies examining these measures.ObjectiveThis prospective randomized clinical trial will examine the effects of a 6-month exercise training intervention compared to a 6-month stretching intervention (control) on cardiorespiratory fitness, physical function and strength, cognition, and neuroimaging measures of brain volumes and cerebral blood flow in people living with HIV.MethodsSedentary middle-aged to older people living with HIV (ages≥40; n=150) with undetectable HIV viral load (<20 copies/mL) will be enrolled in the study. At the baseline and final visit, fasting plasma lipid, insulin, glucose, and brain neurotrophic factor concentrations; cardiorespiratory fitness; cognitive performance; brain volumes; and cerebral blood flow via a magnetic resonance imaging scan will be measured. Participants will be randomized in a 2:1 ratio to either the exercise or control stretching intervention. All participants will complete their assigned programs at a community fitness center 3 times a week for 6 months. A professional fitness trainer will provide personal training guidance at all sessions for individuals enrolled in both arms. Individuals randomized to the exercise intervention will perform endurance and strength training exercises, while those randomized to the control intervention will perform stretches to increase flexibility. A midpoint visit (at 3 months) will assess cognitive performance, and at the end point visit, subjects will undergo cardiorespiratory fitness and cognition testing, and a magnetic resonance imaging scan. Physical activity throughout the duration of the trial will be recorded using an actigraph.ResultsRecruitment and data collection are complete as of December 2020. Data processing, cleaning, and organization are complete as of December 2021. Data analysis began in January 2022, with the publication of study results for primary aims 1 and 2 expected by early 2023.ConclusionsThis study will investigate the effects of a 6-month aerobic and resistance exercise training intervention to improve cardiometabolic risk factors, cognitive performance, cerebral structure, and blood flow in sedentary people living with HIV. Results will inform clinicians and patients of the potential benefits of a structured aerobic exercise training program on the cognitive, functional, and cardiometabolic health status of older people living with HIV. Assessment of compliance will inform the development and implementation of future exercise programs for people living with HIV.Trial registrationClinicalTrials.gov NCT02663934; https://clinicaltrials.gov/ct2/show/NCT02663934.International registered report identifier (irrid)DERR1-10.2196/41421.
| S-EPMC10131751 | biostudies-literature
Project description:BackgroundAlthough it is well known that regular physical activity and exercise, as well as maintaining adequate nutritional status is important to delaying symptom development and maintaining physical capacity and function in people with Parkinson's Disease (PD), many are unable to follow self-management recommendations. Active interventions have shown short-term effects, but there is a need for interventions that facilitate self-management over the course of the disease. Until now, no studies have combined exercise and nutritional interventions with an individual self-management approach in PD. Thus, we aim to examine the effect of a six-month mobile health technology(m-health)-based follow-up programme, focusing on self-management in exercise and nutrition, after an in-service interdisciplinary rehabilitation programme.MethodsA single-blinded, two-group randomised controlled trial. Participants are Adults aged 40 or older, with idiopathic PD, Hoehn and Yahr 1-3, living at home. The intervention group receives a monthly, individualized, digital conversation with a PT, combined with use of an activity tracker. People at nutritional risk get additional digital-follow-up from a nutritional specialist. The control group receives usual care. The primary outcome is physical capacity, measured by 6-min walk test (6MWT). Secondary outcomes are nutritional status, Health related quality of life (HRQOL), physical function and exercise adherence. All measurements are performed at baseline, after 3 months and after 6 months. Sample size, based on primary outcome, is set at 100 participants randomized into the two arms, including an estimated 20% drop out.DiscussionThe increasing prevalence of PD globally makes it even more important to develop evidence-based interventions that can increase motivation to stay active, promote adequate nutritional status and improve self-management in people with PD. The individually tailored digital follow-up programme, based on evidence-based practice, has the potential to promote evidence-based decision-making and to empower people with PD to implement exercise and optimal nutrition in their daily lives and, hopefully, increase adherence to exercise and nutritional recommendations.Trial registrationClinicalTrials.gov (NCT04945876). First registration 01.03.2021.
| S-EPMC9979434 | biostudies-literature
Project description:IntroductionFalls have major implications for quality of life, independence and cost to the health service. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. Health services are often unable to deliver the evidence-based dose of exercise and older adults do not always sufficiently adhere to their programme to gain full outcomes. Smartphone technology based on behaviour-change theory has been used to support healthy lifestyles, but not falls prevention exercise. This feasibility trial will explore whether smartphone technology can support patients to better adhere to an evidence-based rehabilitation programme and test study procedures/outcome measures.Methods and analysisA two-arm, pragmatic feasibility randomised controlled trial will be conducted with health services in Manchester, UK. Seventy-two patients aged 50+years eligible for a falls rehabilitation exercise programme from two community services will receive: (1) standard service with a smartphone for outcome measurement only or (2) standard service plus a smartphone including the motivational smartphone app. The primary outcome is feasibility of the intervention, study design and procedures. The secondary outcome is to compare standard outcome measures for falls, function and adherence to instrumented versions collected using smartphone. Outcome measures collected include balance, function, falls, strength, fear of falling, health-related quality of life, resource use and adherence. Outcomes are measured at baseline, 3 and 6-month post-randomisation. Interviews/focus groups with health professionals and participants further explore feasibility of the technology and trial procedures. Primarily analyses will be descriptive.Ethics and disseminationThe study protocol is approved by North West Greater Manchester East Research Ethics Committee (Rec ref:18/NW/0457, 9/07/2018). User groups and patient representatives were consulted to inform trial design, and are involved in study recruitment. Results will be reported at conferences and in peer-reviewed publications. A dissemination event will be held in Manchester to present the results of the trial. The protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.Trial registration numberISRCTN12830220; Pre-results.
| S-EPMC6756425 | biostudies-literature
Project description:Although physical exercise has been suggested to influence cognitive function, previous exercise studies show inconsistent results in people with dementia.To investigate effects of exercise on cognitive function in people with dementia.The Umeå Dementia and Exercise (UMDEX) study, a cluster-randomized controlled trial, was set in 16 nursing homes in Umeå, Sweden. One hundred-and-forty-one women and 45 men with dementia; mean age of 85 y and mean Mini-Mental State Examination (MMSE) score of 15, were randomized to a High-Intensity Functional Exercise program or a seated attention control activity. Blinded assessors measured global cognitive function using the MMSE and the Alzheimer's disease Assessment Scale - Cognitive subscale (ADAS-Cog), and executive function using Verbal fluency (VF) at baseline and 4 months (directly after intervention completion), and MMSE and VF at 7 months.Linear mixed models showed no between-group effects in mean difference from baseline (95% confidence intervals, CI) at 4 months in MMSE (-0.27; 95% CI -1.4 to 0.87, p?=?0.644), ADAS-Cog (-1.04, 95% CI -4 to 1.92, p?=?0.491), or VF (-0.53, 95% CI -1.42 to 0.35, p?=?0.241) or at 7 months in MMSE (-1.15, 95% CI -2.32 to 0.03, p?=?0.056) or VF (-0.18, 95% CI -1.09 to 0.74, p?=?0.707).A 4-month, high-intensity functional exercise program had no superior effects on global cognition or executive function in people with dementia living in nursing homes when compared with an attention control activity.
| S-EPMC5611799 | biostudies-other
Project description:The purpose of this study was to analyze and compare the effects of various muscle strength sessions performed during 10 weeks physical conditioning programs and 4 weeks of detraining on the physical conditioning, body composition and hematology of elderly women. 48 women were randomly distributed in four groups: a physical conditioning group (PCG; n = 12) with two sessions per week; a PCG with an extra-session focus on hypertrophy (PCGH; n = 12), a PCG with an extra-session in a shallow pool (PCGP; n = 12); and a control group (CG; n = 12). PCGH achieved a significant increase in Abalakov. Significant differences between the CG and the other groups were found in Countermovement Jump. There were significant improvements in the chair-stand test in the PCG and PCGH. The training programs suspected improvements in HDL, LDL, baseline glucose and glycated hemoglobin. In conclusion, a training program with an extra-session focus on hypertrophy achieved a greater improvement in strength in elderly women.
| S-EPMC7235353 | biostudies-literature
Project description:BackgroundSiFAr-Stress investigates the impact of cycling on stress levels in older adults. Uncertainty due to change to motorized bicycle or fear of falling can be perceived as stressors for cyclists. Stress activates different physiological signal cascades and stimulates the hypothalamic-pituitary-adrenal (HPA) axis, which leads to the release of the stress hormone cortisol and further effects such as the development of low-grade inflammation. Both can-in the long term-be associated with negative health outcomes. The aim of the study SiFAr-Stress is to analyze inflammatory processes as well as the activity of stress systems before and after a cycling intervention for older adults.MethodsIn this study, community-dwelling older adults aged 65 years and older will be randomly assigned to either a cycling or a control intervention in a parallel-group design. Objective HPA axis-related measures (saliva cortisol and hair cortisol) will be assessed before, after, and 6-9 months after the cycling and control intervention (T0, T1, and T2). Furthermore, changes in cortisol reactivity in response to the cycling intervention will be investigated at the second and seventh training lessons. Furthermore, secondary outcomes (fear of falling, perceived stress, salivary alpha amylase, and C-reactive protein) will be assessed at T0, T1, and T2.DiscussionThe study will be the first, in which stress- and health-related bio-physiological outcomes will be assessed in the context of a multicomponent exercise intervention, addressing cycling in older adults. It will enable us to better understand the underlying patho-physiological and psychological mechanisms and will help to improve interventions for this target group.Trial registrationClinicalTrials.gov NCT04362514 . Prospectively registered on 27 April 2020.
| S-EPMC8379566 | biostudies-literature
Project description:BackgroundPrecision medicine, optimized interventions, and access to care are catchphrases for the future of behavioral treatments. Progress has been slow due to the dearth of clinical trials that optimize interventions' benefits, individually tailor interventions to meet individual needs and preferences, and lead to rapid implementation after effectiveness is demonstrated. Two innovations have emerged to meet these challenges: fully remote trials and precision clinical trials.ObjectiveThis paper provides a detailed description of Mindful MyWay, a study designed to test online mindfulness training in older adults with depression. Consistent with the concept of fully remote trials using a smartphone app, the study requires no in-person contact and can be conducted with participants anywhere in the United States. Based upon the precision medicine framework, the study assesses participants using high-frequency assessments of symptoms, cognitive performance, and patient preferences to both understand the individualized nature of treatment response and help individually tailor the intervention.MethodsMindful MyWay is an open-label early-phase clinical trial for individuals 65 years and older with current depression. A smartphone app was developed to help coordinate the study, deliver the intervention, and evaluate the acceptability of the intervention, as well as predictors and outcomes of it. The curriculum for the fully remote intervention parallels the mindfulness-based stress reduction curriculum, a protocolized group-based mindfulness training that is typically provided in person. After consent and screening, participants download The Healthy Mind Lab mobile health smartphone app from the Apple App Store, allowing them to complete brief smartphone-based assessments of depressive symptoms and cognitive performance 4 times each day for 4 weeks prior to and after completing the intervention. The intervention consists of an introduction video and 10 weekly mindfulness training sessions, with the expectation to practice mindfulness at home daily. The app collects participant preference data throughout the 10-week intervention period; these high-frequency assessments identify participants' individually dynamic preferences toward the goal of optimizing the intervention in future iterations.ResultsParticipant recruitment and data collection began in March 2019. Final end point assessments will be collected in May 2022. The paper describes lessons learned regarding the critical role of early-phase testing prior to moving to a randomized trial.ConclusionsThe Mindful MyWay study is an exemplar of innovative clinical trial designs that use smartphone technology in behavioral and neuropsychiatric conditions. These include fully remote studies that can recruit throughout the United States, including hard-to-access areas, and collect high-frequency data, which is ideal for idiographic assessment and individualized intervention optimization. Our findings will be used to modify our methods and inform future randomized controlled trials within a precision medicine framework.Trial registrationClinicalTrials.gov NCT03922217; https://clinicaltrials.gov/ct2/show/NCT03922217.International registered report identifier (irrid)DERR1-10.2196/39233.
| S-EPMC9650569 | biostudies-literature