Virtual Group-based Walking Intervention for Persons with Schizophrenia: A Pilot Randomized Controlled Trial.
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SUBMITTER: Browne J
PROVIDER: S-EPMC10135421 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
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Virtual Group-based Walking Intervention for Persons with Schizophrenia: A Pilot Randomized Controlled Trial.
Browne Julia J Battaglini Claudio C Jarskog L Fredrik LF Sheeran Paschal P Abrantes Ana M AM Elliott Tonya T Gonzalez Oscar O Penn David L DL
Mental health and physical activity 20230327
Persons with schizophrenia have reduced cardiorespiratory fitness (CRF), a predictor of all-cause mortality. Exercise is effective for improving CRF; however, motivational challenges affecting those with schizophrenia impact exercise engagement and maintenance. Virtual Physical Activity Can Enhance Life (Virtual PACE-Life), a multicomponent walking intervention guided by self-determination theory (SDT), was developed to target CRF in this population while addressing motivational difficulties. Vi ...[more]
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Project description:BackgroundDespite Internet-based interventions that incorporate pedometers with appropriate goal-setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior, few have incorporated all of these key features or assessed maintenance of behavior change.ObjectiveThe objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts, combined with an interactive support website for step counts, health parameters and motivation over 12 and 24 weeks.MethodsLow active participants (mean [SD] 46.2 [11.2] years) were randomly assigned to the Stepwise (SW) intervention group (n=49) or a comparison (CP) group (n=48). SW received a pedometer, step goal walking program and access to the SW website (containing interactive self-monitoring and goal feedback tools, motivational messages and action and coping planning strategies). CP received a pedometer and locally available physical activity information. Step counts, BMI, resting heart rate, blood pressure and glucose, cholesterol and triglyceride levels, psychological well-being, perceived health, self-efficacy and self-determined motivation were measured at baseline, 12 and 24 weeks.ResultsLinear mixed model analysis found that both groups' step counts increased from baseline to week 12 (β = 11,002, CI 5739-16,266, P<.001) and 24 (β = 6810, CI 1190-12,431; P=.02). Group step counts were significantly different at week 24 with SW taking 8939 (CI 274-17604, P=.04) more steps compared to CP. Compared to baseline, both groups had improved triglyceride levels (0.14 mmol/L, CI -0.25 to -0.02, P=.02) at week 12, decreased diastolic blood pressure (4.22 mmHg, CI -6.73 to -1.72) at weeks 12 and 24 (3.17 mmHg, CI -5.55 to -0.78), improved positive (β = .21, CI 0.03-0.38, P=.02) and negative affect (β = -.15, CI -0.28 to -0.03, P=.02) at week 12, and perceived health at week 12 (β = 6.37, CI 2.10-10.65, P=.004) and 24 (β = 8.52, CI 3.98-13.06, P<.001). Total cholesterol increased at week 12 (0.26 mmol/L, CI 0.099-0.423, P=.006) and week 24 (0.38 mmol/L, CI 0.20-0.56, P<.001). Repeated measures ANOVA found motivation for walking improved from baseline with higher task self-efficacy (P<.001, η(2) = .13) and autonomous motivation (P<.001, η(2)=.14) at weeks 12 and 24 and decreased controlled motivation (P=.004, η(2)=.08) at week 24.ConclusionsBoth groups had similar improvements in step counts and physical and psychological health after 12 weeks but only the SW group successfully maintained the increased step-counts 24 weeks post-intervention. This suggests the step-goal based walking program combined with Internet-based behavior change tools were important for sustained behavior change.
| S-EPMC4746436 | biostudies-literature
Project description:Rationale & objectivePatients receiving dialysis report very low physical activity. We implemented a pilot trial to assess the feasibility of a pedometer-based intervention to gather preliminary evidence about its impact on physical activity, symptoms, and surrogates of cardiovascular risk.Study designPilot randomized controlled trial.Setting & participants60 dialysis patients from San Francisco dialysis clinics.InterventionParticipants were randomly assigned 1:1 to receiving pedometers with weekly step goals or usual care for 3 months.OutcomesThe primary outcome was step counts, measured using pedometers. Secondary outcomes included physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies-Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk. Targeted enrollment was 50% and targeted completion was 85%.Results49% of approached patients were enrolled, and 92% completed the study. After 3 months, patients randomly assigned to the intervention (n=30) increased their average daily steps by 2,256 (95% CI, 978-3,537) more than the 30 controls (P<0.001). Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05). There were no statistically significant differences across intervention groups in symptoms, physical performance, or endothelial function. Participants in the intervention group reverted to baseline steps during the postintervention follow-up.LimitationsThe Northern California study setting may limit generalizability. Walking does not capture the full spectrum of physical activity.ConclusionsA short-term pedometer-based intervention led to increased step counts in dialysis patients, but the increase was not sustained. Pedometer-based interventions are feasible for dialysis patients, but future studies are needed to address whether more prolonged interventions can improve physical function or symptoms.FundingSupported by grants from the American Kidney Fund, National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases, and International Society of Nephrology.Trial registrationRegistered at ClinicalTrials.gov with study identifier NCT02623348.
| S-EPMC7089809 | biostudies-literature
Project description:BackgroundExtensive research suggests that physical activity (PA) is important for brain and cognitive health and may help to delay or prevent Alzheimer's disease and related dementias. Most PA interventions designed to improve brain health in older adults have been conducted in laboratory, gym, or group settings that require extensive resources and travel to the study site or group sessions. Research is needed to develop novel interventions that leverage mobile health (mHealth) technologies to help older adults increase their engagement in PA in free-living environments, reducing participant burden and increasing generalizability of research findings. Moreover, promoting engagement in moderate-to-vigorous PA (MVPA) may be most beneficial to brain health; thus, using mHealth to help older adults increase time spent in MVPA in free-living environments may help to offset the burden of Alzheimer's disease and related dementias and improve quality of life in older age.ObjectiveWe developed a novel PA intervention that leverages mHealth to help older adults achieve more minutes of MVPA independently. This pilot study was a 12-week randomized controlled trial to investigate the feasibility of providing just-in-time (JIT) feedback about PA intensity during free-living exercise sessions to help older adults meet current PA recommendations (150 minutes per week of MVPA).MethodsParticipants were eligible if they were cognitively healthy English speakers aged between 65 and 80 years without major cardiovascular, neurologic, or mental health conditions; could ambulate independently; and undergo magnetic resonance imaging. Enrollment occurred from October 2017 to March 2020. Participants randomized to the PA condition received an individualized exercise prescription and an mHealth device that provided heart rate-based JIT feedback on PA intensity, allowing them to adjust their behavior in real time to maintain MVPA during exercise sessions. Participants assigned to the healthy aging education condition received a reading prescription consisting of healthy aging topics and completed weekly quizzes based on the materials.ResultsIn total, 44 participants were randomized to the intervention. A follow-up manuscript will describe the results of the intervention as well as discuss screening, recruitment, adverse events, and participants' opinions regarding their participation in the intervention.ConclusionsThe long-term goal of this intervention is to better understand how MVPA affects brain and cognitive health in the real world and extend laboratory findings to everyday life. This pilot randomized controlled trial was conducted to determine the feasibility of using JIT heart rate zone feedback to help older adults independently increase time spent in MVPA while collecting data on the plausible mechanisms of change (frontal and medial temporal cerebral blood flow and cardiorespiratory fitness) that may affect cognition (memory and executive function) to help refine a planned stage 2 behavioral trial.Trial registrationClinicalTrials.gov NCT03058146; https://clinicaltrials.gov/ct2/show/NCT03058146.International registered report identifier (irrid)DERR1-10.2196/42980.
| S-EPMC9972211 | biostudies-literature
Project description:OBJECTIVE:To determine preliminary efficacy of a home-based behavior-change intervention designed to promote exercise, walking activity, and disease self-management. DESIGN:A single-blind, randomized controlled pilot trial. SETTING:One Veterans Administration and 2 regional medical centers. PARTICIPANTS:A total of 38 participants randomized to behavior-change intervention (n=19) or attention control (CTL; n=19) group. INTERVENTIONS:Weekly 30-minute telephone sessions for 12 weeks with intervention group sessions focused on health behavior change and CTL group sessions focused on health status monitoring. MAIN OUTCOME MEASURES:Physical function, walking activity (steps/d averaged over 10d), and disability were measured at baseline, 12 weeks (intervention end), and 24 weeks after baseline with the Timed Up and Go (TUG) test as the primary outcome measure. RESULTS:The TUG test was not changed from baseline in either group and was not different between groups after 12 or 24 weeks. Several exploratory outcomes were assessed, including daily step count, which increased 1135 steps per day in the intervention group compared to 144 steps per day in the CTL group after 12 weeks (P=.03). Only the intervention group had within-group increase in steps per day from baseline to 12 (P<.001) and 24 (P=.03) weeks and spent significantly less time in sedentary activity (4.8% decrease) than the CTL group (0.2% decrease) at 24 weeks (P=.04). There were no other between-group differences in physical function or disability change over time. CONCLUSION:The behavior-change intervention demonstrates promise for increasing walking activity for people with dysvascular transtibial amputation (TTA). The efficacy of implementing such intervention in the scope of conventional TTA rehabilitation should be further studied.
| S-EPMC6215727 | biostudies-literature
Project description:BackgroundDespite the functional impact of upper limb dysfunction in multiple sclerosis (MS), effects of intensive exercise programs and specifically robot-supported training have been rarely investigated in persons with advanced MS.AimTo investigate the effects of additional robot-supported upper limb training in persons with MS compared to conventional treatment only.MethodsSeventeen persons with MS (pwMS) (median Expanded Disability Status Scale of 8, range 3.5-8.5) were included in a pilot RCT comparing the effects of additional robot-supported training to conventional treatment only. Additional training consisted of 3 weekly sessions of 30 min interacting with the HapticMaster robot within an individualised virtual learning environment (I-TRAVLE). Clinical measures at body function (Hand grip strength, Motricity Index, Fugl-Meyer) and activity (Action Research Arm test, Motor Activity Log) level were administered before and after an intervention period of 8 weeks. The intervention group were also evaluated on robot-mediated movement tasks in three dimensions, providing active range of motion, movement duration and speed and hand-path ratio as indication of movement efficiency in the spatial domain. Non-parametric statistics were applied.ResultsPwMS commented favourably on the robot-supported virtual learning environment and reported functional training effects in daily life. Movement tasks in three dimensions, measured with the robot, were performed in less time and for the transporting and reaching movement tasks more efficiently. There were however no significant changes for any clinical measure in neither intervention nor control group although observational analyses of the included cases indicated large improvements on the Fugl-Meyer in persons with more marked upper limb dysfunction.ConclusionRobot-supported training lead to more efficient movement execution which was however, on group level, not reflected by significant changes on standard clinical tests. Persons with more marked upper limb dysfunction may benefit most from additional robot-supported training, but larger studies are needed.Trial registrationThis trial is registered within the registry Clinical Trials GOV ( NCT02257606 ).
| S-EPMC4511982 | biostudies-literature
Project description:BACKGROUND:General practitioners play a fundamental role in combatting the current epidemic of physical inactivity, and pedometer-based walking interventions are able to increase physical activity levels of their patients. Supplementing these interventions with email counseling driven by feedback from the pedometer has the potential to further improve their effectiveness but it has to be yet confirmed in clinical trials. Therefore, the aim of our pilot randomized controlled trial is to evaluate the feasibility and potential efficacy of future trials designed to assess the additional benefit of email counseling added to a pedometer-based intervention in a primary care setting. METHODS:Physically inactive patients were opportunistically recruited from four general practices and randomized to a 12-week pedometer-based intervention with or without email counseling. To explore the feasibility of future trials, we assessed the speed and efficiency of recruitment, adherence to wearing the pedometer, and engagement with email counseling. To evaluate the potential efficacy, daily step-count was the primary outcome and blood pressure, waist and hip circumference, and body mass were the secondary outcomes. Additionally, we conducted a qualitative analysis of structured interviews with the participating general practitioners. RESULTS:The opportunistic recruitment has been shown to be feasible and acceptable, but relatively slow and inefficient; moreover, general practitioners selectively recruited overweight and obese patients. Patients manifested high adherence, wearing the pedometer on 83% (± 20) of days. All patients from the counseling group actively participated in email communication and responded to 46% (± 22) of the emails they received. Both groups significantly increased their daily step-count (pedometer-plus-email, + 2119, p = 0.002; pedometer-alone, + 1336, p = 0.03), but the difference between groups was not significant (p = 0.18). When analyzing both groups combined, there was a significant decrease in body mass (- 0.68 kg, p = 0.04), waist circumference (- 1.73 cm, p = 0.03), and systolic blood pressure (- 3.48 mmHg, p = 0.045). CONCLUSIONS:This study demonstrates that adding email counseling to a pedometer-based intervention in a primary care setting is feasible and might have the potential to increase the efficacy of such an intervention in increasing physical activity levels. TRIAL REGISTRATION:The trial was retrospectively registered at ClinicalTrials.gov (ID: NCT03135561 , date: April 26, 2017).
| S-EPMC5956962 | biostudies-literature
Project description:While effective in reducing infections, social distancing during the COVID-19 outbreak may carry ill effects on the mental health of older adults. The present study explored the efficacy of a short-term digital group intervention aimed at providing seniors with the tools and skills necessary for improving their coping ability during these stressful times. A total of 82 community-dwelling adults aged between 65 aged 90 (Mage = 72 years, SD = 5.63) were randomized to either an intervention group (n = 64) or a wait-list control group (n = 18). The intervention comprised online guided sessions in small groups in which behavioral and cognitive techniques were learned and practiced via the ZOOM videoconferencing platform. Loneliness and depression levels were measured pre- and post-participation. The results demonstrated a significant improvement in the intervention group in terms of both loneliness and depressive symptoms, compared with the control group. Results of mixed effect models indicated a medium ameliorative effect on loneliness (d = 0.58), while that for depressive symptoms was only marginally significant and smaller in size (d = 0.43). Our intervention presents a relatively simple and effective technique that can be efficiently utilized to support older adults both during emergencies such as the COVID-19 outbreak, as well as in more routine times for older adults who live alone or reside in remote areas.
| S-EPMC7839498 | biostudies-literature
Project description:BACKGROUND:Balance and trunk control are often impaired in individuals with multiple sclerosis (MS). Interventions addressing these issues are needed. OBJECTIVE:The objective of this study was to compare the immediate and long-term effects of a 6-week individualized, group-based, comprehensive core stability intervention (GroupCoreDIST) with standard care on balance and trunk control in individuals with MS. DESIGN:This study was a prospective, assessor-masked, randomized controlled trial. SETTING:The GroupCoreDIST intervention was conducted by 6 physical therapists in 6 municipalities in Norway. Standard care included the usual care for individuals with MS in the same municipalities. Assessments at all time points took place at a Norwegian hospital. PARTICIPANTS:Eighty people with Expanded Disability Status scores of 1 to 6.5 participated in this trial. INTERVENTION:Randomized, concealed allocation was used to assign the participants to the GroupCoreDIST intervention (n = 40) or to standard care (n = 40). The GroupCoreDIST intervention was conducted with groups of 3 participants (1 group had 4 participants), for 60 minutes 3 times per week. MEASUREMENTS:Assessments were undertaken at baseline and at weeks 7, 18, and 30. Outcomes were measured with the Trunk Impairment Scale-Norwegian Version, Mini Balance Evaluation Systems Test, and Patient Global Impression of Change-Balance. Repeated-measures mixed models were used for statistical analysis. RESULTS:One individual missed all postintervention tests, leaving 79 participants in the intention-to-treat analysis. GroupCoreDIST produced significant between-group effects on the mean difference in the following scores at 7, 18, and 30 weeks: for Trunk Impairment Scale-Norwegian Version, 2.63 points (95% confidence interval [CI] = 1.89-3.38), 1.57 points (95% CI = 0.81-2.33), and 0.95 point (95% CI = 0.19-1.71), respectively; for Mini Balance Evaluation Systems Test, 1.91 points (95% CI = 1.07-2.76), 1.28 points (95% CI = 0.42-2.15), and 0.91 points (95% CI = 0.04-1.77), respectively; and for Patient Global Impression of Change-Balance, 1.21 points (95% CI = 1.66-0.77), 1.02 points (95% CI = 1.48-0.57), and 0.91 points (95% CI = 1.36-0.46), respectively. LIMITATIONS:Groups were not matched for volume of physical therapy. CONCLUSIONS:Six weeks of GroupCoreDIST improved balance and trunk control in the short and long terms compared with standard care in individuals who were ambulant and had MS. The intervention is an effective contribution to physical therapy for this population.
| S-EPMC6665948 | biostudies-literature
Project description:ObjectiveThis study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities.Study designA pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle.ResultsOf 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms.ConclusionDiabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes.Key points· Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..
| S-EPMC7855154 | biostudies-literature
Project description:BackgroundObstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation.ObjectiveThis study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness.MethodsA sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit.ResultsFollow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ21=8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program.ConclusionsResults provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes.Trial registrationISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181.
| S-EPMC7424475 | biostudies-literature