Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer.
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ABSTRACT:
SUBMITTER: Chen HM
PROVIDER: S-EPMC4453645 | biostudies-other | 2015 Feb
REPOSITORIES: biostudies-other
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Project description:IntroductionThe college years are a peak period for the onset of common mental disorders. Poor mental health is associated with low academic attainment, physical, interpersonal and cognitive impairments. Universities can use online approaches to screen students for mental disorders and treat those in need. The present study aims to assess the effectiveness of a guided web-based transdiagnostic individually tailored intervention to treat students with symptoms of depression and/or anxiety.Methodsand analysis : The present study is a randomised controlled trial. Participants are Dutch college students (≥18 years) with mild to moderate depression and/or anxiety symptoms. The intervention is a guided web-based transdiagnostic individually tailored intervention that targets symptoms of depression and/or anxiety. The intervention consists of seven online sessions with a duration ranging from 4 to 7 weeks depending on individual progress. A booster session is administered 4 weeks after the completion of the seventh session. Primary outcome measures are the Patient Health Questionnaire for depression and the Generalised Anxiety Disorder 7-item scale for anxiety. These scales are administered at screening, post-treatment and follow-up assessments (6 and 12 months post-randomisation). : E THICS AND DISSEMINATION: The Medical Ethics Committee of the Vrije Universiteit Medical Centre has approved the protocol (registration number 2016.583, A2017.362andA2018.421). Results of the trial will be published in a peer-reviewed journal.Trial registration numberNTR6797; Pre-results.
| S-EPMC6530301 | biostudies-literature
Project description:AimThe intensity of the most appropriate exercise to use in depressed youth is unclear due to differences in methodology and the lack of evidence documenting the effect of physical activity in children. Therefore, the authors of this study attempted to document the effectiveness of different training intensities to reduce symptoms of depression and anxiety in pre-teens.MethodsThe study included twenty-seven, randomly selected pre-adolescents (aged between 9-11 years of age) all of whom had Primary education. The participants were enrolled and, over a 5-week period, were subject to either intensive or low-to-moderate exercise programs four times a week. Psychological self-reports, as well as physical examinations, were conducted before and after such programs in blinded assessments. Psychological effects were considered the primary outcome, whilst physical condition was secondary.ResultsFour subjects were lost and twenty-three were analyzed. General linear model with 2 criteria revealed significant changes (p = 0.05) in trait anxiety symptoms over time in the low-to-moderate intensity group (LMIG). Within group changes followed a significant decrease in levels of anxiety (38.82 ± 2.20 to 33.36 ± 2.83, p = 0.004) and depression (10.36 ± 2.83 to 6.73 ± 1.88, p = 0.006) related symptoms amongst those in the LMIG.InterpretationThis study indicated that depression and anxiety symptoms were reduced amongst a non-clinical sample of Primary educated pre-adolescents when they were subject to a low-to-moderate exercise program. The program focused on associating movement with pleasure, encouraged positive and non-competitive interactions between participants.Clinical trial registrationwww.ClinicalTrials.gov, identifier NCT02970825, autumn 2016, updated May 7, 2018 (https://clinicaltrials.gov/ct2/show/NCT02970825).
| S-EPMC6694801 | biostudies-literature
Project description:BackgroundBreast cancer patients are recommended to engage in regular exercise. In developing countries, where there is a lack of facilities to offer specialized, supervised exercise for this population, regularly exercising might be a challenge. We aimed to evaluate the effectiveness of a home-based intervention in this population.MethodsBreast cancer survivors were randomly assigned to either the home-based exercise program or the usual care group. Exercise intervention included walking, balance, and stretch exercises, along with weekly follow-up telephone calls. Quality of life (QOL) was evaluated using EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires and the predicted VO2 peak was measured using the Ebbeling submaximal treadmill test.ResultsEighty-nine patients were enrolled in the study. Reported minutes of exercise gradually increased from 40.7 min per week in week 1 to 116.9 min per week in week 12. This intervention improved global QOL (P = 0.001), social functioning (P = 0.04), and the predicted VO2 peak (P = 0.01).ConclusionThis home-based exercise regime effectively increased quality of life and physical activity levels.Trial registryIranian Registry of Clinical Trials identifier: IRCT20140810018746N1, prospectively registered 08/01/2018, https://en.irct.ir/trial/27959 .
| S-EPMC10405487 | biostudies-literature
Project description:Exercise therapy in the intermediate stages of peripheral artery disease (PAD) represents an effective solution to improve mobility and quality of life (QoL). Home-based programs, although less effective than supervised programs, have been found to be successful when conducted at high intensity by walking near maximal pain. In this randomized trial, we aim to compare a low-intensity, pain-free structured home-based exercise (SHB) program to an active control group that will be advised to walk according to guidelines. Sixty PAD patients aged > 60 years with claudication will be randomized with a 1:1 ratio to SHB or Control. Patients in the training group will be prescribed an interval walking program at controlled speed to be performed at home; the speed will be increased weekly. At baseline and after 6 months, the following outcomes will be collected: pain-free walking distance and 6-min walking distance (primary outcome), ankle-brachial index, QoL by the VascuQoL-6 questionnaire, foot temperature by thermal camera, 5-time sit-to-stand test, and long-term clinical outcomes including revascularization rate and mortality. The home-based pain-free exercise program may represent a sustainable and cost effective option for patients and health services. The trial has been approved by the CE-AVEC Ethics Committee (898/20). Registration details: Clinicaltrials.gov NCT04751890 [Registered: 12 February 2021].
| S-EPMC8163172 | biostudies-literature
Project description:BACKGROUND:Depression and anxiety symptoms are common among university students, but many do not receive treatment. This is often because of lack of availability, reluctance to seek help, and not meeting the diagnostic criteria required to access services. Internet-based interventions, including smartphone apps, can overcome these issues. However, a large number of apps are available, each with little evidence of their effectiveness. OBJECTIVE:This study aims to evaluate for the first time the effectiveness of a self-guided mobile app, Feel Stress Free, for the treatment of depression and anxiety symptoms in students. METHODS:A web-based randomized controlled trial compared a cognitive behavioral therapy (CBT)-based mobile app Feel Stress Free with a wait-list control. University students self-identified as experiencing symptoms of anxiety or depression and were randomized to 6 weeks of intervention (n=84) or control (n=84), unblinded. The app is self-guided and incorporates behavioral relaxation activities, mood tracking and thought challenging, and minigames. Participants completed the Hospital Anxiety and Depression Scale online at baseline and every fortnight. RESULTS:At week 6, the primary end point, there was evidence that the Feel Stress Free app reduced depression symptoms (mean difference -1.56; 95% CI -2.67 to -0.44; P=.006) but only very weak evidence that it reduced anxiety symptoms (mean difference -1.36; 95% CI -2.93 to 0.21; P=.09). At week 4, there was evidence to support the effectiveness of the intervention for anxiety symptoms (mean difference -1.94; 95% CI -3.11 to -0.77; P=.001) and, though weaker, depression symptoms (mean difference -1.08; 95% CI -2.12 to -0.04; P=.04). At week 6, 83% (34/41) of participants indicated that they were using the app weekly or more frequently. CONCLUSIONS:The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT. Further research is needed to establish its effectiveness at and beyond 6 weeks. TRIAL REGISTRATION:ClinicalTrials.gov NCT03032952; https://clinicaltrials.gov/ct2/show/NCT03032952.
| S-EPMC7428915 | biostudies-literature
Project description:Clinical practice guidelines state there is insufficient evidence to support advising patients with peripheral artery disease (PAD) to participate in a home-based walking exercise program.To determine whether a home-based walking exercise program that uses a group-mediated cognitive behavioral intervention, incorporating both group support and self-regulatory skills, can improve functional performance compared with a health education control group in patients with PAD with and without intermittent claudication.Randomized controlled clinical trial of 194 patients with PAD, including 72.2% without classic symptoms of intermittent claudication, performed in Chicago, Illinois between July 22, 2008, and December 14, 2012.Participants were randomized to 1 of 2 parallel groups: a home-based group-mediated cognitive behavioral walking intervention or an attention control condition.The primary outcome was 6-month change in 6-minute walk performance. Secondary outcomes included 6-month change in treadmill walking, physical activity, the Walking Impairment Questionnaire (WIQ), and Physical and Mental Health Composite Scores from the 12-item Short-Form Health Survey.Participants randomized to the intervention group significantly increased their 6-minute walk distance ([reported in meters] 357.4 to 399.8 vs 353.3 to 342.2 for those in the control group; mean difference, 53.5 [95% CI, 33.2 to 73.8]; P?<?.001), maximal treadmill walking time (intervention, 7.91 to 9.44 minutes vs control, 7.56 to 8.09; mean difference, 1.01 minutes [95% CI, 0.07 to 1.95]; P?=?.04), accelerometer-measured physical activity over 7 days (intervention, 778.0 to 866.1 vs control, 671.6 to 645.0; mean difference, 114.7 activity units [95% CI, 12.82 to 216.5]; P?=?.03), WIQ distance score (intervention, 35.3 to 47.4 vs control, 33.3 to 34.4; mean difference, 11.1 [95% CI, 3.9 to 18.1]; P?=?.003), and WIQ speed score (intervention, 36.1 to 47.7 vs control, 35.3-36.6; mean difference, 10.4 [95% CI, 3.4 to 17.4]; P?=?.004).A home-based walking exercise program significantly improved walking endurance, physical activity, and patient-perceived walking endurance and speed in PAD participants with and without classic claudication symptoms. These findings have implications for the large number of patients with PAD who are unable or unwilling to participate in supervised exercise programs.clinicaltrials.gov Identifier: NCT00693940.
| S-EPMC6007977 | biostudies-literature
Project description:BackgroundSpecialised palliative care trials often fail to address intervention effects on caregiver anxiety and depression, particularly in bereavement. We evaluate effects of specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression in a randomised controlled trial (RCT).MethodsPatients with incurable cancer and limited antineoplastic treatment options and their caregivers, recruited from a university hospital oncology department, were randomised (1:1) to care as usual or accelerated transition from oncological treatment to home-based specialised palliative care. We assessed caregivers' symptoms of anxiety and depression with the Symptom Checklist-92 up to six months after randomisation and 19 months into bereavement, and estimated intervention effects in mixed effects models.ResultsThe 'Domus' trial enrolled 258 caregivers. The intervention significantly attenuated increases in caregivers' symptoms of anxiety overall (estimated difference, -0.12; 95% confidence interval, -0.22 to -0.01, p = 0.0266), and symptoms of depression at eight weeks (-0.17; -0.33 to -0.02; p = 0.0314), six months (-0.27; -0.49 to -0.05; p = 0.0165), and in bereavement at two weeks (-0.28; -0.52 to -0.03; p = 0.0295) and two months (-0.24; -0.48 to -0.01; p = 0.0448).ConclusionsThis first RCT evaluating specialised palliative care with dyadic psychological support significantly attenuated caregiver anxiety and depression before and during bereavement. (Clinicaltrials.gov: NCT01885637).
| S-EPMC6265292 | biostudies-literature
Project description:BackgroundSymptoms of anxiety, depression and fatigue are common comorbidities among persons with multiple sclerosis (PwMS). A previous pilot study supported Pilates as a feasible exercise modality that may improve these outcomes among PwMS.ObjectiveTo quantify the effects of 8 weeks of home-based Pilates on symptoms of anxiety, depression and fatigue among PwMS.MethodsA total of 80 PwMS (69 female) were randomized to twice-weekly home-based Pilates guided by a DVD) or wait-list control. Validated questionnaires assessed anxiety, depressive and fatigue symptoms at baseline, weeks 2, 4, 6 and 8. Using intention to treat, repeated measures analysis of covariance (RM-ANCOVA) adjusted for baseline physical activity examined between-group differences across time. Hedges' d quantified the magnitude of differences in outcome change. Sensitivity analyses examined female-only samples.ResultsGroup × time interactions were statistically significant for all outcomes (all p ⩽ 0.005). Pilates significantly reduced (all p ⩽ 0.03) depressive symptoms (Quick Inventory of Depressive Symptomatology, d = 0.70; Hospital Anxiety and Depression Scale-Depression, d = 0.74), anxiety (State-Trait Anxiety Inventory, d = 0.30; Hospital Anxiety and Depression Scale-Anxiety, d = 0.49), cognitive (d = 0.44), physical (d = 0.78), psychosocial (d = 0.56) and total fatigue (d = 0.76). Female-only results were materially the same.ConclusionHome-based Pilates significantly improved anxiety, depressive and fatigue symptoms among PwMS with minimal-to-mild mobility disability, including moderate-to-large, clinically meaningful improvements in depressive and fatigue symptoms.Trial Registration: ClinicalTrials.gov (NCT04120207).
| S-EPMC8597189 | biostudies-literature
Project description:INTRODUCTION:Children with cerebral palsy (CP) and other neurodevelopmental disabilities often receive a home programme of exercises to assist in reaching their therapy goals. Adherence to exercise programmes is necessary to attain the level of practice required to achieve goals; however, adherence can be difficult to accomplish. In this paper, we describe the protocol for a randomised controlled trial to evaluate the effectiveness of delivering a home exercise programme to school-age children with disabilities using Physitrack, an online exercise prescription tool with a website or app interface. METHODS AND ANALYSIS:Participants aged 6-17 years, with CP or other neurodevelopmental disabilities, receiving community physiotherapy services in Western Australia, will be recruited. Participants will be stratified by age and functional mobility and randomised to either the intervention group, who will complete an 8-week home exercise programme using Physitrack, or the control group, who will complete an 8-week exercise programme without Physitrack. Researcher blinding to group allocation, and participant blinding to outcome, will be maintained. The primary outcome measures are adherence to the home exercise programme with weekly collection of home exercise logs; achievement of individualised goals by phone interview before and after intervention; and correctness of exercise performance by collection and analysis of videos of participants performing home exercises. Secondary outcome measures include enjoyment of physical activity, confidence to complete exercise programme, preferred method of delivery of programme and usability of Physitrack. A sample size of 58 participants will be necessary to see an effect on home programme adherence. Data will be analysed using the intention-to-treat principle. ETHICS AND DISSEMINATION:Ethical approval was obtained from Curtin University Human Research Ethics Committee in July 2016 (10391). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER:ACTRN12616000743460; Pre-results.
| S-EPMC5786075 | biostudies-literature
Project description:BackgroundAnxiety and depression are common among patients attending cardiac rehabilitation services. Currently available pharmacological and psychological interventions have limited effectiveness in this population. There are presently no psychological interventions for anxiety and depression integrated into cardiac rehabilitation services despite emphasis in key UK National Health Service policy. A new treatment, metacognitive therapy, is highly effective at reducing anxiety and depression in mental health settings. The principal aims of the current study are (1) to evaluate the acceptability of delivering metacognitive therapy in a home-based self-help format (Home-MCT) to cardiac rehabilitation patients experiencing anxiety and depressive symptoms and conduct a feasibility trial of Home-MCT plus usual cardiac rehabilitation compared to usual cardiac rehabilitation; and (2) to inform the design and sample size for a full-scale trial.MethodsThe PATHWAY Home-MCT trial is a single-blind feasibility randomised controlled trial comparing usual cardiac rehabilitation (control) versus usual cardiac rehabilitation plus home-based self-help metacognitive therapy (intervention). Economic and qualitative evaluations will be embedded within the trial. Participants will be assessed at baseline and followed-up at 4 and 12 months. Patients who have been referred to cardiac rehabilitation programmes and have a score of ≥ 8 on the anxiety and/or depression subscales of the Hospital Anxiety and Depression Scale will be invited to take part in the study and written informed consent will be obtained. Participants will be recruited from the National Health Service in the UK. A minimum of 108 participants will be randomised to the intervention and control arms in a 1:1 ratio.DiscussionThe Home-MCT feasibility randomised controlled trial will provide evidence on the acceptability of delivering metacognitive therapy in a home-based self-help format for cardiac rehabilitation patients experiencing symptoms of anxiety and/or depression and on the feasibility and design of a full-scale trial. In addition, it will provide provisional point estimates, with appropriately wide measures of uncertainty, relating to the effectiveness and cost-effectiveness of the intervention.Trial registrationClinicalTrials.gov, NCT03129282 , Submitted to Registry: 11 April 2017.
| S-EPMC6097432 | biostudies-literature