Protocol of a longitudinal cohort study on physical activity behaviour in physically disabled patients participating in a rehabilitation counselling programme: ReSpAct.
ABSTRACT: INTRODUCTION:Stimulating physical activity behaviour in persons with a physical disability is important, especially after discharge from rehabilitation. A tailored counselling programme covering both the period of the rehabilitation treatment and the first months at home seems on the average effective. However, a considerable variation in response is observed in the sense that some patients show a relevant beneficial response while others show no or only a small response on physical activity behaviour. The Rehabilitation, Sports and Active lifestyle (ReSpAct) study aims to estimate the associations of patient and programme characteristics with patients' physical activity behaviour after their participation in a tailored counselling programme. METHODS AND ANALYSIS:A questionnaire-based nationwide longitudinal prospective cohort study is conducted. Participants are recruited from 18 rehabilitation centres and hospitals in The Netherlands. 2000 participants with a physical disability or chronic disease will be followed during and after their participation in a tailored counselling programme. Programme outcomes on physical activity behaviour and patient as well as programme characteristics that may be associated with differences in physical activity behaviour after programme completion are being assessed. Data collection takes place at baseline and 14, 33 and 52?weeks after discharge from rehabilitation. ETHICS AND DISSEMINATION:The study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Groningen and at individual participating institutions. All participants give written informed consent. The study results will provide new insights into factors that may help explain the differences in physical activity behaviour of patients with a physical disability after they have participated in the same physical activity and sports stimulation programme. Thereby, it will support healthcare professionals to tailor their guidance and care to individual patients in order to stimulate physical activity after discharge in a more efficient and effective way. TRIAL REGISTRATION NUMBER:NTR3961.
Project description:BACKGROUND:Major depressive disorder (MDD) is a widespread and burdensome psychiatric issue. Physical activity counselling may increase lifestyle physical activity and cardiorespiratory fitness in this specific and particularly vulnerable population, which often suffers from both mental and physical health problems. Therefore, this study will examine the impact of a lifestyle physical activity counselling intervention on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers among in-patients diagnosed with MDD compared to controls. Secondary purposes are to examine the acceptability and perceived usefulness of the intervention among these patients, to find out whether the effectiveness of the intervention is moderated by genetic factors, and to compare baseline values with an age- and gender-matched group of healthy controls. METHODS:The study is designed as a multi-centric two-arm randomized clinical trial including an intervention group and a placebo control group, allocation concealment, single-blinding, and intention-to-treat analysis. Participants (N = 334) will be continuously recruited from four clinics specialized in the treatment of MDD. The intervention builds on a standardized, theory-based, low-cost lifestyle physical activity counselling programme, which was specifically designed for an in-patient rehabilitation setting. The placebo control condition consists of general instructions about health-enhancing physical activity. Data assessments will take place 2-3 weeks after admission to in-patient treatment (baseline), and 6 weeks (post) and 12 months (follow-up) after discharge from in-patient treatment. The primary outcome is objectively assessed physical activity at follow-up. DISCUSSION:Because regular physical activity has proven to be an important predictor of long-term response and remission in patients with major depression, we believe that our planned study may lay important groundwork by showing how individually tailored lifestyle physical activity counselling can be integrated into given clinical structures. Improving physical activity may have important implications for tackling metabolic and cardiovascular disease and increasing mood and cognitive functioning in this at-risk population, hence limiting the future burden of multiple chronic conditions. Increased physical activity may also reduce the likelihood of future depressive episodes. By moving towards the primary prevention of chronic physical conditions, much can be done to enhance the quality and quantity of life of people with MDD. TRIAL REGISTRATION:ISRCTN, ISRCTN10469580 . Registered on 3 September 2018.
Project description:Background:Few studies have measured device-based physical activity and sedentary behaviour following a percutaneous coronary intervention (PCI), with no studies comparing these behaviours between countries using the same methods. The aim of the study was to compare device-based physical activity and sedentary behaviour, using a harmonised approach, following a PCI on-entry into centre-based cardiac rehabilitation in two countries. Methods:A cross-sectional study was conducted at two outpatient cardiac rehabilitation centres in Australia and Sweden. Participants were adults following a PCI and commencing cardiac rehabilitation (Australia n =?50, Sweden n =?133). Prior to discharge from hospital, Australian participants received brief physical activity advice (<?5 mins), while Swedish participants received physical activity counselling for 30?min. A triaxial accelerometer (Actigraph GT3X/ActiSleep) was used to objectively assess physical activity (light (LPA), moderate-to-vigorous (MVPA)) and sedentary behaviour. Outcomes included daily minutes of physical activity and sedentary behaviour, and the proportion and distribution of time spent in each behaviour. Results:There was no difference in age, gender or relationship status between countries. Swedish (S) participants commenced cardiac rehabilitation later than Australian (A) participants (days post-PCI A 16 vs S 22, p <?0.001). Proportionally, Swedish participants were significantly more physically active and less sedentary than Australian participants (LPA A 27% vs S 30%, p <?0.05; MVPA A 5% vs S 7%, p <?0.01; sedentary behaviour A 68% vs S 63%, p <?0.001). When adjusting for wear-time, Australian participants were doing less MVPA minutes (A 42 vs S 64, p <?0.001) and more sedentary behaviour minutes (A 573 vs S 571, p <?0.001) per day. Both Swedish and Australian participants spent a large part of the day sedentary, accumulating 9.5?h per day in sedentary behaviour. Conclusion:Swedish PCI participants when commencing cardiac rehabilitation are more physically active than Australian participants. Potential explanatory factors are differences in post-PCI in-hospital physical activity education between countries and pre-existing physical activity levels. Despite this, sedentary behaviour is high in both countries. Internationally, interventions to address sedentary behaviour are indicated post-PCI, in both the acute setting and cardiac rehabilitation, in addition to traditional physical activity and cardiac rehabilitation recommendations. Trial registrations:Australia: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12615000995572. Registered 22 September 2015, Sweden: World Health Organization Trial Registration Data Set: NCT02895451.
Project description:Physical activity promotion in people with Chronic Obstructive Pulmonary Disease (COPD) is focus of research and public health. Patient-centred interventions like counselling are promising approaches to help patients reducing sedentary behaviour. Aim of the present study is to investigate if a physical activity counselling program during pulmonary rehabilitation increases physical activity level in daily life in people with COPD.A two-armed, single blind randomised controlled trial including 56 people with COPD will be conducted in an outpatient pulmonary rehabilitation. Patients will participate in a 12-week-rehabilitation program; individuals randomized to the interventional group will additionally participate in five counselling sessions with a physiotherapist, based on the principles of motivational interviewing. The participants' physical activity level will be measured using an accelerometer (SenseWear Pro®) before, directly and 3 months after pulmonary rehabilitation. Semi-structured interviews will be conducted to learn more about barriers and facilitators regarding daily physical activity.If the strategy successfully improves the physical activity level in people with COPD, counselling might be implemented in pulmonary rehabilitation.Clinical Trials.gov NCT02455206 (05/21/2015), Swiss National Trails Portal SNCTP000001426 (05/21/2015).
Project description:Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay.A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters.The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority.Trial registry http://www.clinicaltrials.gov: NCT01223170.
Project description:An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits, including decreased mortality. Internet- and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation. One component related to the efficacy of these interventions is tailoring of the content to the individual.Our trial assessed the effect of a longitudinally tailored Internet- and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay. We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version.The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone. The participants were randomized in monthly clusters to a tailored or nontailored (control) intervention group. All participants had access to a website with information regarding cardiac rehabilitation, an online discussion forum, and an online activity calendar. Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages. The main outcome was self-reported level of physical activity, which was obtained using an online international physical activity questionnaire at baseline, at discharge, and at 1 month and 3 months after discharge from the cardiac rehabilitation program.Included in the study were 69 participants. One month after discharge, the tailored intervention group (n=10) had a higher median level of overall physical activity (median 2737.5, IQR 4200.2) than the control group (n=14, median 1650.0, IQR 2443.5), but the difference was not significant (Kolmogorov-Smirnov Z=0.823, P=.38, r=.17). At 3 months after discharge, the tailored intervention group (n=7) had a significantly higher median level of overall physical activity (median 5613.0, IQR 2828.0) than the control group (n=12, median 1356.0, IQR 2937.0; Kolmogorov-Smirnov Z=1.397, P=.02, r=.33). The median adherence was 45.0 (95% CI 0.0-169.8) days for the tailored group and 111.0 (95% CI 45.1-176.9) days for the control group; however, the difference was not significant (P=.39). There were no statistically significant differences between the 2 groups in stage of change, self-efficacy, social support, perceived tailoring, anxiety, or depression.Because of the small sample size and the high attrition rate at the follow-up visits, we cannot make conclusions regarding the efficacy of our approach, but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention.ClinicalTrials.gov: NCT01223170; http://clinicaltrials.gov/show/NCT01223170 (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL).
Project description:<h4>Objectives</h4>To support return to work (RTW) among cancer patients, a multidisciplinary rehabilitation programme was developed which combined occupational counselling with a supervised physical exercise programme during chemotherapy. The aim was to investigate RTW rates of cancer patients and to evaluate changes in work-related quality of life and physical outcomes.<h4>Design</h4>Longitudinal prospective intervention study using a one-group design.<h4>Setting</h4>Two hospitals in the Netherlands.<h4>Participants</h4>Of the eligible patients, 56% participated; 93 patients with a primary diagnosis of cancer receiving chemotherapy and on sick leave were included. Patients completed questionnaires on RTW, the importance of work, work ability (WAI), RTW self-efficacy, fatigue (MFI), and quality of life (EORTC QLQ C-30) at baseline and 6, 12 and 18?months follow-up. Before and after the exercise programme 1-repetition maximum (1RM) muscle strength and cardiorespiratory fitness (VO<sub>2</sub> peak) were assessed.<h4>Results</h4>Six months after the start of a multidisciplinary rehabilitation programme that combined occupational counselling with a supervised physical exercise programme, 59% of the cancer patients returned to work, 86% at 12?months and 83% at 18?months. In addition, significant improvements (p<0.05) in the importance of work, work ability, RTW self-efficacy, and quality of life were observed, whereas fatigue levels were significantly reduced. After completing the exercise programme, 1RM muscle strength was significantly increased but there was no improvement in VO<sub>2</sub> peak level.<h4>Conclusions</h4>RTW rates of cancer patients were high after completion of the multidisciplinary rehabilitation programme. A multidisciplinary rehabilitation programme which combines occupational counselling with a supervised physical exercise programme is likely to result in RTW, reduced fatigue and increased importance of work, work ability, and quality of life.
Project description:Osteoarthritis often results in prolonged periods of reduced physical activity and is associated with adverse health outcomes, including increased risk of cardiovascular and metabolic diseases. Exercise interventions for patients on the waiting list for arthroplasty can reduce the risk of long-term adverse outcomes by increasing activity levels. However, uptake and ongoing positive rates of physical activity in this population are low and the impact of pre-operative behaviour counselling on exercise is not known.The exercise and behaviour change counselling (ENHANCE) trial is a two-arm assessor-blind randomised controlled trial to assess the effectiveness of a 12-week exercise intervention designed to improve long-term physical activity and functional abilities for people awaiting arthroplasty. Participants on the waiting list for hip and knee arthroplasty are recruited from one clinical site in Australia. After collection of baseline data, participants are randomised to either an intervention or control group. The control group receive usual care, as recommended by evidence-based guidelines. The intervention group receive an individualised programme of exercises and counselling sessions. The 12-week exercise programme integrates multiple elements, including up to five in-person counselling sessions, supported by written materials. Participants are encouraged to seek social support among their friends and self-monitor their physical activity. The primary outcome is physical activity (daily step count and percentage of day spent in sedentary activities). Secondary outcomes include pain ratings, physical function, psychosocial factors and changes in clinical markers linked with potential common chronic diseases (diabetes and cardiovascular disease). All outcomes are assessed at baseline and 26 weeks later and again at 26 weeks post-surgery.This study seeks to address a significant gap in current osteoarthritis management practice by providing evidence for the effectiveness of an exercise programme combined with behaviour counselling for adults waiting for hip and knee arthroplasty. Theory-driven evidence-based strategies that can improve an individual's exercise self-efficacy and self-management capacity could have a significant impact on the development of secondary chronic disease in this population. Information gained from this study will contribute to the evidence base on the management of adults waiting for hip and knee arthroplasty.Australian New Zealand Clinical Trials Registry, ACTRN12617000357358 . Registered on 8 March 2017.
Project description:This study aims to assess rehabilitation needs and provision of rehabilitation services for individuals with moderate-to-severe disability and investigate factors influencing the probability of receiving rehabilitation within six months after traumatic brain injury (TBI). Overall, the analyses included 1206 individuals enrolled in the CENTER-TBI study with severe-to-moderate disability. Impairments in five outcome domains (daily life activities, physical, cognition, speech/language, and psychological) and the use of respective rehabilitation services (occupational therapy, physiotherapy, cognitive and speech therapies, and psychological counselling) were recorded. Sociodemographic and injury-related factors were used to investigate the probability of receiving rehabilitation. Physiotherapy was the most frequently provided rehabilitation service, followed by speech and occupational therapy. Psychological counselling was the least frequently accessed service. The probability of receiving a rehabilitative intervention increased for individuals with greater brain injury severity (odds ratio (OR) 1.75, CI 95%: 1.27–2.42), physical (OR 1.92, CI 95%: 1.21–3.05) and cognitive problems (OR 4.00, CI 95%: 2.34–6.83) but decreased for individuals reporting psychological problems (OR 0.57, CI 95%: 1.21–3.05). The study results emphasize the need for more extensive prescription of rehabilitation services for individuals with disability. Moreover, targeted rehabilitation programs, which aim to improve outcomes, should specifically involve psychological services to meet the needs of individuals recovering from TBI.
Project description:BACKGROUND:Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing.The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children's obesity. METHODS/DESIGN:The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups. DISCUSSION:This trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01878994.
Project description:INTRODUCTION:Physical exercise after stroke is essential for improving recovery and general health, and reducing future stroke risk. However, people with stroke are not sufficiently active on return to the community after rehabilitation. We developed the Promoting Optimal Physical Exercise for Life (PROPEL) programme, which combines exercise with self-management strategies within rehabilitation to promote ongoing physical activity in the community after rehabilitation. This study aims to evaluate the effect of PROPEL on long-term participation in exercise after discharge from stroke rehabilitation. We hypothesise that individuals who complete PROPEL will be more likely to meet recommended frequency, duration and intensity of exercise compared with individuals who do not complete the programme up to 6?months post discharge from stroke rehabilitation. METHODS AND ANALYSIS:Individuals undergoing outpatient stroke rehabilitation at one of six hospitals will be recruited (target n=192?total). A stepped-wedge design will be employed; that is, the PROPEL intervention (group exercise plus self-management) will be 'rolled out' to each site at a random time within the study period. Prior to roll-out of the PROPEL intervention, sites will complete the control intervention (group aerobic exercise only). Participation in physical activity for 6?months post discharge will be measured via activity and heart rate monitors, and standardised physical activity questionnaire. Adherence to exercise guidelines will be evaluated by (1) number of 'active minutes' per week (from the activity monitor), (2) amount of time per week when heart rate is within a target range (ie, 55%-80% of age-predicted maximum) and (3) amount of time per week completing 'moderate' or 'strenuous' physical activities (from the questionnaire). We will compare the proportion of active and inactive individuals at 6 months post intervention using mixed-model logistic regression, with fixed effects of time and phase and random effect of cluster (site). ETHICS AND DISSEMINATION:To date, research ethics approval has been received from five of the six sites, with conditional approval granted by the sixth site. Results will be disseminated directly to study participants at the end of the trial, and to other stake holders via publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT02951338; Pre-results.