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Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors.

ABSTRACT: To improve adherence to physical activity (PA), behavioural support in the form of behavioural change counselling may be necessary. However, limited evidence of the effectiveness of home-based PA combined with counselling in breast cancer patients exists. The aim of this current randomised controlled trial with a parallel group design was to evaluate the effectiveness of a home-based PA intervention on PA levels, anthropometric measures, health-related quality of life (HRQoL), and blood biomarkers in breast cancer survivors.Eighty post-adjuvant therapy invasive breast cancer patients (age = 53.6 ± 9.4 years; height = 161.2 ± 6.8 cm; mass = 68.7 ± 10.5 kg) were randomly allocated to a 6-month home-based PA intervention or usual care. The intervention group received face-to-face and telephone PA counselling aimed at encouraging the achievement of current recommended PA guidelines. All patients were evaluated for our primary outcome, PA (International PA Questionnaire) and secondary outcomes, mass, BMI, body fat %, HRQoL (Functional assessment of Cancer Therapy-Breast), insulin resistance, triglycerides (TG) and total (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) cholesterol were assessed at baseline and at 6-months.On the basis of linear mixed-model analyses adjusted for baseline values performed on 40 patients in each group, total, leisure and vigorous PA significantly increased from baseline to post-intervention in the intervention compared to usual care (between-group differences, 578.5 MET-min?wk(-1), p =?.024, 382.2 MET-min?wk(-1), p =?.010, and 264.1 MET-min?wk(-1), p =?.007, respectively). Both body mass and BMI decreased significantly in the intervention compared to usual care (between-group differences, -1.6 kg, p =?.040, and -.6 kg/m(2), p =?.020, respectively). Of the HRQoL variables, FACT-Breast, Trial Outcome Index, functional wellbeing, and breast cancer subscale improved significantly in the PA group compared to the usual care group (between-group differences, 5.1, p =?.024; 5.6, p =?.001; 1.9 p =?.025; and 2.8, p =?.007, respectively). Finally, TC and LDL-C was significantly reduced in the PA group compared to the usual care group (between-group differences, -.38 mmol?L(-1), p =?.001; and -.3 mmol?L(-1), p =?.023, respectively).We found that home-based PA resulted in significant albeit small to moderate improvements in self-reported PA, mass, BMI, breast cancer specific HRQoL, and TC and LDL-C compared with usual care. CLINICALTRIALS.NCT02408107 (March 25, 2015).

SUBMITTER: Lahart IM

PROVIDER: S-EPMC4797234 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors.

Lahart Ian M IM Metsios George S GS Nevill Alan M AM Kitas George D GD Carmichael Amtul R AR

BMC cancer 20160317

<h4>Background</h4>To improve adherence to physical activity (PA), behavioural support in the form of behavioural change counselling may be necessary. However, limited evidence of the effectiveness of home-based PA combined with counselling in breast cancer patients exists. The aim of this current randomised controlled trial with a parallel group design was to evaluate the effectiveness of a home-based PA intervention on PA levels, anthropometric measures, health-related quality of life (HRQoL), ...[more]

PMID: 26988367

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Project description:BackgroundOlder cancer survivors are at risk of the development or worsening of both age- and treatment-related morbidity. Sedentary behavior increases the risk of or exacerbates these chronic conditions. Light-intensity physical activity (LPA) is more common in older adults and is associated with better health and well-being. Thus, replacing sedentary time with LPA may provide a more successful strategy to reduce sedentary time and increase physical activity.ObjectiveThis study primarily aims to evaluate the feasibility, acceptability, and preliminary efficacy of a home-based mobile health (mHealth) intervention to interrupt and replace sedentary time with LPA (standing and stepping). The secondary objective of this study is to examine changes in objective measures of physical activity, physical performance, and self-reported quality of life.MethodsOverall, 54 cancer survivors (aged 60-84 years) were randomized in a 1:1:1 allocation to the tech support intervention group, tech support plus health coaching intervention group, or waitlist control group. Intervention participants received a Jawbone UP2 activity monitor for use with their smartphone app for 13 weeks. Tech support and health coaching were provided via 5 telephone calls during the 13-week intervention. Sedentary behavior and physical activity were objectively measured using an activPAL monitor for 7 days before and after the intervention.ResultsParticipants included survivors of breast cancer (21/54, 39%), prostate cancer (16/54, 30%), and a variety of other cancer types; a mean of 4.4 years (SD 1.6) had passed since their cancer diagnosis. Participants, on average, were 70 years old (SD 4.8), 55% (30/54) female, 24% (13/54) Hispanic, and 81% (44/54) overweight or obese. Malfunction of the Jawbone trackers occurred in one-third of the intervention group, resulting in enrollment stopping at 54 rather than the initial goal of 60 participants. Despite these technical issues, the retention in the intervention was high (47/54, 87%). Adherence was high for wearing the tracker (29/29, 100%) and checking the app daily (28/29, 96%) but low for specific aspects related to the sedentary features of the tracker and app (21%-25%). The acceptability of the intervention was moderately high (81%). There were no significant between-group differences in total sedentary time, number of breaks, or number of prolonged sedentary bouts. There were no significant between-group differences in physical activity. The only significant within-group change occurred within the health coaching group, which increased by 1675 daily steps (95% CI 444-2906; P=.009). This increase was caused by moderate-intensity stepping rather than light-intensity stepping (+15.2 minutes per day; 95% CI 4.1-26.2; P=.008).ConclusionsA home-based mHealth program to disrupt and replace sedentary time with stepping was feasible among and acceptable to older cancer survivors. Future studies are needed to evaluate the optimal approach for replacing sedentary behavior with standing and/or physical activity in this population.Trial registrationClinicalTrials.gov NCT03632694; https://clinicaltrials.gov/ct2/show/NCT03632694.

Project description:BackgroundEmerging research suggests that increasing physical activity can help improve cognition among breast cancer survivors. However, little is known about the mechanism through which physical activity impacts cancer survivors' cognition.ObjectiveThe objective of this secondary analysis examined physical and psychological function potentially linking physical activity with changes in cognition among breast cancer survivors in a randomized controlled trial where the exercise arm had greater improvements in cognition than the control arm.MethodsA total of 87 sedentary breast cancer survivors were randomized to a 12-week physical activity intervention (n=43) or control condition (n=44). Objectively measured processing speed (National Institutes of Health Toolbox Oral Symbol Digit), self-reported cognition (patient-reported outcomes measurement information system [PROMIS] cognitive abilities), PROMIS measures of physical and psychological function (depression, anxiety, fatigue, and physical functioning), and plasma biomarkers (brain-derived neurotrophic factor, homeostatic model assessment 2 of insulin resistance, and C-reactive protein [CRP]) were collected at baseline and 12 weeks. Linear mixed-effects models tested intervention effects on changes in physical and psychological function variables and biomarkers. Bootstrapping was used to assess mediation. Exploratory analyses examined self-reported cognitive abilities and processing speed as mediators of the intervention effect on physical functioning.ResultsParticipants in the exercise arm had significantly greater improvements in physical functioning (beta=1.23; 95% CI 2.42 to 0.03; P=.049) and reductions in anxiety (beta=-1.50; 95% CI -0.07 to -2.94; P=.04) than those in the control arm. Anxiety significantly mediated the intervention effect on cognitive abilities (bootstrap 95% CI -1.96 to -0.06), whereas physical functioning did not (bootstrap 95% CI -1.12 to 0.10). Neither anxiety (bootstrap 95% CI -1.18 to 0.74) nor physical functioning (bootstrap 95% CI -2.34 to 0.15) mediated the intervention effect on processing speed. Of the biomarkers, only CRP had greater changes in the exercise arm than the control arm (beta=.253; 95% CI -0.04 to 0.57; P=.09), but CRP was not associated with cognition; therefore, none of the biomarker measures mediated the intervention effect on cognition. Neither cognitive abilities (bootstrap 95% CI -0.06 to 0.68) nor processing speed (bootstrap 95% CI -0.15 to 0.63) mediated the intervention effect on physical function.ConclusionsPhysical activity interventions may improve self-reported cognition by decreasing anxiety. If supported by larger studies, reducing anxiety may be an important target for improving self-reported cognition among cancer survivors.Trial registrationClinicalTrials.gov NCT02332876; https://clinicaltrials.gov/ct2/show/NCT02332876.

Project description:BACKGROUND:The current study assessed the feasibility of a mentored home-based vegetable gardening intervention and examined changes in health-related outcomes among breast cancer survivors (BCS). METHODS:BCS were randomized to either a year-long vegetable gardening intervention to begin immediately or a wait-list control. Master Gardeners mentored participants in planning, planting, and maintaining 3 seasonal gardens over the course of 1 year. Participant accrual, retention, and satisfaction rates of ?80% served as feasibility (primary outcome) benchmarks. Secondary outcomes (ie, vegetable consumption, physical activity, performance and function, anthropometrics, biomarkers, and health-related quality of life) were collected at baseline and post-intervention (1-year follow-up) using subjective and objective measures. RESULTS:The trial surpassed all feasibility benchmarks at 82% of targeted accrual, 95% retention, and 100% satisfaction (ie, experience ratings of "good to excellent" and willingness to "do it again"). Compared with the controls, intervention participants reported significantly greater improvements in moderate physical activity (+14 vs -17 minutes/week) and demonstrated improvements in the 2-Minute Step Test (+22 vs?+?10 steps), and Arm Curl (+2.7 vs?+?0.1 repetitions) (P values?<?.05). A trend toward improved vegetable consumption was observed (+0.9 vs?+?0.2 servings/day; P?=?.06). Approximately 86% of participants were continuing to garden at the 2-year follow-up. CONCLUSIONS:The results of the current study suggest that a mentored, home-based vegetable gardening intervention is feasible and offers an integrative and durable approach with which to improve health behaviors and outcomes among BCS. Harvest for Health led to the establishment of a group of trained Master Gardeners and gave rise to local and global community-based programs. Larger studies are needed to confirm the results presented herein and to define applicability across broader populations of survivors.

Project description:BackgroundMany Polio survivors have reduced mobility, pain and fatigue, which make access to conventional forms of aerobic exercise difficult. Inactivity leads to increased risk of health problems, many of which are prevalent among Polio survivors. Aerobic exercise programmes in Polio survivors should utilise stable muscle groups and should be designed to minimise exacerbation of pain and fatigue. A home-based arm ergometry aerobic exercise programme may represent an affordable and accessible exercise modality, incorporating exercise prescription principles in this group.Methods/designThis is a prospective, single blinded, randomised controlled trial. There are two arms; exercise intervention using arm ergometers and control. Polio survivors meeting eligibility criteria will be recruited and randomly allocated to intervention or control groups. Participants allocated to the intervention group will receive a small arm ergometer and a polar heart rate monitor. They will carry out a home-based moderate intensity (50-70% HRMax) aerobic exercise programme for eight weeks, following instruction by the treating physiotherapist. Assessments will occur at baseline and after eight weeks and will include tests of physical fitness, activity, energy cost of walking, fatigue and quality of life. Clinically feasible assessment tools including the Six Minute Arm Test, the Physical Activity Scale for People with Physical Disabilities questionnaire, the Physiological Cost Index, Fatigue Severity Scale and the SF-36v2 will be utilised.DiscussionThe efficacy of a home-based arm ergometry programme in Polio survivors will be examined. No previous trial has examined such a programme using a wide range of outcome measures pertinent to Polio survivors. This study will provide new information on the impact of arm ergometry on physical fitness, activity, body composition, fatigue, pain, muscle strength, and health related quality of life. Also, the study will provide information, which at present is lacking, on safety of aerobic exercise in Polio, as potential negative outcomes of activity including loss of muscle strength, increased pain and fatigue will be closely monitored.

Project description:BackgroundStroke causes lasting brain damage that has numerous impacts on the survivor's physical, psychosocial, and spiritual well-being. Young survivors (<?65?years old) tend to suffer more because of their longer overall survival time. Expressive arts-based intervention is considered a holistic approach for stroke rehabilitation because it allows participants to express their thoughts and emotions through the arts. The group environment also promotes mutual support among participants. The creative art-making process helps expand participants' creativity and imagination as well as promote a sense of aesthetic appreciation. Previous studies have shown the effectiveness of the arts-based intervention in managing stroke and its psychosocial-spiritual comorbidities. Nevertheless, a systematic study has not been conducted, including in young survivors. This trial plans to investigate the effectiveness of an expressive arts-based intervention on bio-psychosocial-spiritual outcomes in young Chinese stroke survivors.Methods/designA single-blind, two-arm cluster randomised control trial with a waitlist control design will be adopted. One hundred and fifty-four stroke survivors, aged 18-64?years with modified Rankin Scale scores of 1-4, will be screened and randomised to either an expressive arts-based intervention group or a treatment-as-usual waitlist control group. The intervention group will receive a 90-min session once a week for a total of 8 weeks. All participants will be assessed three times: at baseline, 8 weeks, and 8 months after the baseline. Study outcomes include measures of depression and anxiety, perceived stress, perceived social support, hope, spiritual well-being, quality of life, salivary cortisol, blood pressure, and heart rate.DiscussionThis study is expected to contribute to the current knowledge on the effectiveness of an arts-based intervention on the holistic wellness of young stroke survivors. The findings will help stroke survivors and healthcare professionals make better choices in selecting practices that will yield maximum benefits, satisfaction, adherence, and sustainability. In addition, the examination of the relationships between bio-psychosocial-spiritual variables will help contribute to the development of holistic care for the survivors.Trial registrationClinicalTrials.gov , NCT03729648 . Registered 31 October 2018 - Retrospectively registered, (329 words).

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Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors.

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Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors.

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