Feasibility and Effectiveness of Implementing a Novel Exercise and Self-Management Programme during Chemotherapy for Women with Breast Cancer: A Pilot Randomized Controlled Trial
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SUBMITTER: Smith-Turchyn J
PROVIDER: S-EPMC8781477 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionImplementing a health system-based hypertension programme may lower blood pressure (BP).MethodsWe performed a randomized, controlled pilot study to assess feasibility, acceptability, and safety of a home-based virtual hypertension programme integrating evidence-based strategies to overcome current barriers to BP control. Trained clinical pharmacists staffed the virtual collaborative care clinic (vCCC) to remotely manage hypertension using a BP dashboard and phone "visits" to monitor BP, adherence, side effects of medications, and prescribe anti-hypertensives. Patients with uncontrolled hypertension were identified via electronic health records. Enrolled patients were randomized to either vCCC or usual care for 3 months. We assessed patients' home BP monitoring behaviour, and patients', physicians', and pharmacists' perspectives on feasibility and acceptability of individual programme components.ResultsThirty-one patients (vCCC = 17, usual care = 14) from six physician clinics completed the pilot study. After 3 months, average BP decreased in the vCCC arm (P = 0.01), but not in the control arm (P = 0.45). The vCCC participants measured BP more (9.9 vs. 1.2 per week, P < 0.001). There were no intervention-related adverse events. Participating physicians (n = 6), pharmacists (n = 5), and patients (n = 31) rated all programme components with average scores of >4.0, a pre-specified benchmark. Nine adaptations in vCCC design and delivery were made based on potential barriers to implementing the programme and suggestions.ConclusionA home-based virtual hypertension programme using team-based care, technology, and a logical integration of evidence-based strategies is safe, acceptable, and feasible to intended users. These pilot data support studies to assess the effectiveness of this programme at a larger scale.
| S-EPMC10047620 | biostudies-literature
Project description:BackgroundPlantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP.MethodsThis was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation.ResultsEighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64-100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5-0.6, 0.4 and < 0.3, respectively.ConclusionsWe demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP.Trial registration numberISRCTN 12160508 . Prospectively registered 5th July 2016.
| S-EPMC8015033 | biostudies-literature
Project description:Introduction: As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Research suggests that exercise can mitigate several negative health consequences in cancer survivors and improve physical function and quality of life. Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. However, studies evaluating exercise programmes within the Irish population are lacking. Purpose: To evaluate the introduction, implementation and acceptability of a multi-modal exercise rehabilitation programme for deconditioned cancer survivors in a real-world, standard practice setting. Methods and analysis: In this single-arm prospective feasibility study, cancer survivors (n=40) will undergo a 10-week multi-modal exercise programme. The study population will comprise of cancer survivors attending outpatient services in an Irish national cancer centre. Participants will be aged 18 or older and have completed treatment with curative intent. Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes will examine physical function and quality of life measures. In addition, the acceptability of the programme will be assessed through patient feedback. Ethics and dissemination: Ethical approval through the St. James's Hospital and Tallaght University Hospital Research and Ethics Committee is currently pending. The study results will be used to optimise the intervention content and may serve as the foundation for a larger definitive trial. Results will be disseminated through peer-review journals, congresses and relevant clinical groups. Trial registration: ClinicalTrials.gov NCT04026659 (19/07/19).
| S-EPMC8030104 | biostudies-literature
Project description:BackgroundLevels of obesity remain high in the UK. The Football Fans in Training (FFIT) randomised controlled trial (RCT) demonstrated that a 12-week, gender-sensitised weight management, physical activity and healthy eating group programme delivered through professional football clubs helped men aged 35-65 years with BMI at least 28 kg/m2 lose a clinically-significant amount of weight. We aimed to test the feasibility of a minimally-adapted FFIT programme for delivery to women by assessing recruitment and completion rates; determining if the programme content and delivery required further refinement; and evaluating the potential of FFIT for Women to deliver improvements in weight and other clinical, behavioural and psychological outcomes.MethodsA feasibility study of the FFIT for Women programme including before-and-after measurements of clinical (weight, waist, body mass index [BMI], blood pressure) behavioural (self-reported physical activity, food and alcohol intake) and psychological (self-esteem, positive and negative affect, physical and mental HRQoL) outcomes at five professional football clubs. Post-programme focus groups assessed acceptability of the programme format, content and style of delivery for women.ResultsRecruitment across the five clubs resulted in 123 women aged 35-65 years with BMI at least 28 kg/m2 taking part in the study. The mean weight (95.3 kg) and BMI (36.6 kg/m2) of the cohort were both suggestive of high risk of future disease. Of 123 women who started the programme, 94 (76%) completed it; 72 (58.5%) returned for 12-week follow-up measurements. Participants compared FFIT for Women favourably to commercial weight loss programmes and emphasised the importance of the programme's physical activity content. They also spoke positively about group dynamics, suggested that the approach to food was less restrictive than in other weight loss approaches, and broadly enjoyed the football setting. Mean weight loss was 2.87 kg (95% CI 2.09, 3.65, p ≤ 0.001). Mean waist reduction was 3.84 cm (2.92, 4.77, p ≤ 0.001).ConclusionIn this evaluation, FFIT for Women was feasible, acceptable and demonstrated potential as a weight loss programme. Our findings suggest the programme has the potential to produce outcomes that are on a par with existing commercial and state-funded offerings.
| S-EPMC6276211 | biostudies-literature
Project description:PurposeSarcopenia is a poor prognostic factor in cancer patients, and exercise is one of the treatments to improve sarcopenia. However, there is currently insufficient evidence on whether exercise can improve sarcopenia in patients with advanced cancers. This study examined the feasibility of exercise in advanced gastrointestinal (GI) cancer patients treated with palliative chemotherapy.MethodsBetween 2020 and 2021, 30 patients were enrolled in a resistance and aerobic exercise program for six weeks. The exercise intervention program (EIP) consisted of low, moderate, and high intensity levels. Patients were asked to select the intensity level according to their ability. The primary endpoint was the feasibility of the EIP measured by compliance during the six weeks. A compliance of over 50% was considered acceptable. The secondary endpoints were changes in weight and muscle mass, safety, quality of life (QoL) and overall survival (OS).ResultsThe median age of the study's participants was 60 (30-77). The total compliance to the EIP was 63.3% (19/30 patients). Sixteen (53.3%) patients had a compliance of over 80%. The attrition rate was 30.0% (9/30). The mean exercise time was 41.4 min, and the aerobic exercise was 92.3% and the resistant exercise was 73.7%, and both exercise was 66.5%. Most patients performed the moderate intensity level exercises at home or near their home. The mean skeletal muscle index (SMI) was 43.5 cm2/m2 pre-chemotherapy and 42.2 cm2/m2 after six weeks of chemotherapy, with a decrease of -1.2 ± 2.8 cm2/m2 (-3.0%) (p = 0.030). In the poor compliance group, the mean SMI decrease was -2.8 ± 3.0 cm2/m2 which was significantly different (p = 0.033); however, in the good compliance group, the mean SMI decrease was -0.5 ± 2.5 cm2/m2 which was maintained over the six weeks (p = 0.337). The good compliance group had a significantly longer median OS compared with the poor compliance group (25.3 months vs. 7.9 months, HR = 0.306, 95% CI = 0.120-0.784, p = 0.014). The QoL showed a better score for insomnia (p = 0.042). There were no serious adverse events.ConclusionsThe EIP during palliative chemotherapy in advanced GI cancer patients showed good compliance. In the good compliance group, muscle mass and physical functions were maintained for six weeks. The EIP was safe, and the QoL was maintained. Based on this study, further research in exercise intervention in advanced cancer patients is needed.Clinical trial registrationThe clinical trial registration number is KCT 0005615 (CRIS, https://cris.nih.go.kr/cris/en/ ); registration date, 23rd Nov 2020.
| S-EPMC10480261 | biostudies-literature
Project description:A quasi-experimental pilot study was performed to determine the feasibility and safety of an Adapted Physical Activity (APA) protocol and its effect on health-related quality of life (HRQOL), fear of falling, pain, and physical performance in women with osteoporosis-related vertebral fractures. Forty-four post-menopausal women (mean age: 67.6 ± 4.6) with osteoporotic vertebral fractures were assigned to an exercise group (APA group = 26) who attended a six-month exercise protocol that included postural and muscular reinforcement exercises, and a control group (CG = 18) who was asked to maintain their current lifestyle. At baseline and six months after baseline, HRQOL was measured as primary outcome by the Assessment of Health Related Quality of Life in Osteoporosis (ECOS-16) questionnaire. Secondary outcomes were fear of falling (Fall Efficacy Scale International, FES-I), lumbar back pain (Visual Analogue Scale-VAS), functional exercise capacity (Six Minutes Walking Test-6MWT, Borg scale), balance and gait (Tinetti Scale), and flexibility of the column (Chair Sit-and-Reach). The effects of the intervention were analyzed by comparison within groups and between groups. Effect sizes (ES) were calculated using Cohen's d. All the outcomes significantly improved in the APA group, while they remained unchanged in the CG. After adjustment for unbalanced variables, the comparison between groups showed significant effects of the intervention for ECOS-16-score, functional exercise capacity, balance, and gait. The exercise program had big effect sizes on HRQOL (ES = 1.204), fear of falling (ES = 1.007), balance (ES = 0.871), and functional exercise capacity (ES = 1.390). Good adherence (75.8%) and no injuries were observed. Due to its feasibility, safety, and effectiveness, the proposed exercise protocol can be adopted in APA programs addressed to patients with osteoporosis-related vertebral fractures.
| S-EPMC6679098 | biostudies-literature
Project description:The objective of the study was to examine the feasibility and benefits of a group resistance training exercise programme for improving muscle function in institutionalised older adults. A feasibility and acceptability study was designed for a residential aged care (RAC) facility, based on the Gold Coast, Australia. Thirty-seven adults, mean age 86.8 ± 6.1 years (30 females) living in a RAC facility. Participants were allocated into an exercise (n = 20) or control (n = 17) group. The exercise group, the Group Aged Care Exercise (GrACE) programme, performed 12 weeks of twice weekly resistance exercises. Feasibility was measured via recruitment rate, measurement (physiological and surveys) completion rate, loss-to-follow-up, exercise session adherence, adverse events, and ratings of burden and acceptability. Muscle function was assessed using gait speed, sit-to-stand and handgrip strength assessments. All intervention participants completed pre- and post-assessments, and the exercise intervention, with 85% (n = 17) of the group attending ≥ 18 of the 24 sessions and 15% (n = 3) attending all sessions. Acceptability was 100% with exercise participants, and staff who had been involved with the programme strongly agreed that the participants "Benefited from the programme." There were no adverse events reported by any participants during the exercise sessions. When compared to the control group, the exercise group experienced significant improvements in gait speed (F(4.078) = 8.265, p = 0.007), sit to stand performance (F(3.24) = 11.033, p = 0.002) and handgrip strength (F(3.697) = 26.359, p < 0.001). Resistance training via the GrACE programme is feasible, safe and significantly improves gait speed, sit-to-stand performance and handgrip strength in RAC adults.
| S-EPMC4878364 | biostudies-literature
Project description:BackgroundChronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed.ObjectiveThis feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain.MethodsThe EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire.ResultsParticipants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, "totally agree" or "agree"; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).Conclusions Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress.Trial registrationClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.
| S-EPMC7647816 | biostudies-literature
Project description:BackgroundIndividuals with disabilities and type 2 diabetes require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching has been shown to be an effective approach for improving behavioral changes in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of and access to health services.ObjectiveThis protocol outlines the study design for implementing the Artificial Intelligence for Diabetes Management (AI4DM) intervention. The protocol will assess the feasibility, acceptability, and preliminary efficacy of the AI4DM telehealth platform for people with disabilities.MethodsThe AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes educational content, and technology access, to 90 individuals with diabetes and physical disabilities. The hypothesis is that this pilot project is feasible and acceptable for adults with permanently impaired mobility and type 2 diabetes. We also hypothesize that adults in the AI4DM intervention groups will have significantly better glycemic control (glycated hemoglobin) and psychosocial and psychological measures than the attention control group at the 3-, 6-, and 12-month follow-ups.ResultsThe AI4DM study was approved by the university's institutional review board, and recruitment and enrollment will begin in October 2021.ConclusionsThe AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for people with disabilities. The AI4DM intervention has the potential to become a scalable and novel method for successfully managing type 2 diabetes in people with disabilities.Trial registrationClinicalTrials.gov NCT04927377; https://clinicaltrials.gov/ct2/show/NCT04927377.International registered report identifier (irrid)PRR1-10.2196/31689.
| S-EPMC8463947 | biostudies-literature
Project description:BackgroundResearch evidence outlines the benefits of intradialytic exercise (IDE), yet implementation into practice has been slow, ostensibly due to a lack of patient and staff engagement. The aim of this quality improvement project was to improve patient outcomes via the introduction of an IDE programme, evaluate patient uptake and sustainability and enhance the engagement of routine haemodialysis (HD) staff with the delivery of the IDE programme.MethodsWe developed and refined an IDE programme, including interventions designed to increase patient and staff engagement that were based on the Theoretical Domains Framework (TDF), using a series of 'Plan, Do, Study, Act' (PDSA) cycles. The programme was introduced at two UK National Health Service HD units. Process measures included patient uptake, withdrawals, adherence and HD staff involvement. Outcome measures were patient-reported functional capacity, anxiety, depression and symptomology. All measures were collected over 12 months.ResultsA total of 95 patients were enrolled in the IDE programme; 64 (75%) were still participating at 3 months, decreasing to 41 (48%) at 12 months. Adherence was high (78%) at 3 months, decreasing to 63% by 12 months. The provision of IDE by HD staff accounted for a mean of 2 (5%) sessions per 3-month time point. Patients displayed significant improvements in functional ability (P = 0.01) and a reduction in depression (P = 0.02) over 12 months, but the effects seen were limited to those who completed the programme.ConclusionsA theory-based IDE programme is feasible and leads to improvement in functional capacity and depression. Sustaining IDE over time is complicated by high levels of patient withdrawal from the programme. Significant change at an organizational level is required to enhance sustainability by increasing HD staff engagement or access to professional exercise support.
| S-EPMC6275440 | biostudies-literature