scholarly journals ACCEPTANCE: protocol for a feasibility study of a multicomponent physical activity intervention following treatment for cervical cancer

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e048203
Author(s):  
Nessa Millet ◽  
Hilary J McDermott ◽  
Fehmidah Munir ◽  
Charlotte L Edwardson ◽  
Esther L Moss

IntroductionCervical cancer treatment can have life changing sequelae and be associated with poor short-term and long-term quality of life. Physical activity (PA; that is, bodily movement) is known to improve health outcomes and quality of life for cancer survivors, both physically and psychologically. To date, no interventions to increase PA following cervical cancer have been evaluated. This study aims to (1) determine the feasibility of conducting a PA intervention after cervical cancer and (2) to explore the acceptability of the programme and evaluation measures.Methods and analysisThe design is a pre study and post study design. Thirty participants aged between 18 and 60 years from the Midlands region, UK, who have completed primary treatment for cervical cancer at least 6 months previously and do not meet the national PA guidelines will be recruited. Identification of potential participants will take place through the University Hospitals of Leicester National Health Service (NHS) Trust. Participants will receive an intervention focused on increasing PA through the provision of education, action planning, goal setting, problem solving and self-monitoring of PA behaviour, particularly steps per day. Device assessed PA and questionnaires will be completed at baseline, week 6, week 12 and week 24. Feasibility will be assessed in terms of recruitment, retention, attrition, completion of measures and intervention compliance, for which specific feasibility criteria have been established. The process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures.Ethics and disseminationEthical approval has been granted by the West of Scotland Research Ethics Committee 1 for this study. Results will inform intervention refinement for the design of a definitive pilot trial. These results will be disseminated via peer-reviewed publications and international conferences while input from a patient and public involvement (PPI) group will inform effective ways to circulate results among the wider community.Trial registration numberISRCTN16349793, Registered 30 September 2020.

2021 ◽  
Vol 8 ◽  
pp. 205435812098705
Author(s):  
Kathryn Wytsma-Fisher ◽  
Stefan Mustata ◽  
Theresa Cowan ◽  
Manuel Ester ◽  
S. Nicole Culos-Reed

Background: Low physical activity levels and poor physical functioning are strongly associated with poor clinical outcomes and mortality in adult kidney failure patients, regardless of treatment modality. Compared with the general population, individuals with chronic kidney disease are physically inactive, have reduced physical abilities and difficulties performing routine daily tasks, lower health-related quality of life, and higher cardiovascular morbidity and mortality. In addition, frail kidney failure patients have higher hospitalization and mortality rates as compared with other kidney failure patients. Evidence suggests that assessment and recommendations for physical activity should be part of standard care for kidney failure patients. Structured exercise can improve physical function and quality of life in frail older adults and may be used specifically for management of frailty in kidney failure. However, research is needed to determine best practices for implementation of physical function measurements and physical activity promotion in standard kidney failure care. Objective: The proposed Move More study will assess the feasibility of a physical activity intervention offered to the kidney failure inpatients in Calgary, Alberta. Specifically, this study is designed to examine the effects of an early physical activity/mobility intervention led by a kinesiologist, and supported by the clinical care team including physiotherapists (PT) and nurse clinicians. Methods: The Move More study is a single-arm pilot intervention examining feasibility and optimal improvement in real-world conditions. Kidney failure inpatients at the Foothills Medical Centre will be recruited to participate. Patients will receive an individualized in-hospital physical activity/mobility intervention. Frailty and physical function will be assessed at baseline and postintervention prior to hospital discharge. The goal is to recruit 24 to 36 patients. Conclusions: Evidence needed to support the inclusion of mobility and physical activity as part of standard care will be gathered, with knowledge gained used to help direct future physical activity programming for kidney failure inpatients.


2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Nduka C. Okwose ◽  
Leah Avery ◽  
Nicola O’Brien ◽  
Sophie Cassidy ◽  
Sarah J. Charman ◽  
...  

Abstract Purpose Less than 10% of heart failure patients in the UK participate in cardiac rehabilitation programmes. The present pilot study evaluated feasibility, acceptability and physiological effects of a novel, personalised, home-based physical activity intervention in chronic heart failure. Methods Twenty patients (68 ± 7 years old, 20% females) with stable chronic heart failure due to reduced left ventricular ejection fraction (31 ± 8 %) participated in a single-group, pilot study assessing the feasibility and acceptability of a 12-week personalised home-based physical activity intervention aiming to increase daily number of steps by 2000 from baseline (Active-at-Home-HF). Patients completed cardiopulmonary exercise testing with non-invasive gas exchange and haemodynamic measurements and quality of life questionnaire pre- and post-intervention. Patients were supported weekly via telephone and average weekly step count data collected using pedometers. Results Forty-three patients were screened and 20 recruited into the study. Seventeen patients (85%) completed the intervention, and 15 (75%) achieved the target step count. Average step count per day increased significantly from baseline to 3 weeks by 2546 (5108 ± 3064 to 7654 ± 3849, P = 0.03, n = 17) and was maintained until week 12 (9022 ± 3942). Following completion of the intervention, no adverse events were recorded and quality of life improved by 4 points (26 ± 18 vs. 22 ± 19). Peak exercise stroke volume increased by 19% (127 ± 34 vs. 151 ± 34 m/beat, P = 0.05), while cardiac index increased by 12% (6.8 ± 1.5 vs. 7.6 ± 2.0 L/min/m2, P = 0.19). Workload and oxygen consumption at anaerobic threshold also increased by 16% (49 ± 16 vs. 59 ± 14 watts, P = 0.01) and 10% (11.5 ± 2.9 vs. 12.8 ± 2.2 ml/kg/min, P = 0.39). Conclusion The Active-at-Home-HF intervention is feasible, acceptable and effective for increasing physical activity in CHF. It may lead to improvements in quality of life, exercise tolerance and haemodynamic function. Trial Registration www.clinicaltrials.gov NCT0367727. Retrospectively registered on 17 September 2018.


2019 ◽  
Vol 29 (3) ◽  
pp. 531-540 ◽  
Author(s):  
Dimitrios A Koutoukidis ◽  
Rebecca J Beeken ◽  
Ranjit Manchanda ◽  
Matthew Burnell ◽  
Nida Ziauddeen ◽  
...  

ObjectivesTo explore the effectiveness of a theory-based behavioral lifestyle intervention on health behaviors and quality of life in endometrial cancer survivors.’MethodsThis was a secondary analysis of a randomized controlled pilot trial conducted in two UK hospitals enrolling disease-free stage I-IVA endometrial cancer survivors. Participants were allocated to an 8-week group-based healthy eating and physical activity intervention or usual care using 1:1 minimization. Participants were followed up at 8 and 24 weeks, with the 8-week assessment being blinded. Diet, physical activity, and quality of life were measured with the Alternative Healthy Eating Index 2010, Stanford 7-Day Physical Activity Recall, and the EORTC Quality of life Questionnaire Core 30, respectively. We analyzed all eligible participants using the intention-to-treat approach in complete cases, adjusting for baseline values, body mass index, and age.ResultsWe enrolled 60 of the 296 potentially eligible endometrial cancer survivors (May - December 2015). Fifty-four eligible participants were randomized to the intervention (n=29) or usual care (n=31), and 49 had complete follow-up data (n=24 in the intervention and n= 25 in usual care). Intervention adherence was 77%. At 8 weeks, participants in the intervention improved their diet compared to usual care (difference in Alternative Healthy Eating Index 2010 score 7.5 (95% CI: 0.1 to 14.9), P=0.046) but not their physical activity (0.1 metabolic equivalent-h/day 95% CI: (-1.6 to 1.8), P=0.879), or global quality of life score (5.0 (95% CI: -3.4 to 13.3), P=0.236). Global quality of life improved in intervention participants at 24 weeks (difference 8.9 (95% CI: 0.9 to 16.8), P=0.029). No intervention-related adverse events were reported.ConclusionsThe potential effectiveness of the intervention appeared promising. A future fully-powered study is needed to confirm these findings.Trial registration numberNCT02433080.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Rathi Ramji ◽  
Elisabeth Carlson ◽  
Anders Kottorp ◽  
Sergey Shleev ◽  
Eman Awad ◽  
...  

Abstract Background Despite numerous interventions aiming to improve physical activity in socially disadvantaged populations, physical inactivity remains to be a rising challenge to public health globally, as well as, in Sweden. In an effort to address this challenge, a community-based participatory intervention was developed through active community engagement and implemented in a socially disadvantaged neighborhood in Sweden. The current study aims to present the development and initial evaluation of a participatory research driven physical activity intervention. Methods Fifteen participants (11 females and 4 males) aged 17–59 years volunteered to participate in the physical activity intervention program. The intervention program was evaluated using a longitudinal mixed methods design measuring health impact changes over time through focus group discussions and quality of life surveys. Further additional biomedical health parameters such as levels of glycosylated hemoglobin, blood pressure, levels of oxygen saturation and body mass index were monitored before and after the intervention. Focus group data were analyzed using content analysis with an inductive approach. The pre-and post-test scores from the survey-based quality of life domains, as well as the health parameters were compared using non-parametric and parametric statistics. Results Four themes emerged from the analysis of the focus group discussions including sense of fellowship, striving for inclusion and equity, changing the learner perspective and health beyond illness. The scores for the domains Physical Health, Psychological Health, Social Relationships and Health Satisfaction where significantly higher after participation in the physical activity intervention program compared to the pre-test scores (p < .05)s. There were however, no significant changes in the scores for the environmental domain and overall quality of life after intervention compared to that prior to intervention start. Overall, the biomedical health parameters remained stable within the normal ranges during intervention. Conclusion The focus group discussions and results from the surveys and biomedical measures reveal important findings to understand and further develop the intervention program to promote health equity among citizens in disadvantaged areas. Evaluating the feasibility of such an intervention using multiple approaches contributes to effective implementation of it for larger communities in need.


2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Gill Hubbard ◽  
Claire Taylor ◽  
Angus J. M. Watson ◽  
Julie Munro ◽  
William Goodman ◽  
...  

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Michael C. Robertson ◽  
Elizabeth J. Lyons ◽  
Jaejoon Song ◽  
Matthew Cox-Martin ◽  
Yisheng Li ◽  
...  

2020 ◽  
Author(s):  
Kathryn Wytsma-Fisher ◽  
Stefan Mustata ◽  
Theresa Cowan ◽  
Manuel Ester ◽  
S. Nicole Culos-Reed

Background: Low physical activity levels and poor physical functioning are strongly associated with poor clinical outcomes and mortality in adult End Stage Kidney Disease (ESKD) patients, regardless of treatment modality. Compared to the general population, individuals with chronic kidney disease are physically inactive, have reduced physical abilities and difficulties performing routine daily tasks, lower health-related quality of life, higher cardiovascular morbidity and mortality. In addition, frail ESKD patients have higher hospitalization and mortality rates than other ESKD patients. Evidence suggests that assessment and recommendations for physical activity should be part of standard care for ESKD patients. Structured exercise can improve physical function and quality of life in frail older adults and may be used specifically for management of frailty in ESKD. However, research is needed to determine best practices for implementation of physical function measurements and physical activity promotion in standard ESKD care. Objective: The proposed Move More study will assess the feasibility of a physical activity intervention offered to the ESKD inpatients in Calgary, Alberta. Specifically, this study is designed to examine the effects of an early physical activity/mobility intervention led by a kinesiologist (KT), and supported by the clinical care team including physiotherapists (PT) and nurse clinicians.Methods: The Move More study is a single-arm pilot intervention examining feasibility and preliminary efficacy. ESKD inpatients at the Foothills Medical Centre will be recruited to participate. Patients will receive an individualized in-hospital physical activity/mobility intervention. Frailty and physical function will be assessed at baseline and post-intervention prior to hospital discharge. Conclusions: Evidence needed to support the inclusion of mobility and physical activity as part of standard care will be gathered, with knowledge gained used to help direct future physical activity programming for ESKD inpatients.


2020 ◽  
Author(s):  
Rathi Ramji ◽  
Elisabeth Carlson ◽  
Anders Kottorp ◽  
Sergey Shleev ◽  
Eman Awad ◽  
...  

Abstract Background: Despite numerous interventions aiming to improve physical activity in socially disadvantaged populations, physical inactivity remains to be a rising challenge to public health globally, as well as, in Sweden. In an effort to address this challenge, a community-based participatory intervention was developed through active community engagement and implemented in a socially disadvantaged neighborhood in Sweden. The current study aims to present the development and initial evaluation of a participatory research driven physical activity intervention. Methods : Fifteen participants (11 females and 4 males) aged 17-59 years volunteered to participate in the physical activity intervention program. The intervention program was evaluated using a longitudinal mixed methods design measuring health impact changes over time through focus group discussions and quality of life surveys. Further additional biomedical health parameters such as levels of glycosylated hemoglobin, blood pressure, levels of oxygen saturation and body mass index were monitored before and after the intervention. Focus group data were analyzed using content analysis with an inductive approach. The pre-and post-test scores from the survey-based quality of life domains, as well as the health parameters were compared using non-parametric and parametric statistics. Results : Four themes emerged from the analysis of the focusgroup discussions including sense of fellowship, striving for inclusion and equity, changing the learner perspective and health beyond illness. The scores for the domains Physical Health, Psychological Health, Social Relationships and Health Satisfaction where significantly higher after participation in the physical activity intervention program compared to the pre-test scores ( p <.05)s. There were however, no significant changes in the scores for the environmental domain and overall quality of life after intervention compared to that prior to intervention start. Overall, the biomedical health parameters remained stable within the normal ranges during intervention. Conclusion : The focusgroup discussions and results from the surveys and biomedical measures reveal important findings to understand and further develop the intervention program to promote health equity among citizens in disadvantaged areas. Evaluating the feasibility of such an intervention using multiple approaches contributes to effective implementation of it for larger communities in need.


2018 ◽  
Author(s):  
Lidia Delrieu ◽  
Vincent Pialoux ◽  
Olivia Pérol ◽  
Magali Morelle ◽  
Agnès Martin ◽  
...  

BACKGROUND There is limited knowledge regarding the potential benefits of physical activity in patients with metastatic breast cancer. OBJECTIVE The Advanced stage Breast cancer and Lifestyle Exercise (ABLE) Trial aimed to assess the feasibility of a physical activity intervention in women with metastatic breast cancer and to explore the effects of physical activity on functional, psychological, and clinical parameters. METHODS The ABLE Trial was a single-arm, 6-month intervention study with a home-based, unsupervised, and personalized walking program using an activity tracker. At baseline and 6 months, we assessed anthropometrics, functional fitness, physical activity level, sedentary behavior, quality of life, fatigue, and tumor progression. Paired proportions were compared using the McNemar test and changes of parameters during the intervention were analyzed using the Wilcoxon signed-rank test, the Mann-Whitney test, and Spearman rank correlations. RESULTS Overall, 49 participants (mean age 55 years; recruitment rate 94%) were enrolled and 96% adhered to the exercise prescription (attrition rate 2%). Statistically significant improvements in the 6-minute walking distance test (+7%, <i>P</i>&lt;.001) and isometric quadriceps strength (+22%, <i>P</i>&lt;.001), as well as decreases in body mass index (-2.5%, <i>P</i>=.03) and hip circumference (-4.0%, <i>P</i>&lt;.001) were observed at 6 months. Quality of life remained stable and a nonstatistically significant decrease (-16%, <i>P</i>=.07) in fatigue was observed. CONCLUSIONS The high recruitment and adherence rates suggest the willingness of patients with metastatic breast cancer to participate in a physical activity program. The beneficial outcomes regarding physical fitness and anthropometry of this unsupervised physical activity program may encourage these patients to maintain a physically active lifestyle. Future randomized controlled trials with larger sample sizes are warranted. CLINICALTRIAL ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886 INTERNATIONAL REGISTERED REPORT RR2-10.2196/10487


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