scholarly journals The feasibility of recruiting patients with early COPD to a pilot trial assessing the effects of a physical activity intervention

2010 ◽  
Vol 19 (2) ◽  
pp. 124-130 ◽  
Author(s):  
James Faulkner ◽  
Emily Walshaw ◽  
John Campbell ◽  
Rupert Jones ◽  
Rod Taylor ◽  
...  
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.


Author(s):  
Marissa A. Kobayashi ◽  
Sara M. St. George ◽  
Rafael O. Leite ◽  
Blanca Noriega Esquives ◽  
Rachel Wetstone ◽  
...  

Physical inactivity is a major public health issue among older adults and children. This study presents preliminary results that will inform the development of a technology-based physical activity intervention for grandparents and grandchildren (ages 6–12 years old). The authors used an iterative user-centered design framework to gather quantitative data from grandparents (n = 35) and subsequently invited a subset of 12 of them to engage in qualitative interviews. Participants were 63.1 ± 9.8 years old, 80% female, 64% U.S.-born, 43% Hispanic, 66% single, and 40% <$15K income. The majority of grandparents reported mobile device proficiency, very close relationships with their grandchildren, and interest in participating in an intergenerational intervention. Four key themes related to family closeness, dynamics, routines, and technology informed intervention development. Next steps involved a pilot trial using Fitbits and a fully functioning technology-based prototype. Grandparents are uniquely positioned within their families to serve as agents of change in health-promoting interventions.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Angus A. Leahy ◽  
Sarah G. Kennedy ◽  
Jordan J. Smith ◽  
Narelle Eather ◽  
James Boyer ◽  
...  

Abstract Background Adolescents with disability are less active and have lower levels of physical fitness than their typically developing peers. Schools are ideal settings to address this; however, few school-based interventions have been designed and evaluated among this group. Therefore, the aim of this pilot study was to determine the feasibility of a time-efficient school-based physical activity intervention for adolescents with disability. Methods A non-randomized pilot trial was conducted with adolescents in the special education unit at one secondary school in New South Wales, Australia. Sixteen grade 11 and 12 students (aged 17.3 ± 0.7 years) participated in the 2-month physical activity intervention. Two classroom teachers were trained to facilitate the delivery of a high-intensity interval training (HIIT) program, known as Burn 2 Learn adapted (B2La). Teachers were asked to deliver 2–3 weekly HIIT sessions for a period of 2 months. Four domains of feasibility (acceptability, implementation, adaptability, and practicality) were assessed using quantitative measures at the student and teacher levels (e.g., observations, process evaluation questionnaires, and heart rate [HR] monitoring). Data were also collected from three learning and support teachers who assisted classroom teachers with intervention delivery. Preliminary efficacy of the intervention on measures of adolescents’ functional capacity (6-min walk/run test) and muscular fitness (sit-to-stand test and modified push-up test) were analyzed using paired sample t-tests. Results Moderate-to-high levels of program satisfaction were reported by both students (80% rated “Good” or “Excellent”) and teachers (100% rated “Good” or “Excellent”). Teachers reported delivering 2.5 ± 0.7 sessions per week during the study. Based on researcher session observations, the program was delivered effectively by teachers (14/20). However, HR data indicated session intensity was lower than intended. The program was considered “adaptable” by teachers, with several observed modifications to HIIT sessions to cater for the needs of adolescents with disability. No adverse events were reported. We observed improvements in preliminary efficacy measures. Conclusions Our findings suggest it is feasible to train teachers to deliver a school-based HIIT program for adolescents with disability. Evaluation of B2La within a larger-scale effectiveness trial is warranted. Trial registration ACTRN12621000219886.


2010 ◽  
Vol 15 (6) ◽  
pp. 646-659 ◽  
Author(s):  
Emily L. Mailey ◽  
Thomas R. Wójcicki ◽  
Robert W. Motl ◽  
Liang Hu ◽  
David R. Strauser ◽  
...  

Author(s):  
Geraldine Wallbank ◽  
Catherine Sherrington ◽  
Leanne Hassett ◽  
Dominika Kwasnicka ◽  
Josephine Y Chau ◽  
...  

Abstract Regular physical activity benefits health across the lifespan. Women in middle-age often juggle carer and work responsibilities, are often inactive, and may benefit from tailored support to increase physical activity. Establish the acceptability, feasibility, and impact on physical activity of a scalable program for women 50+ years. This pilot trial randomized participants to immediate program access, or to a wait-list control. [Active Women over 50 Online] program included: (1) study-specific website, (2) 8 emails or 24 SMS motivation-based messages, (3) one telephone health-coaching session. Outcomes, at 3 months, were acceptability (recommend study participation, intervention uptake), feasibility (recruitment, reach, completion), intervention impact (physical activity), intervention impressions. At baseline, 62 participants of mean (SD) age 59 (±7) years took 7459 (±2424) steps/day and most (92%) reported ≥2 medical conditions. At 3 months, acceptability and impact data were available for 52 (84%) and 57 (92%) participants, respectively. Study participation was recommended by 83% of participants. Participants mostly agreed to receive health coaching (81%) and messages (87%: email = 56%, SMS = 44%), opened 82% of emails and accessed the website 4.8 times on average. Respondents reported the intervention supported their physical activity. Intervention participants were more likely to increase steps from baseline by 2000+/day (OR: 6.31, 95% CI: 1.22 to 32.70, p = .028) than controls, and trended toward more light-intensity (p = .075) and moderate-vigorous intensity physical activity (p = .11). The [Active Women over 50 Online] program demonstrated acceptability and feasibility among the target population, and effectiveness in some domains in the short term. Results warrant further testing in a full-scale RCT.


2017 ◽  
Author(s):  
Britta Larsen ◽  
Tanya Benitez ◽  
Mayra Cano ◽  
Shira S Dunsiger ◽  
Bess H Marcus ◽  
...  

BACKGROUND Physical activity is markedly low in Latina adolescents, yet few physical activity interventions have been attempted in this population. Web-based interventions can incorporate theory-based components, be appealing to adolescents, and have potential for low-cost dissemination. OBJECTIVE This study aimed to assess the feasibility, acceptability, and potential efficacy of a Web-based physical activity intervention for Latina adolescents in a single-arm pilot trial. METHODS A total of 21 Latina adolescents (aged 12-18 years) who could read and write in English and were underactive (<90 min/week) participated in a 12-week, theory-informed Web-based physical activity intervention. The intervention website was modified from a previous Web-based intervention for Latina adults. Web content was individually tailored based on the responses to monthly questionnaires. Feasibility was measured by recruitment, retention, and adherence/engagement, and acceptability was measured by satisfaction surveys. Physical activity was measured at baseline and follow-up (12 weeks) using the 7-day physical activity recall (PAR) interview and accelerometers. RESULTS Baseline activity as measured by the 7-day PAR and accelerometers was 24.7 (SD 26.11) and 24.8 (SD 38.3) min/week, respectively. At 12 weeks, 19 participants (90%, 19/21) returned. Adherence and engagement with materials were low, but 72% (15/21) of the participants indicated that they were satisfied with the intervention. Activity at 12 weeks increased by 58.8 (SD 11.33) min/week measured by the 7-day PAR (P<.001). Accelerometer-measured activity did not increase. Activities reported at follow-up were more varied than at baseline, including some activities measured poorly by accelerometers (eg, biking and swimming). Participants suggested simplifying the website and incorporating other technologies. CONCLUSIONS Good retention and increases in self-reported activity suggest a promising approach to delivering a physical activity intervention to Latina adolescents. Incorporating other technologies, such as smartphone apps, could make the intervention more engaging, acceptable, and effective.


2020 ◽  
Author(s):  
Britta Larsen ◽  
Stephanie Micucci ◽  
Sheri J Hartman ◽  
Gladys Ramos

BACKGROUND Diabetes during pregnancy poses serious health risks to both mother and child. Regular physical activity can reduce these risks, yet few clinic-based interventions of physical activity for pregnant women with diabetes have been attempted. OBJECTIVE The purpose of this single-arm pilot trial is to assess the feasibility and acceptability, and explore the potential efficacy of a counseling- and mobile health–based physical activity intervention for pregnant women with diabetes. METHODS Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program. Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician. They were given a Fitbit and shown how to use the Fitbit app, including entering personalized step goals, and were encouraged to build up to 10,000 daily steps. Daily steps were recorded for 12 weeks, until they were 36 weeks’ gestation, or until 1 week before they gave birth, whichever came first. Feasibility was measured by recruitment, retention, and adherence, and acceptability was measured using consumer satisfaction questionnaires and follow-up interviews. Potential efficacy was explored by examining changes in daily steps over time. RESULTS The participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71%). Of the 17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention. Adherence in wearing the Fitbit was relatively high, with a median wear adherence of 90% of days. The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall. Mean daily steps increased from baseline (mean 6122, SD 2439) to week 3 (mean 6269, SD 2166) and then decreased through week 12 (mean 4191, SD 2228). CONCLUSIONS High acceptability, retention, and adherence suggest that this may be a promising approach to delivering a simple, low-burden intervention in a clinical setting to a high-risk, underserved population. A randomized controlled trial is needed to determine whether this approach is effective in slowing the reduction in activity typically seen throughout pregnancy. CLINICALTRIAL ClinicalTrials.gov NCT03302377; https://clinicaltrials.gov/ct2/show/NCT03302377


2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 166-166 ◽  
Author(s):  
Erin Van Blarigan ◽  
Katherine Van Loon ◽  
Stacey A. Kenfield ◽  
June M Chan ◽  
Yoshimi Fukuoka ◽  
...  

166 Background: Colorectal cancer (CRC) survivors can improve their quality-of-life (QOL), and potentially survival, by engaging in physical activity. The aim of this pilot randomized controlled trial (RCT) is to determine the feasibility of a technology-based physical activity intervention for CRC survivors. Methods: 40 CRC survivors will be randomized (1:1) to a 12-week physical activity intervention (Fitbit Flex, daily text messages) or usual care. Eligible individuals must: 1) have stage I-III colon or rectal adenocarcinoma; 2) have completed therapy; 3) be considered cancer-free; 4) be English speaking; 5) have no contraindications to moderate physical activity; 6) engage in < 150 min/week of moderate physical activity; and 7) have Internet and a phone that can receive text messages. Our primary outcomes are adherence (e.g., Fitbit wear time, text response rate) and acceptability assessed via survey. Secondary outcomes include change in physical activity via 7-days of ActiGraph GT3X+ accelerometers and QOL. Results: We have screened 350 individuals with stage I-III CRC at the University of California, San Francisco (UCSF) for eligibility. Of these, 181 (52%) were not eligible [non-English speaking (46%), ≥ 150 min/week of physical activity (22%), contraindications to physical activity (22%), not cancer-free (7%), did not own a mobile phone (2%)]. We invited the remaining 169 eligible CRC survivors to participate by mail, e-mail, phone, or in clinic; 76 (45%) actively declined and 59 (35%) did not respond after up to 3 contact efforts. As of October 2016, 34 CRC survivors have been randomized to intervention (n = 16) or control (n = 18). These individuals are: 55% female; 64% Non-Hispanic White; 73% have a 4-y college degree; and 64% work full-time. The median (IQR) age and BMI are: 56 (50, 65) y and 26.4 (23.2, 32.4) kg/m2, respectively. Conclusions: The results of this pilot study will inform a definitive RCT to determine whether a technology-based physical activity intervention improves QOL and survival after CRC diagnosis. Funding: This research was supported by the NIH (K07CA197077, KL2TR000143), Mt. Zion Health Fund and UCSF Helen Diller Family Comprehensive Cancer Center.


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