Can exercise influence survival following breast cancer: Results from a randomised, controlled trial.

10067 Background: Exercise for Health was a randomised, controlled trial designed to evaluate an 8-month translational exercise intervention, commencing 6-weeks post-surgery for newly diagnosed breast cancer. Outcomes for this follow-up exploratory analysis were overall- and disease-free survival. Methods: Consenting urban-based women (n = 194) were randomized to one of two exercise groups (intervention delivered either face-to-face or over the telephone) or a usual care group, while consenting rural/regional women (n = 143) were randomised to either the telephone-delivered exercise group or usual care group. For the purposes of these analyses, exercise groups and usual care groups were combined (exercise group, n = 207; usual care group, n = 130). Analyses were done on an intention-to-treat basis and trials were registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000233527; 12609000809235). Results: Participant disease and treatment characteristics were similar to the wider breast cancer population in Queensland, Australia, and 42% of the sample resided in rural or regional areas. After a median follow-up of 101 months, there were 15/130 (11.5%) survival events in the usual care group, compared with 11/207 (5.3%) events in the exercise group. Disease-free events for the usual care versus exercise group were 23/130 (17.7%) and 25/207 (12.1%), respectively. The corresponding unadjusted hazard ratio for the exercise group for overall survival was 0.45 (95% CI = 0.21-0.97; p = 0.037), and for disease-free survival was 0.66 (95% CI = 0.38-1.17; p = 0.155). Conclusions: Epidemiological evidence consistently shows a positive relationship between physical activity and survival post-breast cancer, but is unable to establish causality. These exploratory findings suggest that an exercise intervention delivered during and beyond conventional treatment for breast cancer and that was designed to cater for all women, irrespective of place of residence and access to medical services, has clear potential to influence survival. Clinical trial information: ACTRN12606000233527; 12609000809235.

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Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial

Clinical Rehabilitation ◽

10.1177/0269215516661751 ◽

2016 ◽

Vol 31 (7) ◽

pp. 891-903 ◽

Cited By ~ 7

Author(s):

AJ Turton ◽

P Cunningham ◽

F van Wijck ◽

HJM Smartt ◽

CA Rogers ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Usual Care Group ◽

Controlled Trial ◽

Care Group ◽

Reach To Grasp ◽

Arm Pain ◽

Home Based ◽

Wolf Motor Function Test ◽

Randomised Controlled

Objective: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. Design: single-blind parallel group RCT. Participants: Residual arm deficit less than 12 months post-stroke. Interventions: Reach-to-Grasp training in 14 one-hour therapist’s visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Control: Usual care. Main Measures: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. Results: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. Conclusions: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

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Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial

BMJ ◽

10.1136/bmj.k3760 ◽

2018 ◽

pp. k3760 ◽

Cited By ~ 25

Author(s):

Nerys M Astbury ◽

Paul Aveyard ◽

Alecia Nickless ◽

Kathryn Hood ◽

Kate Corfield ◽

...

Keyword(s):

Weight Loss ◽

Usual Care ◽

Usual Care Group ◽

Practice Nurse ◽

Controlled Trial ◽

Care Group ◽

Metabolic Risk ◽

Behavioural Support ◽

Total Diet ◽

Randomised Controlled

Abstract Objective To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting. Design Pragmatic, two arm, parallel group, open label, individually randomised controlled trial. Setting 10 primary care practices in Oxfordshire, UK. Participants 278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months. Interventions The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction. Main outcome measures The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded. Results Participants in the TDR group lost more weight (−10.7 kg) than those in the usual care group (−3.1 kg): adjusted mean difference −7.2 kg (95% confidence interval −9.4 to −4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity. Conclusions Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease. Trial registration International Standard Randomised Controlled Trials No ISRCTN75092026 .

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MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2017-017540 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017540 ◽

Cited By ~ 22

Author(s):

Karla Santo ◽

Clara K Chow ◽

Aravinda Thiagalingam ◽

Kris Rogers ◽

John Chalmers ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Medication Adherence ◽

Randomised Controlled Trial ◽

Usual Care ◽

Usual Care Group ◽

Controlled Trial ◽

Care Group ◽

Randomised Controlled ◽

Medication Reminder

IntroductionThe growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence.Methods and analysisRandomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps.Ethics and disseminationEthical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums.Trial registration numberACTRN12616000661471; Pre-results

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Effects of Exercise on Biobehavioral Outcomes of Fatigue During Cancer Treatment

Biological Research For Nursing ◽

10.1177/1099800414523489 ◽

2014 ◽

Vol 17 (1) ◽

pp. 40-48 ◽

Cited By ~ 16

Author(s):

Sadeeka Al-Majid ◽

Lori D. Wilson ◽

Cyril Rakovski ◽

Jared W. Coburn

Keyword(s):

Breast Cancer ◽

Cancer Treatment ◽

Usual Care ◽

Inflammatory Markers ◽

Exercise Intervention ◽

Retention Rate ◽

Exercise Group ◽

Recruitment Rate ◽

Care Group ◽

Hb Concentration

Cancer treatment is associated with decreased hemoglobin (Hb) concentration and aerobic fitness (VO2 max), which may contribute to cancer-related fatigue (CRF) and decreased quality of life (QoL). Endurance exercise may attenuate CRF and improve QoL, but the mechanisms have not been thoroughly investigated. Objectives. To (a) determine the feasibility of conducting an exercise intervention among women receiving treatment for breast cancer; (b) examine the effects of exercise on Hb and VO2 maxand determine their association with changes in CRF and QoL; and (c) investigate changes in selected inflammatory markers. Methods. Fourteen women receiving chemotherapy for Stages I–II breast cancer were randomly assigned to exercise ( n = 7) or usual care ( n = 7). Women in the exercise group performed supervised, individualized treadmill exercise 2–3 times/week for the duration of chemotherapy (9–12 weeks). Data were collected 4 times over 15–16 weeks. Results. Recruitment rate was 45.7%. Sixteen women consented and 14 completed the trial, for a retention rate of 87.5%. Adherence to exercise protocol was 95–97%, and completion of data collection was 87.5–100%. Exercise was well tolerated. VO2 maxwas maintained at prechemotherapy levels in exercisers but declined in the usual-care group ( p < .05). Hb decreased ( p < .001) in all participants as they progressed through chemotherapy. Exercise did not have significant effects on CRF or QoL. Changes in inflammatory markers favored the exercise group. Conclusions. Exercise during chemotherapy may protect against chemotherapy-induced decline in VO2 maxbut not Hb concentration.

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Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

10.2196/preprints.36480 ◽

2022 ◽

Author(s):

Maryam Zahid ◽

Ume Sughra

Keyword(s):

Nutritional Status ◽

Usual Care ◽

Usual Care Group ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Care Group ◽

Randomized Controlled ◽

Nutritional Status Of Children ◽

Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

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The Natural History of Back Pain after a Randomised Controlled Trial of Acupuncture Vs Usual Care – Long Term Outcomes

Acupuncture in Medicine ◽

10.1136/aim.25.4.121 ◽

2007 ◽

Vol 25 (4) ◽

pp. 121-129 ◽

Cited By ~ 6

Author(s):

Stephanie L Prady ◽

Kate Thomas ◽

Lisa Esmonde ◽

Simon Crouch ◽

Hugh MacPherson

Keyword(s):

Back Pain ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Bodily Pain ◽

Care Group ◽

Long Term Outcomes ◽

Short Term Treatment ◽

Randomised Controlled

Introduction There is growing evidence about the effectiveness of acupuncture in the short term treatment of chronic low back pain but little is known about long term outcomes. To address this question we followed up participants of a past randomised controlled trial of acupuncture to assess outcomes after 5.5 to 7 years. Methods A postal questionnaire assessing pain, quality of life, disability, experience with back pain and healthcare resource use was sent to all 239 participants of the York Acupuncture for Back Pain trial. Results Response to the survey was low at 43.9%. Pain measured by the SF-36 Bodily Pain dimension was maintained in the acupuncture group since the last follow up 3.5 to 5 years previously. The usual care group had improved over the intervening years and there was now no evidence of a difference between the groups (difference −0.4 points, 95% confidence interval −10.1 to 9.7). The results were unchanged on sensitivity analysis using multiple imputation. In both groups back pain had not completely resolved and worry about back health was moderate. Physiotherapy and acupuncture were used at similar rates for continuing treatment. Discussion We theorise that exposure to a short course of acupuncture speeds natural recovery from a back pain episode, but improvements plateau after two years. Acupuncture is often accessed privately for long term management of back pain but is rarely available within the health service. While our study methods were robust, the low response rate means that our findings should be interpreted with caution.

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Protocol for a feasibility randomised controlled trial of a musculoskeletal exercise intervention versus usual care for children with haemophilia

BMJ Open ◽

10.1136/bmjopen-2019-029474 ◽

2019 ◽

Vol 9 (8) ◽

pp. e029474 ◽

Cited By ~ 2

Author(s):

Ferhana Hashem ◽

Melanie Bladen ◽

Liz Carroll ◽

Charlene Dodd ◽

Wendy I Drechsler ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Muscle Strength ◽

Usual Care ◽

Exercise Intervention ◽

Controlled Trial ◽

Small Scale ◽

Framework Analysis ◽

Muscle Strengthening ◽

Training Requirements ◽

Randomised Controlled

IntroductionHaemophilia is a rare, inherited disorder in which blood does not clot normally, resulting in bleeding into joints and muscles. Long-term consequence is disabling joint pain, stiffness, muscle weakness, atrophy and reduced mobility. The purpose of this proposed feasibility of a randomised controlled trial (RCT) is to test the feasibility of an age-appropriate physiotherapy intervention designed to improve muscle strength, posture and the way boys use their joints during walking and everyday activities.Methods and analysisA small-scale two-centre RCT of a 12-week muscle strengthening exercise intervention versus usual care for young children with haemophilia will be conducted. Primary outcomes will be safety and adherence to the exercise intervention. Secondary outcomes will include recruitment, retention and adverse event rates, clinical data, muscle strength, joint biomechanics and foot loading patterns during walking, 6 min timed walk, timed-up-and-down-stairs, EQ-5D-Y, participants’ perceptions of the study, training requirements and relevant costs. Recruitment, follow-up, safety and adherence rates will be described as percentages. Participant diary and interview data will be analysed using a framework analysis. Demographic and disease variable distributions will be analysed for descriptive purposes and covariant analysis. Estimates of differences between treatment arms (adjusted for baseline) and 75% and 95% CIs will be calculated.Ethics and disseminationThe study has ethical approval from the London—Fulham Research Ethics Committee (17/LO/2043) as well as Health Research Authority approval. As well as informing the design of the definitive trial, results of this study will be presented at local, national and international physiotherapy and haemophilia meetings as well as manuscripts submitted to peer-reviewed journals. We will also share the main findings of the study to all participants and the Haemophilia Society.

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Using Moxibustion in Primary Healthcare to Correct Non-Vertex Presentation: A Multicentre Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2012-010261 ◽

2013 ◽

Vol 31 (1) ◽

pp. 31-38 ◽

Cited By ~ 36

Author(s):

Jorge Vas ◽

José Manuel Aranda-Regules ◽

Manuela Modesto ◽

María Ramos-Monserrat ◽

Mercedes Barón ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Primary Healthcare ◽

Primary Outcome ◽

Controlled Trial ◽

Acupuncture Point ◽

Care Group ◽

Moxibustion Group ◽

Vertex Presentation ◽

Randomised Controlled

Objective To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. Methods This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33–35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. Results In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. Conclusions Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. Trial Registration Current Controlled Trials ISRCTN10634508.

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PERCEPT myeloma: a protocol for a pilot randomised controlled trial of exercise prehabilitation before and during autologous stem cell transplantation in patients with multiple myeloma

BMJ Open ◽

10.1136/bmjopen-2019-033176 ◽

2020 ◽

Vol 10 (1) ◽

pp. e033176

Author(s):

Orla McCourt ◽

Abigail Fisher ◽

Gita Ramdharry ◽

Anna L Roberts ◽

Joanne Land ◽

...

Keyword(s):

Stem Cell ◽

Randomised Controlled Trial ◽

Stem Cell Transplantation ◽

Usual Care ◽

Cell Transplantation ◽

Autologous Stem Cell Transplantation ◽

Exercise Intervention ◽

Controlled Trial ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

IntroductionMyeloma, a blood cancer originating from plasma cells, is the most common indication for autologous stem cell transplantation (SCT). Patients with myeloma undergoing autologous SCT (ASCT) experience treatment-related morbidity and reduction in function and well-being for many months post-treatment. Interventions targeting physical functioning delivered prior to and during SCT have shown promising results in mixed haematological populations and may offer a non-pharmacological solution to physically optimising and preparing patients for SCT. The aim of this study is to investigate the feasibility of a physiotherapist-led exercise intervention as an integral part of the myeloma ASCT pathway at a UK tertiary centre.Methods and analysisPERCEPT is a single-site, pilot randomised controlled trial of an exercise intervention embedded within the myeloma ASCT pathway, compared with usual care. The primary study end points will be feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events. Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity. Outcomes will be assessed at four time points, approximately 6–8 weeks prior to SCT, on/around day of SCT, on discharge from SCT hospital admission and 12 weeks post-discharge. The exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques to promote change in exercise behaviour. The primary outcomes from the trial will be summarised as percentages or mean values with 95% CIs. Group differences for secondary outcomes at each time point will be analysed using appropriate statistical models.Ethics and disseminationThis study has NHS REC approval (Camden and Kings Cross, 19/LO/0204). Results will be disseminated through publication and presentations at haematology and rehabilitation-related meetings.Trial registration numberISRCTN15875290.

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Use of a web-based app to improve breast cancer symptom management and aromatase inhibitor adherence.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.5_suppl.89 ◽

2017 ◽

Vol 35 (5_suppl) ◽

pp. 89-89 ◽

Cited By ~ 1

Author(s):

Ilana Graetz ◽

Caitlin N McKillop ◽

Edward J. Stepanski ◽

Gregory A. Vidal ◽

Lee Steven Schwartzberg

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Usual Care ◽

Hormone Receptor ◽

Usual Care Group ◽

Care Group ◽

Short Term ◽

Hormone Receptor Positive ◽

Positive Breast Cancer

89 Background: For postmenopausal women with hormone receptor-positive breast cancer, long-term use of aromatase inhibitors (AI) significantly reduces the risk of cancer recurrence and improves disease free and overall survival. Despite the known benefits of AIs, many patients are nonadherent due to adverse side effects. We conducted a pilot randomized controlled trial of a web-enabled application (app) to provide real-time monitoring and better management of treatment-related adverse symptoms among patients with hormone-receptor positive breast cancer and a new AI prescription. Methods: Eligible patients who agreed to participate were randomized into either: App: had access to the app and received weekly reminders to use it; or Usual Care: had access to the app but did not receive reminders. Concerning responses and trends triggered email alerts to the patient’s providers, who then could review responses to manage ongoing treatment and make therapeutic adjustments. The main analyses compared overall AI adherence using the Morisky Medication Adherence Scale and quality of life using the Functional Assessment of Cancer Therapy Endocrine Symptoms (FACT-ES). Results: We enrolled 44 patients, 21 in the App and 23 in the Usual Care groups; 83% of patients approached agreed to participate, 23% were African-American, and 32% were over the age of 65. Overall, 74% of participants in the App group used the app at least once per week compared with 38% in the Usual Care group (p<0.01). Reported AI adherence at 8 weeks after initiation was significantly higher among App compared with the Usual care group at 8 weeks (100% vs. 72%, p=0.01). Using a differences-in-differences analysis, we found a substantially larger decrease in quality of life in the Usual Care group compared with the App (-11.5 vs. -3.9, p=0.191), although this difference did not reach statistical significance. Conclusions: App use with weekly reminders significantly improved short-term AI adherence. If short-term gains in adherence persist, this low-cost intervention could improve survival outcomes for women with hormone-receptor positive breast cancer.

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