Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer.
Ontology highlight
ABSTRACT: Background
Exercise may improve clinical and quality of life outcomes for men with prostate cancer. No randomized controlled trials (RCTs) have examined the feasibility, safety, and acceptability of remote exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC).Methods
We conducted a pilot RCT (1:1:1 aerobic or resistance exercise 3x/week or usual care) to determine the feasibility, safety, and acceptability of remotely monitored exercise over 12 weeks in 25 men with mCRPC. A prescribed exercise program was based on baseline testing including high- and moderate-intensity aerobic exercise or resistance exercise completed at a local exercise facility. Feasibility was based on attendance, adherence, and tolerance; safety on adverse events; and acceptability on participant interviews.Results
Between March 2016 and March 2020, 25 patients were randomized (8 aerobic, 7 resistance, and 10 control). Twenty-three men (82%) completed the 12-week study. Men who completed the remote intervention attempted 90% and 96% of prescribed aerobic and resistance training sessions, respectively, and 86% and 88% of attempted sessions were completed as or more than prescribed. We observed changes in performance tests that corresponded with the exercise prescription. No safety concerns were identified. Ninety percent of participants interviewed were satisfied with the program and would recommend it to others.Conclusions
Remotely monitored exercise training is feasible, safe, and acceptable in men with mCRPC; there was no difference in these outcomes by mode of exercise. Through this research, we provide direction and rationale for future studies of exercise and clinical outcomes in patients with metastatic prostate cancer.
SUBMITTER: Kenfield SA
PROVIDER: S-EPMC8607248 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundIn recent years, several studies have consistently reported the beneficial effects of aerobic exercise in alleviating symptoms following concussion. However, exercise modality recommendations by practitioners are often limited to traditional exercise equipment (eg, treadmills and stationary bikes). Advances in digital technologies may help to overcome this limitation, as mobile apps can now provide users with high-quality instructional videos, programs, and monitoring capabilities using alternative modalities such as resistance exercises. Mobile technologies are also rapidly expanding to deliver and complement in-person clinical care. Thus, it is imperative to evaluate this emerging technology on its feasibility, safety, and clinical utility for concussion care.ObjectiveThe objective of the study was to determine the feasibility of a mobile app to deliver a resistance exercise protocol with minimal equipment to individuals following concussion. Feasibility was defined by retention, adverse events, and achievement of a target heart rate (HR) of 60%±5% (age-adjusted percentage of max: 220 - age). HR data were collected using an Apple Watch, Series 6. Symptoms were evaluated before and after 3 exercise sessions.MethodsA 2-week, prospective, single-arm pilot study was conducted on 21 adults diagnosed with a concussion. Users were provided a continuous aerobic resistance exercise (CARE) protocol through a mobile app.ResultsA total of 18 participants (14 female and 4 male) completed a 3-session exercise plan. The median age-adjusted percent of HR max for session 1 was 55.5% (IQR 49%-63%), 58.1% (IQR 50.8%-65.2%) for session 2, and 57.4% (IQR 49.5%-64.7%) for session 3. Individual median HR% across all sessions ranged from 46.9% to 67.4%; furthermore, 10 participants (55.5%) had a total mean HR% within the target HR%, 7 participants had a mean HR% below 55%, and 1 participant had a mean HR% above 65%. In addition, adherence to the plan resulted in a decrease in reported symptom burden with 94% posterior probability.ConclusionsFollowing concussion, a CARE protocol delivered through a mobile app resulted in no adverse effects with 14% (n=3/21) attrition over 3 sessions. CARE was successful in achieving an aerobic exercise intensity of 55%-65% of age-adjusted maximum HR in the majority of participants and resulted in a decrease in reported symptom burden. The potential for this platform in concussion rehabilitation warrants further investigation. Future studies are needed to assess the use of this technology throughout concussion recovery in both individuals with acute concussion, and those with persistent symptoms.
| S-EPMC10337420 | biostudies-literature
Project description:BackgroundMen with metastatic castrate-resistant prostate cancer can experience an array of treatment-related side effects. Accumulating evidence suggests exercise may alleviate some of these adversities and assist in disease management. However, empirical evidence in advanced prostate cancer patients remains limited. The purpose of this study is to determine whether men with metastatic prostate cancer, who are ineligible for high-intensity exercise, can partake in a home-based, moderate-intensity exercise program and the impact of doing so on quality of life and physical fitness parameters.MethodsThirty men with adenocarcinoma of the prostate and progressive systemic, metastatic disease will be recruited. Clinicians will screen patients against inclusion criteria to determine eligibility. All men enrolled will be prescribed a tailored, home-based, moderate-intensity exercise intervention consisting of aerobic and strengthening components for 12 weeks. Patients will receive supplementary education materials and weekly behavioural change consultations throughout the intervention. The primary outcome will be the feasibility of delivering such an intervention in men with metastatic disease. Secondary endpoints including skeletal events will be monitored for safety, as will the feasibility of patient-reported outcome measures and the sampling time points, generating data pertaining to completion rates and potential effect in future trials. General physical fitness will be assessed during these visits, using timed sit-to-stand testing and a 6-min walking test. Prior to each visit, objective physical activity levels will be captured for 7 days using an accelerometer, to determine the feasibility of this technology and the quality of data obtained. In parallel with the feasibility aspects of the trial, changes compared to baseline will be reported. Direct regular contact will also serve as a feedback loop, should any issues arise. This study has received ethical approval from the Office for Research Ethics Committees Northern Ireland.ConclusionsThis study aims to determine the potential utility of a home-based exercise intervention in managing side effects associated with advanced prostate cancer and its treatment. This feasibility trial will inform the design and implementation of a larger randomised control trial to determine the efficacy of moderate aerobic and strengthening exercise as an adjuvant therapy in men with metastatic prostate cancer. Collecting such evidence provides further support for exercise in this paradigm and potential for its inclusion as a low-toxicity therapy in standard cancer care, in the longer term.Trial registrationClinicalTrials.gov, NCT03658486Trial sponsor: Queen's University Belfast (Reference: B18/15). Contact: Dr. Paula Tighe, Research and Enterprise, Queen's University Belfast. Telephone: 02890 973,296. Email: p.tighe@qub.ac.uk. The sponsor reviewed the protocol and ethical application prior to submission.Protocol issue: Version 1 (18th May 2018). Authors: MB, MM, SJ and GP.
| S-EPMC6696674 | biostudies-literature
Project description:This Letter investigated the efficacy of a decision-support system, designed for respiratory medicine, at predicting asthma exacerbations in a multi-site longitudinal randomised control trial. Adherence to inhaler medication was acquired over 3 months from patients with asthma employing a dose counter and a remote monitoring adherence device which recorded participant's inhaler use: n = 184 (23,656 audio files), 61% women, age (mean ± sd) 49.3 ± 16.4. Data on occurrence of exacerbations was collected at three clinical visits, 1 month apart. The relative risk of an asthma exacerbation for those with good and poor adherence was examined employing a univariate and multivariate modified Poisson regression approach; adjusting for age, gender and body mass index. For all months dose counter adherence was significantly (p < 0.01) higher than remote monitoring adherence. Overall, those with poor adherence had a 1.38 ± 0.34 and 1.42 ± 0.39 (remotely monitored) and 1.25 ± 0.32 and 1.18 ± 0.31 (dose counter) higher relative risk of an exacerbation in model 1 and model 2, respectively. However, this was not found to be statistically significantly different. Remotely monitored adherence holds important clinical information and future research should focus on refining adherence and exacerbation measures. Decision-support systems based on remote monitoring may enhance patient-physician communication, possibly reducing preventable adverse events.
| S-EPMC4814807 | biostudies-literature
Project description:Cognitive remediation (CR) is an evidence-based therapy used to improve cognition in people with schizophrenia. However, it often requires multiple in-person clinic sessions per week, which can limit scalability. This mixed methods study considered the feasibility and acceptability of a hybrid approach, which allowed for half the sessions to be conducted remotely as homework, without the clinician present. Individuals with schizophrenia were randomized to either all in-clinic or hybrid conditions and completed questionnaires and individual interviews about their experience. CR clinicians provided feedback in complement. Because of limited access to technology, most Hybrid CR participants had to come to clinic to access computers and often sought clinician support to do their homework. Participants in the two conditions were equally satisfied per the Client Satisfaction Questionnaire, and the majority reported perceived benefit and enjoyment. Both CR participants and clinicians identified access to technology as a barrier to program feasibility, while availability of clinician support positively impacted acceptability. Suggestions to improve CR highlighted adopting a flexible approach to providing CR that accounts for participant access to technology, potential benefit from peer interaction, and need for clinician support.
| S-EPMC8206004 | biostudies-literature
Project description:BackgroundBaduanjin is a traditional Chinese exercise regimen used to treat various chronic illnesses and is associated with both psychological and physical benefits. However, its benefits for patients suffering from chronic obstructive pulmonary disease (COPD) are unclear. This study aims to assess the efficacy, safety, and underlying mechanisms of Baduanjin exercise in patients with moderate-to-severe COPD (BROCADE) by remote monitoring.MethodsThis study protocol describes a multicenter, open-label, prospective randomized computed tomography. A total of 150 individuals who meet the inclusion criteria after the screening and consent processes will take part in the study. All participants will be provided routine medication and lifestyle interventions. They will be randomly assigned to a control group, a classical pulmonary rehabilitation group, or a Baduanjin group, which will undergo remotely monitored Baduanjin exercises for a cumulative duration of 1 hour per day, three times per week for 12 weeks. The participants will be followed for 24 weeks. The primary outcomes will be a 6-minutes walking distance and St. George's Respiratory Questionnaire index. The secondary outcomes will be lung function, cross-sectional area of the pectoralis major and subcutaneous fat, modified Medical Research Council score, COPD assessment test questionnaire results, extremity muscle strength, and quality of life. Any adverse events that may occur will be monitored and recorded.ResultsThis study is ongoing and will be submitted to a peer-reviewed journal for publication once completed.ConclusionA novel neutrophil-related inflammatory mechanism will potentially be identified. In addition, the study results will provide a safe, effective, simple and operational Baduanjin exercise protocol for moderate-to-severe COPD patients aimed at improving prognosis and quality of life.
| S-EPMC9803505 | biostudies-literature
Project description:Physical inactivity has emerged as an important cardiometabolic risk factor; however, the beneficial impacts of physical exercise according physical fitness status are still unclear. To analyze the lipoproteins and immune-endocrine response to acute aerobic exercise sessions performed at different intensities according physical fitness status and evaluated the gene expression in monocyte cells. Twelve individuals, divided into Low and High VO2max, performed three randomized acute exercise sessions at low (<60% VO2max), moderate (60-75% VO2max), and high (>90% VO2max) intensities. Blood samples were collected pre, immediately post, and 60?minutes post-exercise to analyze NEFA, triacylglycerol, non-HDL-c, HDL-c, PAI-1, leptin and adiponectin concentrations. Blood samples were collected from another set of twelve individuals for use in monocyte cell cultures to analyze L-CAT, CETP, and AMPK gene expressions. Low VO2max group pre-exercise exhibited higher postprandial leptin and total cholesterol concentrations than High VO2max group (p?<?0.05). Exercise performed in high-intensity promoted a decreased leptin and NEFA levels (p?<?0.05, for both), but for PAI-1 levels was decreased (p?<?0.05) only for the Low VO2max group. Triacylglycerol levels decreased after all exercise sessions (p?<?0.05) for both groups, and HDL-c exhibited decrease during moderate-intensity (p?<?0.05), but this scenario was attenuated in Low VO2max group. Low VO2max individuals exhibit some metabolic-endocrine disruption, and acute aerobic exercise sessions performed at low, moderate, and high intensities are capable of modulating metabolic-endocrine parameters, mainly at high-intensity, in a physical fitness-dependent way, given that Low VO2max group was more responsive and seem to be able to appropriate more exercise-related benefits.
| S-EPMC7058045 | biostudies-literature
Project description:Aerobic exercise (AEx) exerts antidepressant effects, although the neurobiological mechanisms underlying such effects are not well understood. Reduced brain-derived neurotrophic factor (BDNF) and elevated cortisol have been implicated in the pathophysiology of depression and appear to normalize with antidepressant treatment. Thus, BDNF and cortisol may serve as biological targets for developing AEx as an antidepressant treatment. PURPOSE:This study examined the effects of AEx, of different intensities, on serum BDNF and cortisol in individuals with and without depression. METHODS:Thirteen participants with depression (10 females; age = 27.2 ± 6.9 yr; Montgomery-Äsberg Depression Rating Scale = 21.7 ± 4.7) and 13 control participants (10 females; age 27.2 ± 7.2 yr; Montgomery-Äsberg Depression Rating Scale = 0.5 ± 0.9) participated. Experimental visits consisted of 15 min of low-intensity cycling (LO) at 35% heart rate reserve, high-intensity cycling (HI) at 70% heart rate reserve, or sitting (CON). During each visit, blood samples were obtained at baseline, immediately postexercise (IP), and then every 15 min postexercise for 1 h (15P, 30P, 45P, and 60P). Group, condition, and time differences in BDNF and cortisol were assessed. RESULTS:There were no group differences in cortisol and BDNF. Secondary analysis revealed that BDNF increased in an intensity-dependent nature at IP, and cortisol was significantly elevated at 15P after HI. Changes in BDNF and cortisol showed significant linear relationships with changes in HR. CONCLUSION:HI AEx can elicit acute, transient increases in BDNF and cortisol in young, healthy, and physically active, nondepressed and mild to moderately depressed individuals. This work suggests that AEx has potential to significantly affect the central nervous system function, and the magnitude of such effect may be directly driven by exercise intensity.
| S-EPMC6629513 | biostudies-literature
Project description:BackgroundExercise is an effective adjuvant therapy that can alleviate treatment-related toxicities for men with prostate cancer (PC). However, the feasibility of delivering exercise training to men with advanced disease and the wider impact on clinical outcomes remain unknown. The purpose of the EXACT trial was to determine the feasibility and effects of home-based exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC).MethodsPatients with mCRPC receiving ADT + an androgen receptor pathway inhibitor (ARPI) were prescribed 12 weeks of home-based, remotely monitored, moderate intensity, aerobic and resistance exercise. Feasibility was assessed using recruitment, retention and adherence rates. Safety and adverse events were monitored throughout, with functional and patient-reported outcomes captured at baseline, post-intervention and at 3-month follow-up.ResultsFrom the 117 screened, 49 were deemed eligible and approached, with 30 patients providing informed consent (61% recruitment rate). Of those who consented, 28 patients completed baseline assessments, with 24 patients completing the intervention and 22 completing follow-up (retention rates: 86% and 79% respectively). Task completion was excellent throughout, with no intervention-related adverse events recorded. Self-reported adherence to the overall intervention was 82%. Exercise training decreased mean body mass (-1.5%), improved functional fitness (> 10%) and improved several patient-reported outcomes including clinically meaningful changes in fatigue (p = 0.042), FACT-G (p = 0.054) and FACT-P (p = 0.083), all with moderate effect sizes.ConclusionHome-based exercise training, with weekly remote monitoring, was feasible and safe for men with mCRPC being treated with an ARPI. Given that treatment-related toxicities accumulate throughout the course of treatment, and as a result, negatively impact functional fitness and health-related quality of life (HRQoL), it was positive that exercise training improved or prevented a decline in these clinically important variables and could better equip patients for future treatment. Collectively, these preliminary feasibility findings support the need for a definitive, larger RCT, which downstream may lead to the inclusion of home-based exercise training as part of adjuvant care for mCRPC.
| S-EPMC10319656 | biostudies-literature
Project description:IntroductionGestational weight gain (GWG) and postpartum weight retention (PPWR) are significant, potentially modifiable, contributors to women's future weight and health trajectories. There is a need for feasible and patient-centered (i.e., convenient, remotely-delivered, technology-enhanced, and accessible through the prenatal care setting) behavioural interventions that limit GWG and PPWR. This study tests the feasibility and acceptability of a remotely-delivered behavioural health coaching intervention to limit gestational weight gain and postpartum weight retention.MethodsPregnant women (11-16 weeks gestation) were recruited from two prenatal clinics and randomized to the active intervention or health education comparison group. Completion of the program was monitored and perceived helpfulness was rated (0-100).ResultsTwenty-six women were randomized (n = 13 per arm; mean age = 31.6 years, SD = 3.6; mean BMI = 26.7 kg/m2, SD = 7.4). Participants completed a median of 18 coaching calls and 16/19 learning activities during pregnancy, and a median of 6 calls and 5/6 learning activities postpartum. They logged weights at least once/week for a median of 36/38 expected weeks and tracked daily calories and exercise for a median of 154/266 days and 72/266 days, respectively. Median (Q1, Q3) helpfulness ratings of the program during pregnancy were 80 (64, 91) and 62 (50, 81) postpartum; helpfulness ratings of coaching calls were 85 (58, 98). At 37 weeks gestation, 77% of participants achieved IOM weight gain recommendations compared to 54% in the comparison group.ConclusionsThis study provides evidence for the feasibility and acceptability of a remotely-delivered behavioural weight control intervention in pregnancy and postpartum.
| S-EPMC7556432 | biostudies-literature
Project description:Sarcopenia, age-associated involuntary loss of muscle and strength, can progress to clinically relevant functional decline. Resistance exercise attenuates muscle and strength loss but may not be feasible for some older adults. Aerobic exercise training (AET) improves cardiopulmonary health; however, effects on protein turnover, muscle mass, and strength are less clear. We aimed to determine whether AET improves basal myofibrillar protein synthesis (MPS) and capillarization, promoting hypertrophy and strength. We hypothesized that AET improves strength with increased MPS and capillarization. Older adults were randomized to non-exercise (NON; n = 11, 71.4 ± 4.18 years) or exercise (EX; n = 12, 73.7 ± 4.05 years). EX completed 24 weeks of AET (walking 3×/week, 45 minutes, 70% heart rate reserve); NON remained sedentary. A stable isotope tracer was infused. MPS and capillarization were analyzed from vastus lateralis muscle biopsies. Strength was measured via isokinetic dynamometry. Lean mass was determined with dual-energy X-ray absorptiometry. Basal MPS increased in EX (+50.7%, P = 0.01) along with capillary density (+66.4%, P = 0.03), peak oxygen consumption (+15.8%, P = 0.01), quadriceps strength (+15.1%, P = 0.01), and muscle quality (peak torque divided by leg lean mass, +15.5%, P = 0.01). Lean mass did not change (P > 0.05). AET increases muscle protein turnover and capillarization in older adults, improving muscle quality.
| S-EPMC6518946 | biostudies-literature