Exercise Preferences, Barriers, and Facilitators of Individuals With Cancer Undergoing Chemotherapy Before Stem Cell Transplantation: A Mixed-Methods Study.

BACKGROUND: Exercise can help mitigate side effects of hematopoietic stem cell transplantation (HSCT), particularly when initiated before HSCT. However, the exercise-related barriers, facilitators, and preferences of this population remain unclear. OBJECTIVE: This study aimed to explore the patient experience to inform future implementation of a prehabilitation intervention. INTERVENTIONS/METHODS: A 2-phase sequential explanatory mixed-methods study was conducted using (1) cross-sectional survey and (2) focus groups. Survey questions aligned with the Theoretical Domains Framework. Focus group data were analyzed using a directed content analysis approach, followed by inductive thematic analysis to generate themes that represented the exercise-related barriers, facilitators, and preferences of participants. RESULTS: Twenty-six participants completed phase 1 (n = 22 with multiple myeloma). Fifty percent of participants (n = 13) were fairly/very confident in their ability to exercise pre-HSCT. Eleven participants completed phase 2. Exercise barriers included knowledge/skill limitations, inadequate healthcare provider support, and the emotional toll of treatment. Facilitators included social support and goals. Exercise preferences were related to 2 themes: (1) program structure (subthemes: prescription and scheduling, mode of delivery) and (2) support (subthemes: support from personnel, tailoring, and education). CONCLUSION: Key exercise-related barriers included knowledge limitations, disease/treatment effects, and inadequate support. Prehabilitation should be tailored, flexible, and include education and a virtual or hybrid delivery model in this population. IMPLICATIONS FOR PRACTICE: Nurses are well positioned to identify functional limitations and counsel and refer patients to exercise programming and/or physiotherapy services. Including an exercise professional in the pretransplant care team would provide key supportive care assistance for the nursing team.

Virtual or In-Person: A Mixed Methods Survey to Determine Exercise Programming Preferences during COVID-19.

A survey was conducted to identify barriers and facilitators to engaging in virtual and in-person cancer-specific exercise during COVID-19. A theory-informed, multi-method, cross-sectional survey was electronically distributed to 192 individuals with cancer investigating preferences towards exercise programming during COVID-19. Respondents had previously participated in an exercise program and comprised two groups: those who had experience with virtual exercise programming ('Virtual') and those who had only taken part in in-person exercise ('In-Person'). Quantitative data were summarized descriptively. Qualitative data were thematically categorized using framework analysis and findings were mapped to an implementation model. The survey completion response rate was 66% (N = 127). All respondents identified barriers to attending in-person exercise programming during COVID-19 with concerns over the increased risk of viral exposure. Virtual respondents (n = 39) reported: (1) feeling confident in engaging in virtual exercise; and (2) enhanced motivation, accessibility and effectiveness as facilitators to virtual exercise. In-Person respondents (n = 88) identified: (1) technology as a barrier to virtual exercise; and (2) low motivation, accessibility and exercise effectiveness as barriers towards virtual exercise. Sixty-six percent (n = 58) of In-Person respondents reported that technology support would increase their willingness to exercise virtually. With appropriately targeted support, perceived barriers to accessing virtual exercise-including motivation, accessibility and effectiveness-may become facilitators. The availability of technology support may increase the engagement of individuals with cancer towards virtual exercise programming.

Feasibility of Implementing Cancer-Specific Community-Based Exercise Programming: A Multi-Centre Randomized Trial.

BACKGROUND: There is growing recognition of the importance of reporting preliminary work on the feasibility of a trial. The present study aimed to assess the feasibility of (1) a proposed fitness testing battery, and (2) processes related to the implementation of cancer-specific exercise programming in a community setting. METHODS/DESIGN: A randomized controlled implementation feasibility trial was performed in advance of a large-scale implementation study. Eligible participants within 18 months of a cancer diagnosis were randomized to immediate or delayed community-based exercise at YMCA locations in Calgary and Edmonton, Canada for an 8-week period. The primary outcome for the trial was the feasibility of the physical fitness testing battery, defined as a 70% or greater completion rate across the 24-week study period. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was used to evaluate processes related to implementation of the exercise program across the two sites. RESULTS: Eighty participants were recruited, 73 (91%) completed the 8-week trial, and 68 (85%) completed the 16- and 24-week follow-ups. Sixty participants (75%) completed the full physical fitness test battery at each time point, and 59 (74%) completed the patient-reported outcome measures. Statistically significant between-group differences were found in favor of the exercise group for functional aerobic capacity, upper and lower extremity strength, and symptoms. Differences were found between the sites, however, in completion rates and processes related to program implementation. DISCUSSION: Findings suggest the need for minor adaptations to the physical fitness battery and outcome measures to better fit the community context. While findings support feasibility, context-specific challenges related to implementation processes were identified.

A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study.

BACKGROUND: Our aim was to understand cancer survivor needs prior to, and following the Alberta Cancer Exercise (ACE) pilot randomized trial as a means to inform implementation of a province-wide cancer-specific, community-based exercise program. METHODS: Questionnaires and semi-structured stakeholder engagement sessions were conducted with cancer survivors to explore preferences, barriers and facilitators/benefits at two timepoints: (1) pre-ACE: prior to initiation of the ACE pilot trial (n = 13 survivors and n = 5 caregivers); and (2) post-ACE: following participation in the ACE pilot trial (n = 20 survivors). Descriptive statistics were used to summarize quantitative data from questionnaires. Stakeholder engagement data were analyzed using a framework analysis approach. Emergent themes were then mapped to actionable outcomes. RESULTS: Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible. Post-ACE, participants identified (1) a lack of exercise counseling from health care providers, (2) the need for earlier introduction of exercise in the care pathway, and (3) supported referral to exercise programming. CONCLUSIONS: An integrated knowledge translation approach identified actionable outcomes to address survivor needs related to exercise in clinical cancer and community-based contexts.

Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study.

INTRODUCTION: Cancer care has expanded from a disease-focused, survival-oriented model to an approach that now considers how survivors can live well in the aftermath of intensive therapy, where they may deal with significant changes to their bodies, mental health or emotional well-being. Research evidence supports the benefit of exercise during and following cancer treatments for cancer-related symptoms, physical functioning and fitness, and health-related quality of life. To move this efficacy evidence into practice, we designed and launched a 5-year study to evaluate the relative benefit from implementing a clinic-to-community-based cancer and exercise model of care. METHODS AND ANALYSIS: A hybrid effectiveness and implementation trial design is being used to evaluate the effectiveness of delivery of community-based exercise and to collect data on implementation of the programme. The study opened in January 2017, with estimated completion by January 2022. The programme will be delivered in seven cities across the province of Alberta, Canada, with sites including three academic institutions, six YMCA locations, Wellspring Edmonton and Calgary, and six municipal fitness centres. Participants are adult cancer survivors (n=2500) from all tumour groups and stages and at any time point along their cancer treatment trajectory, up to 3 years post treatment completion. Survivors take part in a minimum of 60 min of mild-to-moderate intensity full body exercise twice weekly for a 12-week period. The primary effectiveness outcome is the proportion of participants meeting or exceeding 150 min of moderate intensity exercise per week at 1-year follow-up. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be utilised to capture individual-level and organizational-level impact of the exercise programme at 12 and 24 weeks and 1-year follow-up. The cohort of survivors participating in the study will allow for long-term (>5-year) evaluation of rates of cancer recurrence and secondary cancers beyond the funding period. ETHICS AND DISSEMINATION: The study was approved by the Health Research Ethics Board of Alberta. The study is funded by Alberta Innovates and the Alberta Cancer Foundation. The study will help to answer critical questions on the effectiveness of cancer-specific community-based exercise programming in both the short-term and the long-term. Collectively, the findings will help to inform the acceptability, adoption, feasibility, reach and sustainability of community-based exercise. TRIAL REGISTRATION NUMBER: NCT02984163; Pre-results.

Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors.

Exercise training improves health-related physical fitness and patient-reported outcomes in cancer survivors, but few interventions have targeted colorectal cancer (CRC) survivors. This investigation aimed to determine the feasibility and efficacy of a 12-week supervised exercise training program for CRC survivors. Feasibility was assessed by tracking participant recruitment, loss to follow-up, assessment completion rates, participant evaluation, and adherence to the intervention. Efficacy was determined by changes in health-related physical fitness. Over a 1-year period, 72 of 351 (21%) CRC survivors screened were eligible for the study and 29 of the 72 (40%) were enrolled. Two participants were lost to follow-up (7%) and the completion rate for all study assessments was ≥93%. Mean adherence to the exercise intervention was 91% (standard deviation = ±18%), with a median of 98%. Participants rated the intervention positively (all items ≥ 6.6/7) and burden of testing low (all tests ≤ 2.4/7). Compared with baseline, CRC survivors showed improvements in peak oxygen uptake (mean change (MC) = +0.24 L·min(-1), p < 0.001), upper (MC = +7.0 kg, p < 0.001) and lower (MC = +26.5 kg, p < 0.001) body strength, waist circumference (MC = -2.1 cm, p = 0.005), sum of skinfolds (MC = -7.9 mm, p = 0.006), and trunk forward flexion (MC = +2.5 cm, p = 0.019). Exercise training was found to be feasible and improved many aspects of health-related physical fitness in CRC survivors that may be associated with improved quality of life and survival in these individuals.

Patient satisfaction with participation in a randomized exercise trial: effects of randomization and a usual care posttrial exercise program.

BACKGROUND: Participation in an exercise trial is a major commitment for cancer survivors, but few exercise trials have evaluated patient satisfaction with trial participation. PURPOSE: To examine patient satisfaction with participation in the Healthy Exercise for Lymphoma Patients (HELP) Trial and to explore possible determinants. METHODS: The HELP Trial randomized 122 lymphoma patients to 12 weeks of supervised aerobic exercise training (AET; n = 60) or to usual care (UC; n = 62), with the option of participating in a 4-week posttrial exercise program. At the 6-month follow-up assessment, participants evaluated their overall trial satisfaction. RESULTS: Personal satisfaction with trial participation was strongly influenced by group assignment with participants randomized to AET reporting participation to be more rewarding (p < 0.001) and personally useful (p < 0.001) than participants randomized to UC. UC participants who completed the optional 4-week posttrial exercise program reported participation to be more rewarding (p = 0.008) and personally useful (p < 0.001) than UC participants who declined the program. LIMITATIONS: The study is limited by the lack of a validated measure of participant satisfaction, and the fact that the offer of participation in the posttrial exercise program to the UC group was not randomized. CONCLUSIONS: Lymphoma patients randomized to UC viewed it as less rewarding and personally useful despite being offered a 4-week posttrial exercise program. UC participants who completed the 4-week program reported personal satisfaction levels similar to the AET group; however, the causal direction of this association is unknown. Researchers should continue to evaluate participant satisfaction in exercise trials.

A randomized trial of aerobic exercise and sleep quality in lymphoma patients receiving chemotherapy or no treatments.

BACKGROUND: Patients with lymphoma experience sleep problems that may be managed with aerobic exercise but no previous study has examined this issue. METHODS: We randomized 122 patients with lymphoma to usual care (n = 62) or 12 weeks of supervised aerobic exercise training (AET; n = 60). Our primary sleep endpoint was global sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI). Secondary endpoints were the PSQI component scores. Planned subgroup analyses were also conducted. RESULTS: Intention-to-treat analyses indicated that AET resulted in a nonsignificant (P = 0.16) improvement in global sleep quality compared with usual care [mean group difference = -0.64; 95% confidence interval (CI), -1.56 to +0.27]. In planned subgroup analyses, statistically significant or borderline significant interactions were identified for type of lymphoma (P(interaction) = 0.006), current treatment status (P(interaction) = 0.036), time since diagnosis (P(interaction) = 0.010), body mass index (P(interaction) = 0.075), and baseline sleep quality (P(interaction) = 0.041). Specifically, AET improved global sleep quality in patients with lymphoma who had indolent non-Hodgkin lymphoma (P = 0.001), were receiving chemotherapy (P = 0.013), were <2 years post-diagnosis (P = 0.005), were obese (P = 0.025), and were poor sleepers at baseline (P = 0.007). CONCLUSIONS: AET did not significantly improve sleep quality in this heterogeneous sample of patients with lymphoma; however, clinically identifiable subgroups appeared to benefit. Future exercise trials targeting these responsive subgroups are needed to confirm these findings. IMPACT: If replicated in larger and more focused trials, aerobic exercise may be an attractive option to manage sleep dysfunction in patients with cancer because of its favorable safety profile and other documented health benefits.

Predictors of follow-up exercise behavior 6 months after a randomized trial of supervised exercise training in lymphoma patients.

OBJECTIVES: Supervised exercise is beneficial for lymphoma patients, but it needs to be maintained to optimize long-term benefits. Here, we report the predictors of follow-up exercise behavior 6 months after a randomized controlled trial in lymphoma patients. METHODS: Lymphoma patients were randomly assigned to 12 weeks of supervised aerobic exercise (n = 60) or usual care (n = 62). At baseline and post-intervention, data were collected on demographic, medical, health-related fitness, quality of life, and motivational variables. At 6-month follow-up, participants were mailed a questionnaire that assessed exercise behavior and were categorized as meeting or not meeting public health exercise guidelines. RESULTS: At 6-month follow-up, 110 participants (90.2%) responded, of which 61 (55.5%) were meeting public health exercise guidelines. In univariate analyses, 16 variables predicted 6-month follow-up exercise behavior. In a stepwise regression analysis, five variables entered the model and explained 38% (p < 0.001) of the variance including the following: accepting a post-intervention exercise prescription (ß = 0.33; p < 0.001), achieving a higher peak power output at post-intervention (ß = 0.28; p = 0.001), experiencing a larger positive change in perceived behavioral control (ß = 0.18; p = 0.028), having Hodgkin lymphoma (ß = 0.19; p = 0.025), and having a stronger post-intervention intention (ß = 0.18; p = 0.034). CONCLUSION: Exercise behavior in lymphoma patients 6 months after a randomized trial was predicted by a wide range of demographic, medical, health-related fitness, quality of life, and motivational variables. These findings may help facilitate the uptake of self-directed exercise after short-term supervised exercise in lymphoma patients.

Effects of supervised exercise on motivational outcomes and longer-term behavior.

INTRODUCTION: Supervised exercise may have positive effects on motivation and continued exercise in cancer survivors, but few randomized controlled trials have examined this issue. Here, we report the motivational outcomes and longer-term exercise behavior from the Healthy Exercise for Lymphoma Patients trial. METHODS: Lymphoma patients were randomly assigned to 12 wk of supervised aerobic exercise (SUP, n = 60) or usual care (UC, n = 62). Motivational outcomes from the theory of planned behavior were assessed at baseline, after intervention, and at 6-month follow-up using standardized measures. Exercise behavior was self-reported at baseline and 6-month follow-up using the Godin Leisure Time Exercise Questionnaire. RESULTS: Data were available from 95% of participants after intervention and 90% at 6-month follow-up. SUP attended a median of 92% of the supervised exercise sessions. After intervention, SUP was superior to UC for intention (+0.41 (+0.09 to +0.72), P = 0.012) and perceived behavioral control (+0.36 (+0.01 to +0.72), P = 0.047) and borderline superior for self-efficacy (+0.35 (-0.02 to +0.72), P = 0.060). At 6-month follow-up, SUP reported significantly more exercise minutes compared with UC (+133 (+38 to +227), P = 0.006), and a higher percentage of SUP participants were meeting public health exercise guidelines (+25.6% (+8.2% to +43.0%), P = 0.004). Path analysis showed that perceived behavioral control partially mediated the effects of supervised exercise (group assignment) on exercise behavior at 6-month follow-up (meeting exercise guidelines). CONCLUSIONS: Supervised exercise has motivational effects in lymphoma patients and improves longer-term exercise behavior. Strategies to further enhance the motivational value of supervised exercise are warranted.

Physical activity and gastrointestinal cancer survivorship.

Research examining physical activity in gastrointestinal cancer survivors is in its early stages and has focused primarily on colorectal cancer. Moreover, the majority of the research to date has been observational in nature, with very little interventional research. Though limited, the results of this research have been promising in nature, showing positive associations between physical activity and quality of life as well as disease outcomes, including improved disease-free and overall survival. The potential benefits of physical activity for gastrointestinal cancer survivors warrant further research on the underlying mechanisms of the relationship between physical activity and colorectal cancer disease outcomes, to determine if these associations extend to other gastrointestinal cancers, and to determine appropriate physical activity interventions to realize any potential supportive care benefits in various gastrointestinal cancer survivor groups.

Predictors of adherence to supervised exercise in lymphoma patients participating in a randomized controlled trial.

Exercise improves health in lymphoma patients but the determinants of adherence in this population are unknown. The purpose of this study is to examine predictors of exercise adherence in lymphoma patients. In a randomized trial, 60 lymphoma patients were assigned to the exercise group and asked to attend three supervised exercise sessions per week for 12 weeks. Baseline data were collected on demographic, medical, fitness, psychosocial, and motivational variables. Adherence was assessed by objective attendance. Adherence was 77.8% and was significantly predicted by age (beta = 0.29; p = 0.016) and past exercise (beta = 0.27; p = 0.024); and borderline significantly predicted by previous treatments (beta = 0.22; p = 0.053), body mass index (beta = -0.21; p = 0.076), and smoking (beta = -0.19; p = 0.092). Poorer exercise adherence was experienced by lymphoma patients under age 40, insufficiently active at baseline, previously treated with radiation therapy, overweight or obese, and smokers. Findings may facilitate the development of targeted interventions to improve exercise adherence in this understudied patient population.

Moderator effects in a randomized controlled trial of exercise training in lymphoma patients.

BACKGROUND: The Healthy Exercise for Lymphoma Patients trial showed that aerobic exercise training improved important health outcomes in lymphoma patients. Here, we examine potential moderators of the exercise training response. METHODS: Lymphoma patients were stratified by major disease type and current treatment status and randomly assigned to usual care (n = 62) or aerobic exercise training (n = 60) for 12 weeks. Endpoints were quality of life, cardiovascular fitness, and body composition. Moderators were patient preference for group assignment, age, sex, marital status, disease stage, body mass index, and general health. RESULTS: Patient preference did not statistically moderate the effects of exercise training on quality of life (P for interaction = 0.36), but the interaction effect of 7.8 points favoring patients with no preference was clinically meaningful. Marital status (P for interaction = 0.083), general health (P for interaction = 0.012), and body mass index (P for interaction = 0.010) moderated the effects of aerobic exercise training on quality of life with better outcomes for unmarried versus married patients, patients in poor/fair health versus good-to-excellent health, and normal weight/obese versus overweight patients. Disease stage (P for interaction = 0.056) and general health (P for interaction = 0.012) moderated the effects of aerobic exercise training on body composition with better outcomes for patients with advanced disease versus early disease/no disease and patients in good health versus very good-to-excellent health. No variables moderated intervention effects on cardiovascular fitness. Findings were not explained by differences in adherence. CONCLUSIONS: Clinically available variables predicted quality of life and body composition responses to aerobic exercise training in lymphoma patients. If replicated, these results may inform future randomized trials and clinical practice.

Randomized controlled trial of the effects of aerobic exercise on physical functioning and quality of life in lymphoma patients.

PURPOSE: Lymphoma patients commonly experience declines in physical functioning and quality of life (QoL) that may be reversed with exercise training. PATIENTS AND METHODS: We conducted a randomized controlled trial in Edmonton, Alberta, Canada, between 2005 and 2008 that stratified 122 lymphoma patients by major disease type and current treatment status and randomly assigned them to usual care (UC; n = 62) or 12 weeks of supervised aerobic exercise training (AET; n = 60). Our primary end point was patient-rated physical functioning assessed by the Trial Outcome Index-Anemia. Secondary end points were overall QoL, psychosocial functioning, cardiovascular fitness, and body composition. RESULTS: Follow-up assessment for our primary end point was 96% (117 of 122) at postintervention and 90% (110 of 122) at 6-month follow-up. Median adherence to the supervised exercise program was 92%. At postintervention, AET was superior to UC for patient-rated physical functioning (mean group difference, +9.0; 95% CI, 2.0 to 16.0; P = .012), overall QoL (P = .021), fatigue (P = .013), happiness (P = .004), depression (P = .005), general health (P < .001), cardiovascular fitness (P < .001), and lean body mass (P = .008). Change in peak cardiovascular fitness mediated the change in patient-rated physical functioning. AET did not interfere with chemotherapy completion rate or treatment response. At 6-month follow-up, AET was still borderline or significantly superior to UC for overall QoL (P = .054), happiness (P = .034), and depression (P = .009) without an increased risk of disease recurrence/progression. CONCLUSION: AET significantly improved important patient-rated outcomes and objective physical functioning in lymphoma patients without interfering with medical treatments or response. Exercise training to improve cardiovascular fitness should be considered in the management of lymphoma patients.

Correlates of adherence to supervised exercise in patients awaiting surgical removal of malignant lung lesions: results of a pilot study.

PURPOSE/OBJECTIVES: To examine the demographic, medical, and social-cognitive correlates of adherence to a presurgical exercise training intervention in patients awaiting surgery for suspected malignant lung lesions. DESIGN: Pilot study, single-group, prospective design with convenience sampling. SETTING: Exercise training was performed at a university research fitness center in western Canada. SAMPLE: 19 patients awaiting surgical resection of suspected malignant lung lesions. METHODS: At baseline, participants completed a questionnaire including the Theory of Planned Behavior variables of perceived behavioral control, attitude, and subjective norm, as well as medical and demographic information. Participants were asked to attend five supervised exercise sessions per week during surgical wait time (X = 8 +/- 2.4 weeks). MAIN RESEARCH VARIABLES: Theory of Planned Behavior variables and exercise adherence. FINDINGS: Adherence to the exercise intervention was 73% (range = 0%-100%). Correlates of adherence were perceived behavioral control (r = 0.63; p = 0.004) and subjective norm (r = 0.51; p = 0.014). Participants with greater than 80% adherence reported significantly higher behavioral control than participants with less than 80% adherence (X difference = 1.1; 95% confidence interval = 0.1-2.2; p = 0.035). Men had better adherence than women (X difference = 24.9%; 95% confidence interval = 0.4-49.4; p = 0.047). CONCLUSIONS: Perceived behavioral control and subjective norm were the strongest correlates of exercise adherence. Women could be at risk for poor exercise adherence prior to lung surgery. IMPLICATIONS FOR NURSING: This information could be useful for clinicians in their attempts to improve adherence to exercise interventions in patients awaiting surgery for malignant lung lesions.

Effects of presurgical exercise training on quality of life in patients undergoing lung resection for suspected malignancy: a pilot study.

The aim of this study was to explore the effects of presurgical exercise training on quality of life (QOL) in patients with malignant lung lesions. Using a single-group prospective design, patients were enrolled in supervised aerobic exercise training for the duration of surgical wait time (mean 59.7 days). Participants completed assessments of cardiorespiratory fitness (peak oxygen consumption) and QOL using the Functional Assessment of Cancer Therapy-Lung scales, including the trial outcome index (TOI) and the lung cancer subscale (LCS) at baseline, immediately presurgery, and postsurgery (mean, 57 days). 9 participants provided complete data. Repeated-measures analysis indicated a significant effect for time on TOI (P = .006) and LCS (P = .009). Paired analysis revealed that QOL was unchanged after exercise training (ie, baseline to presurgery), but there were significant and clinically meaningful declines from presurgery to postsurgery in the LCS (-3.6, P = .021) and TOI (-8.3, P = .018). Change in peak oxygen consumption from presurgery to postsurgery was significantly associated with change in the LCS (r = 0.70, P = .036) and TOI (r = 0.70, P = .035). Exercise training did not improve QOL from baseline to presurgery. Significant declines in QOL after surgery seem to be related to declines in cardiorespiratory fitness. A randomized controlled trial is needed to further investigate these relationships.

Effects of aerobic exercise training in anemic cancer patients receiving darbepoetin alfa: a randomized controlled trial.

BACKGROUND: Anemia in patients with solid tumors is a common problem that is associated with impaired exercise capacity, increased fatigue, and lower quality of life (QoL). Erythropoiesis-stimulating agents (ESAs) have been shown to improve these outcomes; however, it is unknown if additional benefits can be achieved with aerobic exercise training. METHODS: We conducted a single-center, prospective, randomized, controlled trial in 55 mild-to-moderately anemic patients with solid tumors. Patients were randomized to either darbepoetin alfa alone (DAL, n = 29) or darbepoetin alfa plus aerobic exercise training (DEX; n = 26). The DEX group performed aerobic exercise training three times per week at 60%-100% of baseline exercise capacity for 12 weeks. The primary endpoint was QoL assessed by the Functional Assessment of Cancer Therapy-Anemia scale. Secondary endpoints were fatigue, cardiorespiratory fitness (VO(2peak)), hemoglobin (Hb) response, and darbepoetin alfa dosing. RESULTS: Intention-to-treat analyses indicated significant improvements in QoL and fatigue in both groups over time but there were no between-group differences. The DEX group had a significantly greater VO(2peak) than the DAL group (mean group difference, +3.0 ml/kg per minute; 95% confidence interval, 1.2-4.7; p = .001) and there were borderline significant differences in favor of the DEX group for Hb response and darbepoetin alfa dosing. CONCLUSIONS: Aerobic exercise training did not improve QoL or fatigue beyond the established benefits of DAL but it did result in favorable improvements in exercise capacity and a more rapid Hb response with lower dosing requirements. Our results may be useful to clinicians despite the more recent restrictions on the indications for ESAs.