Dataset Information

Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Anthracycline-based chemotherapy has been mainstay of adjuvant breast cancer therapy for decades. Although effective, anthracyclines place long-term breast cancer survivors at risk of late effects, such as reduced cardiorespiratory fitness and increased risk of cardiovascular disease. Previous research has shown beneficial effects of exercise training on cardiorespiratory fitness, but the effects of exercise on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes in long-term survivors are less clear. Whether previous exposure to breast cancer therapy modulates the effects of exercise is also unknown.

Objective

The primary aim of the CAUSE (Cardiovascular Survivors Exercise) trial is to examine the effect of aerobic exercise on cardiorespiratory fitness in anthracycline-treated long-term breast cancer survivors. Secondary aims are to examine effects of exercise training on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes, and to compare baseline values and effects of exercise training between similar-aged women with and those without prior breast cancer. A third aim is to examine the 24-month postintervention effects of aerobic exercise on primary and secondary outcomes.

Methods

The CAUSE trial is a 2-armed randomized controlled trial, where 140 long-term breast cancer survivors, 8-12 years post diagnosis, are assigned to a 5-month nonlinear aerobic exercise program with 3 weekly sessions or to standard care. Seventy similar-aged women with no history of cancer will undergo the same exercise program. Cardiorespiratory fitness measured as peak oxygen consumption (VO_2peak), limiting factors for VO_2peak (eg, cardiac function, pulmonary function, hemoglobin mass, blood volume, and skeletal muscle characteristics), cardiovascular risk factors (eg, hypertension, diabetes, dyslipidemia, obesity, physical activity level, and smoking status), and patient-reported outcomes (eg, body image, fatigue, mental health, and health-related quality of life) will be assessed at baseline, post intervention, and 24 months post intervention.

Results

A total of 209 patients were included from October 2020 to August 2022, and postintervention assessments were completed in January 2023. The 24-month follow-up will be completed in February 2025.

Conclusions

The findings from the CAUSE trial will provide novel scientific understanding of the potential benefits of exercise training in long-term breast cancer survivors.

Trial registration

ClinicalTrials.gov NCT04307407; https://clinicaltrials.gov/ct2/show/NCT04307407.

International registered report identifier (irrid)

DERR1-10.2196/45244.

SUBMITTER: Nilsen TS

PROVIDER: S-EPMC10131898 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial.

Nilsen Tormod Skogstad TS Sæter Mali M Sarvari Sebastian Imre SI Reinertsen Kristin Valborg KV Johansen Sara Hassing SH Edvardsen Elisabeth Rustad ER Hallén Jostein J Edvardsen Elisabeth E Grydeland May M Kiserud Cecilie Essholt CE Lie Hanne Cathrine HC Solberg Paul André PA Wisløff Torbjørn T Sharples Adam Philip AP Raastad Truls T Haugaa Kristina Hermann KH Thorsen Lene L

JMIR research protocols 20230315

<h4>Background</h4>Anthracycline-based chemotherapy has been mainstay of adjuvant breast cancer therapy for decades. Although effective, anthracyclines place long-term breast cancer survivors at risk of late effects, such as reduced cardiorespiratory fitness and increased risk of cardiovascular disease. Previous research has shown beneficial effects of exercise training on cardiorespiratory fitness, but the effects of exercise on limiting factors for cardiorespiratory fitness, cardiovascular ris ...[more]

PMID: 36920460

Similar Datasets

Project description:BackgroundCardiotoxicity from chemotherapy is a serious risk to the quality of survival of breast cancer survivors (BCS), and aerobic combined with resistance exercise (CE) has the potential to combat this cardiac damage. However, there is a lack of high-quality studies to assess the specific effects of CE. This study aimed to investigate the effects of CE on cardiopulmonary function (CRF) and cardiometabolic health in BCS.MethodsA comprehensively searched of the 4 databases (PubMed, Embase, Web of Science, Cochrane Library) from the database construction until March 1, 2023. The included studies were randomized controlled trials (RCTs) reporting the effects of CE on CRF and cardiometabolic health in BCS. The quality of the literature was assessed by two independent reviewers using the Cochrane Collaboration Risk of Bias Tool. Weight means difference (WMD), or standardized mean difference (SMD), were combined using random or fixed effects models. Subgroup and meta-regression explored heterogeneity as well as covariate effects.Results40 studies were included in the meta-analysis, with 2849 participants. Results showed that CE significantly increased maximal oxygen uptake (VO2max) (WMD:4.55; 95% CI:2.84, 6.26; I2 = 91.90%, P < 0.001) and reduced body weight (BW) (WMD: 1.61; 95% CI: 2.44, -0.78; I2 = 38.60%, P = 0.032) and body mass index (BMI) (WMD: 0.86; 95% CI: 1.43, -0.29; I2 = 70.50%, P < 0.001) in BCS. Subgroup analysis showed that BMI (WMD: 1.15; 95% CI: 1.89, -0.41; I2 = 76.90%, P < 0.001) and VO2max (WMD:4.21; 95% CI:2.40, 6.02; I2 = 96.4%, P < 0.001) were more effective with supervision. Meta-regression analysis showed that sample size had a significant moderating effect on BW (Coeff: 0.03, 95% CI: 0.00, 0.06).ConclusionsCE significantly increases CRF in BCS and improves most cardiometabolic health-related outcomes. In addition, there will be a need for many larger RCTs to explore the effects of CE on inflammatory biomarkers in BCS.

Project description:ImportanceAdverse cardiovascular findings associated with habitual vigorous exercise have raised new questions regarding the benefits of exercise and fitness.ObjectiveTo assess the association of all-cause mortality and cardiorespiratory fitness in patients undergoing exercise treadmill testing.Design, setting, and participantsThis retrospective cohort study enrolled patients at a tertiary care academic medical center from January 1, 1991, to December 31, 2014, with a median follow-up of 8.4 years. Data analysis was performed from April 19 to July 17, 2018. Consecutive adult patients referred for symptom-limited exercise treadmill testing were stratified by age- and sex-matched cardiorespiratory fitness into performance groups: low (<25th percentile), below average (25th-49th percentile), above average (50th-74th percentile), high (75th-97.6th percentile), and elite (≥97.7th percentile).ExposuresCardiorespiratory fitness, as quantified by peak estimated metabolic equivalents on treadmill testing.Main outcomes and measuresAll-cause mortality.ResultsThe study population included 122 007 patients (mean [SD] age, 53.4 [12.6] years; 72 173 [59.2%] male). Death occurred in 13 637 patients during 1.1 million person-years of observation. Risk-adjusted all-cause mortality was inversely proportional to cardiorespiratory fitness and was lowest in elite performers (elite vs low: adjusted hazard ratio [HR], 0.20; 95% CI, 0.16-0.24; P < .001; elite vs high: adjusted HR, 0.77; 95% CI, 0.63-0.95; P = .02). The increase in all-cause mortality associated with reduced cardiorespiratory fitness (low vs elite: adjusted HR, 5.04; 95% CI, 4.10-6.20; P < .001; below average vs above average: adjusted HR, 1.41; 95% CI, 1.34-1.49; P < .001) was comparable to or greater than traditional clinical risk factors (coronary artery disease: adjusted HR, 1.29; 95% CI, 1.24-1.35; P < .001; smoking: adjusted HR, 1.41; 95% CI, 1.36-1.46; P < .001; diabetes: adjusted HR, 1.40; 95% CI, 1.34-1.46; P < .001). In subgroup analysis, the benefit of elite over high performance was present in patients 70 years or older (adjusted HR, 0.71; 95% CI, 0.52-0.98; P = .04) and patients with hypertension (adjusted HR, 0.70; 95% CI, 0.50-0.99; P = .05). Extreme cardiorespiratory fitness (≥2 SDs above the mean for age and sex) was associated with the lowest risk-adjusted all-cause mortality compared with all other performance groups.Conclusions and relevanceCardiorespiratory fitness is inversely associated with long-term mortality with no observed upper limit of benefit. Extremely high aerobic fitness was associated with the greatest survival and was associated with benefit in older patients and those with hypertension. Cardiorespiratory fitness is a modifiable indicator of long-term mortality, and health care professionals should encourage patients to achieve and maintain high levels of fitness.

Dataset Information

Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets