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A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Breast cancer patients have to face a high-risk state during chemotherapy, which involves deterioration of their health including extensive physical deterioration. Face-to-face physical exercise programs have presented low adherence rates during medical treatment, and telehealth systems could improve these adherence rates. OBJECTIVE:This study aimed to evaluate the effectiveness of a Web-based exercise program (e-CuidateChemo) to mitigate the side effects of chemotherapy on the physical being, anthropometric aspects, and body composition. METHODS:A total of 68 patients diagnosed with breast cancer, who were undergoing chemotherapy, were enrolled. The patients were categorized into two groups: e-CuidateChemo (n=34) and controls (n=34). The e-CuidateChemo group participated in an adapted 8-week tailored exercise program through a Web-based system. A blinded, trained researcher assessed functional capacity, strength, anthropometric parameters, and body composition. The intervention effects were tested using analysis of covariance and Cohen d tests. RESULTS:Functional capacity improved significantly in the e-CuidateChemo group compared to the control group (6-minute walk test: 62.07 [SD 130.09] m versus -26.34 [SD 82.21] m; 6-minute walk test % distance predicted: 10.81% [SD 22.69%] m versus -4.60% [SD 14.58%]; between-group effect: P=.015 for both). The intervention group also showed significantly improved secondary outcomes such as between-group effects for abdominal (24.93 [SD 26.83] s vs -18.59 [SD 38.69] s), back (12.45 [SD 10.20] kg vs 1.39 [10.72] kg), and lower body (-2.82 [SD 3.75] s vs 1.26 [SD 2.84] s) strength; all P<.001 compared to the control group. CONCLUSIONS:This paper showed that a Web-based exercise program was effective in reversing the detriment in functional capacity and strength due to chemotherapy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02350582; https://clinicaltrials.gov/ct2/show/NCT02350582.

SUBMITTER: Ariza-Garcia A

PROVIDER: S-EPMC6685131 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial.

Ariza-Garcia Angelica A Lozano-Lozano Mario M Galiano-Castillo Noelia N Postigo-Martin Paula P Arroyo-Morales Manuel M Cantarero-Villanueva Irene I

Journal of medical Internet research 20190724 7

<h4>Background</h4>Breast cancer patients have to face a high-risk state during chemotherapy, which involves deterioration of their health including extensive physical deterioration. Face-to-face physical exercise programs have presented low adherence rates during medical treatment, and telehealth systems could improve these adherence rates.<h4>Objective</h4>This study aimed to evaluate the effectiveness of a Web-based exercise program (e-CuidateChemo) to mitigate the side effects of chemotherap ...[more]

PMID: 31342907

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Project description:BackgroundDue to the high prevalence of depressive disorders, it is mandatory to develop therapeutic strategies that provide universal access and require limited financial and human resources. Web-based therapeutic approaches fulfill these conditions.ObjectiveThe objective of our study was to assess the feasibility, acceptability, and efficacy of a supervised, individualized 8-week Web-based exercise intervention conducted for patients with moderate to severe depression.MethodsWe recruited 20 patients with unipolar depression and randomly assigned them into 2 groups (intervention, exercise program group, n=14, and control, treatment-as-usual group, n=6). At baseline, depressive symptoms were rated via the Quick Inventory of Depressive Symptomatology (QIDS) by patients themselves (QIDS-self-report, QIDS-SR) and by a blinded psychiatrist (QIDS-clinician rating, QIDS-C). In addition, performance diagnostics (lactate analysis, spiroergometry during a treadmill walking test) were conducted. Quality of life was assessed via the Short Form-36 questionnaire (SF-36) and self-efficacy via the General Self-Efficacy scale (GSE). In addition, habitual physical activity (HPA) was determined via the Baecke questionnaire. Participants of the intervention group received exercise schedules once weekly with endurance and strength training instructions. Rating of depressive symptoms was repeated after 6-12 days and 8 weeks; performance diagnostics and the completion of all the questionnaires were repeated after 8 weeks only.ResultsThe severity of depression subsided significantly in the intervention group after 8 weeks (median change in QIDS-SR: -5; interquartile range, IQR: -2 to -10), although it was already evident within the first 6-12 days (median change in QIDS-SR: -6; IQR: -2 to -8). During the intervention, participants undertook a median of 75 (IQR: 63 to 98) minutes of endurance training per week or 84% (16 [IQR: 9 to 19] of 19 [IQR: 15 to 21]) recommended endurance units in total. In addition, 9 (IQR: 4 to 12) of 10 (IQR: 8 to 13) recommended strength training exercise units were conducted during the 8 weeks. Performance diagnostics revealed a substantial increase in the maximum output in Watt for the intervention group after 8 weeks. Moreover, the intervention showed a favorable effect on SF-36 items "emotional well-being" and "social functioning" as well as on GSE and HPA scores.ConclusionsOur individualized Web-based exercise intervention for moderate to severe depression was highly accepted by the patients and led to a significant and clinically relevant improvement of depressive symptoms.Trial registrationClinicalTrials.gov NCT02874833; https://clinicaltrials.gov/ct2/show/NCT02874833 (Archived by WebCite at http://www.webcitation.org/72ZUUR4tE).

Project description:PURPOSE:Over half of all cancer patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy experience chemotherapy-induced peripheral neuropathy (CIPN), which includes numbness, tingling, pain, cold sensitivity, and motor impairment in the hands and feet. CIPN is a dose-limiting toxicity, potentially increasing mortality. There are no FDA-approved drugs to treat CIPN, and behavioral interventions such as exercise are promising yet understudied. This secondary analysis of our nationwide phase III randomized controlled trial of exercise for fatigue examines (1) effects of exercise on CIPN symptoms, (2) factors that predict CIPN symptoms, and (3) factors that moderate effects of exercise on CIPN symptoms. METHODS:Cancer patients (N = 355, 56 ± 11 years, 93% female, 79% breast cancer) receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy were randomized to chemotherapy or chemotherapy plus Exercise for Cancer Patients (EXCAP©®). EXCAP is a standardized, individualized, moderate-intensity, home-based, six-week progressive walking and resistance exercise program. Patients reported CIPN symptoms of numbness and tingling and hot/coldness in hands/feet (0-10 scales) pre- and post-intervention. We explored baseline neuropathy, sex, age, body mass index, cancer stage, and cancer type as possible factors associated with CIPN symptoms and exercise effectiveness. RESULTS:Exercise reduced CIPN symptoms of hot/coldness in hands/feet (-0.46 units, p = 0.045) and numbness and tingling (- 0.42 units, p = 0.061) compared to the control. Exercise reduced CIPN symptoms more for patients who were older (p = 0.086), male (p = 0.028), or had breast cancer (p = 0.076). CONCLUSIONS:Exercise appears to reduce CIPN symptoms in patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy. Clinicians should consider prescribing exercise for these patients. TRIAL REGISTRATION:Clinical Trials.gov , # NCT00924651, http://www.clinicaltrials.gov .

Project description:BackgroundPatient preference for group assignment may affect outcomes in unblinded trials but few studies have attempted to understand such preferences. The purpose of the present study was to examine factors associated with breast cancer patients' preference for two types of exercise training during chemotherapy.MethodsBreast cancer patients (N = 242) completed a battery of tests including a questionnaire that assessed patient preference and the theory of planned behavior (TPB) prior to being randomized to usual care, resistance exercise training (RET), or aerobic exercise training (AET).Results99 (40.9%) participants preferred RET, 88 (36.4%) preferred AET, and 55 (22.7%) reported no preference. Past exercisers (p = 0.023), smokers (p = 0.004), and aerobically fitter participants (p = 0.005) were more likely to prefer RET. As hypothesized, participants that preferred AET had more favorable TPB beliefs about AET whereas participants that preferred RET had more favorable TPB beliefs about RET. In multivariate modeling, patient preference for RET versus AET was explained (R2 = .46; p < 0.001) by the difference in motivation for RET versus AET (beta = .56; p < 0.001), smoking status (beta = .13; p = 0.007), and aerobic fitness (beta = .12; p = 0.018). Motivational difference between RET versus AET, in turn, was explained (R2 = .48; p < 0.001) by differences in instrumental attitude (beta = .27; p < 0.001), affective attitude (beta = .25; p < 0.001), and perceived behavioral control (beta = .24; p < 0.001).ConclusionBreast cancer patients' preference for RET versus AET during chemotherapy was predicted largely by a difference in motivation for each type of exercise which, in turn, was based on differences in their beliefs about the anticipated benefits, enjoyment, and difficulty of performing each type of exercise during chemotherapy. These findings may help explain patient preference effects in unblinded behavioral trials.Trial registrationClinicalTrials.gov Identifier NCT00115713.

Project description:Women with breast cancer undergoing chemotherapy suffer from a range of detrimental disease and treatment related side-effects. Exercise has shown to be able to counter some of these side-effects and improve physical function as well as quality of life. The primary aim of the study is to investigate and compare the effects of two different exercise regimens on the primary outcome cancer-related fatigue and the secondary outcomes muscle strength, function and structure, cardiovascular fitness, systemic inflammation, skeletal muscle gene activity, health related quality of life, pain, disease and treatment-related symptoms in women with breast cancer receiving chemotherapy. The second aim is to examine if any effects are sustained 1, 2, and 5 years following the completion of the intervention and to monitor return to work, recurrence and survival. The third aim of the study is to examine the effect of attendance and adherence rates on the effects of the exercise programme.This study is a randomised controlled trial including 240 women with breast cancer receiving chemotherapy in Stockholm, Sweden. The participants are randomly allocated to either: group 1: Aerobic training, group 2: Combined resistance and aerobic training, or group 3: usual care (control group). During the 5-year follow-up period, participants in the exercise groups will receive a physical activity prescription. Measurements for endpoints will take place at baseline, after 16 weeks (end of intervention) as well as after 1, 2 and 5 years.This randomised controlled trial will generate substantial information regarding the effects of different types of exercise on the health of patients with breast cancer undergoing chemotherapy. We expect that dissemination of the knowledge gained from this study will contribute to developing effective long term strategies to improve the physical and psychosocial health of breast cancer survivors.OptiTrain - Optimal Training Women with Breast Cancer (OptiTrain), NCT02522260 ; Registration: June 9, 2015, Last updated version Feb 29, 2016. Retrospectively registered.

Project description:BackgroundUp to 60% of breast cancer patients treated with chemotherapy is confronted with cognitive problems, which can have a significant impact on daily activities and quality of life (QoL). We investigated whether exercise training improves cognition in chemotherapy-exposed breast cancer patients 2-4 years after diagnosis.MethodsChemotherapy-exposed breast cancer patients, with both self-reported cognitive problems and lower than expected performance on neuropsychological tests, were randomized to an exercise or control group. The 6-month exercise intervention consisted of supervised aerobic and strength training (2 h/week), and Nordic/power walking (2 h/week). Our primary outcome was memory functioning (Hopkins Verbal Learning Test-Revised; HVLT-R). Secondary outcomes included online neuropsychological tests (Amsterdam Cognition Scan; ACS), self-reported cognition (MD Anderson Symptom Inventory for multiple myeloma; MDASI-MM), physical fitness (relative maximum oxygen uptake; VO2peak), fatigue (Multidimensional Fatigue Inventory), QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ C-30), depression (Patient Health Questionnaire-9, Hospital Anxiety and Depression Scale; HADS), and anxiety (HADS). HVLT-R total recall was analyzed with a Fisher exact test for clinically relevant improvement (≥ 5 words). Other outcomes were analyzed using multiple regression analyses adjusted for baseline and stratification factors.ResultsWe randomized 181 patients to the exercise (n = 91) or control group (n = 90). Two-third of the patients attended ≥ 80% of the exercise sessions, and physical fitness significantly improved compared to control patients (B VO2peak 1.4 ml/min/kg, 95%CI:0.6;2.2). No difference in favor of the intervention group was seen on the primary outcome. Significant beneficial intervention effects were found for self-reported cognitive functioning [MDASI-MM severity (B-0.7, 95% CI - 1.2; - 0.1)], fatigue, QoL, and depression. A hypothesis-driven analysis in highly fatigued patients showed positive exercise effects on tested cognitive functioning [ACS Reaction Time (B-26.8, 95% CI - 52.9; - 0.6) and ACS Wordlist Learning (B4.4, 95% CI 0.5; 8.3)].ConclusionsA 6-month exercise intervention improved self-reported cognitive functioning, physical fitness, fatigue, QoL, and depression in chemotherapy-exposed breast cancer patients with cognitive problems. Tested cognitive functioning was not affected. However, subgroup analysis indicated a positive effect of exercise on tested cognitive functioning in highly fatigued patients. Trial Registration Netherlands Trial Registry: Trial NL5924 (NTR6104). Registered 24 October 2016, https://www.trialregister.nl/trial/5924 .

Project description:ObjectiveChemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment. There is no proven pharmacological application to prevent CIPN. This study was conducted to compare the effects of cold application and exercise on peripheral neuropathy development in patients with breast cancer who received taxane.MethodsThis was a multicenter clinical trial. The study was conducted as a randomized controlled trial on breast cancer patients who had chemotherapy-induced peripheral neuropathy complaints between July 2017 and January 2018 in an outpatient chemotherapy unit of training-research and a university hospital. A standardized, home-based, 12-week exercise program involved progressive strengthening, stretching, and balance exercises. Cold packs were applied for the duration of all 12 taxane infusions and then continued at home. The standard care protocol (information about side effects) of the clinic was used for patients in the control group. Data were collected via Patient Identification Form and CIPN Assessment Tool. Demographic data were evaluated by number and percentage ratios, and the study groups' mean scores were compared by Kruskal-Wallis and Wilcoxon analyses. The data were collected at two time points including baseline (T1) and week 12 (T2).ResultsThe study was completed with a total of 90 patients, so that each of the study groups, exercise, cold application, and control groups, included 30 patients. The mean of pre- and posttest results in the cold applied group revealed an increase in hand numbness, weakness, and distress (P < 0.05). However, no significant difference existed between the means of the pre- and the posttests in the exercise group (P = 0.79-0.1). The mean scores of all the symptoms in the control group except the loss of balance increased significantly (P < 0.05). Exercise reduced CIPN symptoms of numbness in hands (P = 0.009) and in the feet (P = 0.005) significantly compared to the cold application and control.ConclusionsIt was found that exercise was more effective than cold application in the management of CIPN.

Project description:BACKGROUND:Anthracyclines are chemotherapeutic agents frequently used in breast cancer (BC) treatment. Although it improves disease-free and overall survival, the use of anthracyclines is associated with a cumulative risk of cardiac toxicity. Preventive strategies to optimize cardiac health are needed and exercise is proposed as a potential non-pharmacological approach for counteracting anthracycline-related cardiotoxicity (ARC). Most of the data on the effects of exercise to reduce ACT are from animal studies, with only a few studies in a limited number of patients indicating beneficial effects. To better understand the effectiveness of exercise in the mitigation of ARC, clinical, real-world trials claim require a larger sample size and more accurate and valuable clinical biomarkers. In this study, we intend to include a large sample and investigate cardiac function through serial measures of biomarkers and imaging techniques. METHODS:This protocol describes a two-arm, prospective, randomized controlled trial that will explore the cardioprotective effect of a structured exercise program in women with BC undergoing anthracycline-containing chemotherapy (ACT). Ninety adult women with early BC and recommended to receive ACT will be randomly assigned (1:1) to an intervention group or a control group. Patients allocated to the intervention group will perform a supervised exercise program three times per week, consisting of a combination of aerobic and resistance training with progressive intensity and volume, during the time period they receive ACT. The control group will receive standard BC care. Primary outcomes related to cardiac (dys)function will be circulating N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, resting left ventricular (LV) longitudinal strain, and resting LV ejection fraction. Secondary outcomes will include the assessment of resting blood pressure, resting heart rate (HR), resting HR variability (HRV), recovery HR, physical function outcomes, self-reported physical activity level, health-related quality of life, and fatigue. Data will be obtained at baseline (t0), after the end of anthracycline-treatment (t2), and 3 months after t2 (t3). Additionally, NT-proBNP will be measured 1-24 h prior to each anthracycline-treatment cycle (t1). DISCUSSION:The implementation of the present study design, using novel clinical biomarkers, will determine the effect of structured exercise interventions at mitigating ARC, with the overall aim of finding means to further improve BC care. TRIAL REGISTRATION:ISRCTN, ISRCTN32617901 . Registered on 24 October 2018. Last updated on 11 January 2019.

Project description:BackgroundVisceral adipose tissue (VAT) is a strong risk factor for cardiovascular disease and increases with age. While supervised exercise (SE) may be an effective approach, web-based exercise (WE) have other advantages such as being more readily accessible. Therefore, we evaluated the effects of WE on VAT, body composition and cardiometabolic risk markers in centrally obese older adults and compared the effects of WE to SE. We also explored the feasibility of WE.MethodsIn a randomized controlled trial conducted in Umeå, Sweden during January 2018 - November 2018, N = 77, 70-year-old men and women with central obesity (> 1 kg VAT for women, > 2 kg for men) were randomized to an intervention group (n = 38) and a wait-list control group (n = 39). The intervention group received 10 weeks of SE while the wait-list control group lived as usual. Following a 10-week wash-out-period, the wait-list control group received 10 weeks of WE. The primary outcome was changes in VAT. Secondary outcomes included changes in fat mass (FM), lean body mass (LBM), blood lipids, fasting blood glucose. Additionally, we explored the feasibility of WE defined as adherence and participant experiences.ResultsWE had no significant effect on VAT (P = 0.5), although it decreased FM by 450 g (95% confidence interval [CI], 37 to 836, P < 0.05). The adherence to WE was 85% and 87-97% of the participants rated aspects of the WE intervention > 4 on a scale of 1-5. Comparing SE to WE, there was no significant difference in decrease of VAT (Cohen's δ effect size [ES], 0.5, 95% CI, - 24 to 223, P = 0.11), although SE decreased FM by 619 g (ES, 0.5, 95% CI, 22 to 1215, P < 0.05) compared to WE.ConclusionsTen weeks of vigorous WE is insufficient to decrease VAT in centrally obese older adults, but sufficient to decrease FM while preserving LBM. The high adherence and positive experiences of the WE intervention implies that it could serve as an alternative exercise strategy for older adults with central obesity, with increased availability for a larger population.Trial registrationClinicalTrials.gov (NCT03450655), retrospectively registered February 28, 2018.

Dataset Information

A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial.

Publications

A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial.

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