A Randomized Controlled Trial of Home-Based Exercise for Cancer-related Fatigue in Women during and after Chemotherapy with or without Radiation Therapy

Marylin J. Dodd, PhD, RN, FAAN; Maria H. Cho, PhD, RN; Christine Miaskowski, PhD, RN, FAAN; Patricia L. Painter, PhD; Steven M. Paul, PhD; Bruce A. Cooper, PhD; John Duda, RN; Joanne Krasnoff, PhD; Kayee A. Bank, MSN, RN

Disclosures

Cancer Nurs. 2010;33(4):245-257. 

In This Article

Abstract and Introduction

Abstract

Background: Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment.
Objective: The purpose of this study was to evaluate the effectiveness of a home-based exercise training intervention, the Pro-self Fatigue Control Program on the management of cancer-related fatigue.
Interventions/Methods: Participants (N = 119) were randomized into 1 of 3 groups: group 1 received the exercise prescription throughout the study; group 2 received their exercise prescription after completing cancer treatment; and group 3 received usual care. Patients completed the Piper Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies-Depression Scale, and Worst Pain Intensity Scale.
Results: All groups reported mild fatigue levels, sleep disturbance, and mild pain, but not depression. Using multilevel regression analysis, significant linear and quadratic trends were found for change in fatigue and pain (ie, scores increased, then decreased over time). No group differences were found in the changing scores over time. A significant quadratic effect for the trajectory of sleep disturbance was found, but no group differences were detected over time. No significant time or group effects were found for depression.
Conclusions: Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined.
Implications for Practice: Clinicians need to be aware that some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. Further analysis is needed to examine the adherence to exercise. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise.

Introduction

Cancer-related fatigue (CRF) is a common problem in oncology patients and survivors that has received attention during the last 2 decades. Although the reported prevalence of CRF varies across studies, a consensus exists that it is high both during and after cancer treatment. In addition, numerous studies suggest that increased levels of fatigue are positively associated with sleep disturbance, depression, and pain and that these symptoms have a negative impact on functional status and quality of life. Although the underlying mechanisms of CRF are yet to be established, the effects of exercise on CRF and other patient outcomes have been the subject of numerous studies and suggest that exercise may have a positive effect on some symptoms.[1]

In fact, in a series of systematic reviews and meta-analyses in patients with cancer,[2–16] the physiological and psychological benefits of cardiovascular exercise interventions have been enumerated, including improvement in functional capacity,[12,15–18] physical functioning,[2,14,18] and cardiopulmonary fitness;[7,11,13,15,19–21] increased lean body mass;[2,8,13,22] reduction in fatigue;[2,7,9,12–14,17,23–27] improvement in mood and increase in vigor;[2,9,11] decrease in depression;[17,24,28–32] improvement in sleep;[11,24] and improvement in quality of life.[7,10,13,17,18,20,23,28,32–36]

All of these studies are limited by timing, structure, and/or duration of the exercise interventions. Most of the exercise interventions were conducted only during cancer treatment, consisted of predominately supervised aerobic activities performed in a physical activity facility at moderate intensity several times a week for 20 to 30 minutes per session from 5 weeks to 3 months in duration. No studies were found that evaluated an individualized exercise prescription for home-based exercise training during as well as after cancer treatment. Therefore, the primary purpose of this study was to evaluate the effectiveness of a home-based exercise training intervention called the Pro-self: Fatigue Control Program on the management of CRF. Secondary purposes were to investigate the timing of intervention, either during or after completion of cancer treatment on CRF, and to study the effects of the intervention on sleep disturbance, depression, and pain.

The Effect of the Exercise Intervention on CRF

Seven systemic reviews and meta-analyses have reported on the effects of exercise as an intervention for CRF in oncology patients.[2,9,11–13,37,38] In this section, the results of studies of exercise interventions' effects on CRF are summarized. McNeely et al[12] reviewed 14 randomized controlled trials (RCTs) of breast cancer women and survivors, of which 6 trials assessed the effect of exercise on CRF. Four of the 6 studies[18,19,39,40] used the revised Piper Fatigue Scale (PFS). Although all 6 studies showed improvements in fatigue with exercise on either home based or supervised, only 2 reported statistically significant improvements. These 2 studies were the ones conducted with breast cancer survivors who were on a mean of 14 (SD, 6) months past their completion of treatment[20] or 21 (SD, 18) months since their cancer diagnosis.[41]

In a more recent study, Schneider et al[42] used 2 separate samples to test the effectiveness of an exercise intervention on fatigue and cardiopulmonary function in patients with breast cancer. Women participated in an individualized prescribed exercise program during cancer treatment (n = 17) or after cancer treatment (n = 96). The intervention included both aerobic and resistance activities. Participants attended individually supervised exercise sessions 2 or 3 d/wk for 6 months. The exercise session lasted 60 minutes that included warm-up, 40 minutes of aerobic exercise resistance training and stretches, and 10 minutes of cooldown. Exercise intensity ranged from 40% to 75% of heart rate reserve. Exercise options included outdoor or treadmill walking or stationary cycling. Intensity was measured by the Borg Exertion Scale (range, 0–10; 0 = no exertion, 10 = maximal exertion). Self-reported intensity of exercise began at a Borg Scale rating of 2 (of 10) and progressed as tolerated. The patients who received the exercise intervention while in active cancer treatment showed statistically significant improvements in cardiopulmonary function, 2 subscales of the PFS (ie, behavioral and sensory), and in total PFS score. The patients who received the intervention after cancer treatment showed improvements in cardiopulmonary function (eg, improved systolic blood pressure, time on treadmill), all 5 of the PFS subscales (ie, behavior, sensory, affective, cognitive, and mood), and in total PFS score.

Somewhat similar results were obtained when these authors reported on 45 men with various cancer diagnoses, who participated in the same study.[43] These men were divided into during-treatment and following-treatment groups. They received the same 6-month individualized exercise prescription as described earlier. Fatigue was significantly reduced (ie, all 5 subscales and total PFS score) with the exercise intervention in men who had completed their cancer treatment, but not in the men who received the intervention during treatment. In a similar, yet retrospective study,[44] significant reductions in CRF were found at 8 weeks following an individualized comprehensive exercise program that was administered during and after cancer treatment in patients who were receiving cancer treatment (n = 13) and in cancer survivors who had completed their cancer treatment (n = 26). The intervention included supervised aerobic and resistance exercise, educational classes, and support. The outcome measures were retrieved from medical records. Significant improvement was seen in the total PFS score. The sample included 13 different types of cancer; 15 of the 39 had breast cancer. These patients were a decade older (mean, 63 years) and had a more advanced cancer (6/39 stage IV) than comparable earlier studies.

Unlike the previous findings of positive outcomes of exercise interventions during cancer treatment, McNeely et al[12] reported on 5 home-based exercise intervention studies that had mixed findings. Four of the 5 studies were conducted during adjuvant cancer treatment and did not find significant improvements in CRF in patients who received the exercise intervention. Similar findings were also reported by a large randomized clinical trial of 245 patients with breast cancer who received a 17-week intervention of supervised aerobic or resistance exercises during their adjuvant chemotherapy.[41,45] In the follow-up study, Pinto et al (2008)[46] found an initial improvement in CRF at the end of the 12-week intervention. However, these improvements were not sustained 6 months later. Of note, at the 9-month follow-up, some of the initial improvements in CRF were regained.

The translation of benefits from exercise interventions to clinical practice occurred rapidly through Oncology Nursing Society's Putting Evidence Into Practice Project.

Currently, considerable enthusiasm exists for recommending exercise during and after cancer treatment, despite limited data on the most effective timing of the exercise intervention and inconsistent data concerning the relationship of exercise with fatigue management during adjuvant cancer treatment. In addition, studies of the effects of exercise immediately following the completion of cancer treatment are extremely limited.

Exercise Recommendations and Guidelines

Prior to 2000, there were no cancer-specific exercise testing, prescription, or training guidelines. As a result, most published intervention studies based their prescriptions on the 1998 American College of Sports Medicine (ACSM) guidelines for healthy adults.[47,48] The American Cancer Society[49] recommended that aerobic activity be performed 3 to 5 d/wk for 20 to 60 minutes per session at a moderate level of intensity. According to Schwartz,[50] in her review of physical activity and cancer patients, clinicians should recommend aerobic exercise at least every other day at moderate intensity (50%-75% predicted maximum heart rate or 10–14 on the 20-point Borg Scale or symptom limited) for at least 30 minutes per session. Prudent exercise guidelines include starting an exercise program with short duration, low intensity (below their perceived ability), and slowly progressing to continuous longer-duration, moderate-intensity exercise.[50] The optimum exercise prescription for individual cancer patients has not been fully elucidated.

Conceptual Framework of the Study

Cancer-related fatigue was defined as a subjective sensation of unusual whole-body tiredness due to cancer.[51] The literature suggests that a variety of factors may contribute to CRF. These factors include changes in functional status, activity levels, psychological factors, sleep disturbances, disease, treatment and symptom factors, and diverse inherent or innate factors (eg, demographic, disease, and treatment variables).[51–61] The most frequently cited theoretical framework for fatigue that addresses these factors in cancer patients is the Integrated Fatigue Model (IFM).[51,59,62,63] The Integrated Fatigue Model provided the framework for the current study. Cancer-related fatigue is the primary outcome variable of the study, and sleep disturbance, depression, and pain were viewed as fatigue-related variables and therefore were secondary outcomes. In addition, innate factors were also considered as possible moderators of CRF. The PFS was derived from the IFM and was used to measure the multidimensional characteristics of CRF.

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