POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment

Abstract

BackgroundPatients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment. Therefore, the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a randomized controlled setting.Methods/designThe POSITIVE study is a randomized, controlled trial investigating the effects of a 24-week exercise intervention during palliative treatment on quality of life, physical performance and immune function in advanced, non-operable lung cancer patients. 250 patients will be recruited in the Clinic for Thoracic Diseases in Heidelberg, enrolment begun in November 2013. Main inclusion criterion is histologically confirmed NSCLC (stage IIIa, IIIb, IV) or SCLC (Limited Disease-SCLC, Extensive Disease-SCLC) not amenable to surgery. Patients are randomized into two groups. Both groups receive weekly care management phone calls (CMPCs) with the goal to assess symptoms and side effects. Additionally, one group receives a combined resistance and endurance training (3x/week). Primary endpoints are quality of life assessed by the Functional Assessment of Cancer Therapy for patients with lung cancer (FACT-L, subcategory Physical Well-Being) and General Fatigue measured by the Multidimensional Fatigue Inventory (MFI-20). Secondary endpoints are physical performance (maximal voluntary isometric contraction, 6-min walk distance), psychosocial (depression and anxiety) and immunological parameters and overall survival.DiscussionThe aim of the POSITIVE trial is the evaluation of effects of a 24-week structured and guided exercise intervention during palliative treatment stages. Analysis of various outcomes (such as quality of life, physical performance, self-efficacy, psychosocial and immunological parameters) will contribute to a better understanding of the potential of exercise in advanced lung cancer patients. In contrast to other studies with advanced oncological patients the POSITIVE trial provides weekly phone calls to support patients both in the intervention and control group and to segregate the impact of physical activity on quality of life.Trial registrationClinicalTrials.gov NCT02055508 (Date: December 12, 2013)

Physical Fitness, Exercise Self-Efficacy, and Quality of Life in Adulthood: A Systematic Review

“…Related to active living and physical exercise is the concept of physical fitness, a well-known and powerful health marker [ 18 , 19 , 20 ] among middle-aged populations, it is even more powerful than physical activity [ 7 ] but we must understand physical fitness as a concept broader than one related exclusively to biological health; it can be defined as the ability to carry out daily tasks with vigor and liveliness, without excessive fatigue, and with enough energy remaining to enjoy leisure time or to cope with unexpected emergencies [ 21 ]. Therefore, in addition to being related to biological health, physical fitness is also closely related to psychosocial factors on the human spectrum and has been found to influence fitness parameters [ 22 ].…”

Physical activity for people with lung cancer

“…Few adequately powered RCTs are published to date examining exercise for patients undergoing non-surgical treatments, although several trials are nearing completion internationally. 45,46 For patients with advanced lung cancer, a Cochrane review of exercise training, which included six RCTs, reported significant improvements in exercise capacity and disease-specific HRQoL favouring the intervention group but no differences in dyspnoea, mood or respiratory function. 47 Included studies were rated as low quality.…”

Chronic Obstructive Pulmonary Disease and Lung Cancer: Underlying Pathophysiology and New Therapeutic Modalities

“…In addition, pre-operative exercise training was associated with improved lung function recovery after surgery and reduced post-operative pulmonary complications (51,73). In a study by Licker et al that investigated the effectiveness of preoperative exercise training on postoperative outcomes in people undergoing lung resection for NSCLC, independent predictors of postoperative pulmonary complications were preoperative peakVO2, pre-operative exercise training, and COPD [56,57].…”

“…In patients with advanced lung cancer exercise training programmes should aim to prevent deterioration in important clinical outcomes, control symptoms and maximise independence. This is an area of growing interest amongst researchers and clinicians, and there are several RCTs being conducted to investigate effectiveness of exercise training in this population [56][57][58]. To date, exercise training has been shown to be feasible and safe in patients with advanced lung cancer [59].…”