1. Dr. Hui-Mei Chen National Taipei University of Nursing and Health Sciences, Taipei, Taiwan Randomised Controlled Trial on the Effectiveness of Home-Based Walking Exercise on Depression in Patients with Lung Cancer 1

2. Background The proportion of lung cancer survivors is growing worldwide and in Taiwan. (Forman, 2013; Ministry of Health and Welfare, 2013)Forman, 2013Ministry of Health and Welfare, 2013 Patients with lung cancer frequently experience psychological problems, such as depression. The prevalence rate of depression in lung cancer survivors is 33%. (Hopwood & Stephens, 2000).Hopwood & Stephens, 2000 Depression might limit the functional ability and impair the quality of life (QOL) in lung cancer survivors. 2

3. Literature Review Although exercise provides several benefits for patients with cancer, the effect of exercise on have been inconsistently reported in various studies. As demonstrated by 2 previous studies, exercise can reduce depression in patients with breast cancer and other cancers (Mehnert et al, 2011; Midtgaard et al, 2011). However, 4 previous studies have indicated that exercise intervention is ineffective in reducing depression in the patient population with breast, lung, colorectal, and other cancers. (Duijts et al, 2012; Jacobsen et al, 2013; Lin et al, 2014; Temel et al, 2009)Mehnert et al, 2011Midtgaard et al, 2011Duijts et al, 2012Jacobsen et al, 2013Lin et al, 2014Temel et al, 2009 3

4. Literature Review (con’t) These studies have involved the use of various exercise modalities (eg, brisk walking, running, cycling, swimming and resistance training), including various exercise modes with varying frequency, intensity and duration, thereby resulting in inconsistent conclusions. The American College of Sports Medicine (2010) suggested that patients with cancer must perform moderate-intensity aerobic exercises such as walking and cycling for 20–60 min per session for 3–5 days per week to improve mood and QOL and reduce fatigue. (Schmitz et al, 2010)Schmitz et al, 2010 Walking is strongly recommended for patients with pulmonary diseases because it is involved in most activities of daily living (ADL). (American College of Sports Medicine, 2006)American College of Sports Medicine, 2006 4

5. Literature Review (con’t) Walking is the most preferred exercise of patients with lung cancer because it is flexible and can be performed alone in Taiwanese patients with lung cancer. (Lin et al, 2013)Lin et al, 2013 A home-based, moderate-intensity walking programme can reduce depression in patients with breast and colorectal cancers (Courneya et al, 2003) ; however, research on the effects of home- based walking exercise on patients with lung cancer remains limited.Courneya et al, 2003 5

6. Research Purpose The current study aimed to determine the effectiveness of a 12-week home-based walking-exercise programme in managing depression in Taiwanese patients with lung cancer. 6

7. Methods- Research Design and Study Sample We conducted a parallel, randomised, controlled and single- centre trial with a home-based walking-exercise group and a usual-care group. Eligibility criteria: patients who were diagnosed with primary lung cancer, were aged ≥ 18 years, were able to speak Mandarin or Taiwanese and exhibited no cognitive impairment. 7

8. Methods- Research Design and Study Sample(con’t) Excluded criteria:(1) had engaged in regular exercise (150 min/wk, moderate intensity) or had received cognitive behaviour therapy in the past 6 months; (2) had been diagnosed with congestive heart disease; (3) had been diagnosed with lower limb orthopaedic diseases that restrict walking ability; or (4) had been diagnosed with repeated onset of depression. The study protocol was approved by the Institutional Review Board of Taipei Veterans General Hospital (Taipei, Taiwan). 8

9. Methods- Procedure Baseline assessment (T1) at the hospital. Follow-up questionnaires were distributed by post during the third (T2) and sixth (T3) months. 9

10. Methods- Intervention The exercise programme was a 12-week home-based, moderate-intensity walking-exercise programme consisting of 40 minutes per session, 3 sessions per week, and weekly exercise counselling. During the enrolment period, we offered a walking-exercise booklet to the participants, and used its contents to instruct the patients regarding the mode, intensity and frequency of exercise; pulse-rate measurement; Borg's rating of perceived exertion (RPE) scale (6–20) (Borg, 1998) ; prevention of sports injuries; and the time-point of terminating the exercise.Borg, 1998 Each participant was instructed to achieve a target heart rate of 60%–80%, based on the Karvonen method (Karvonen et al, 1957), and a score of 13–15 on the RPE scale.Karvonen et al, 1957 10

11. Methods- Study Measures Using the Hospital Anxiety and Depression Scale- depression subscale (HADS-D) (Zigmond & Snaith, 1983), which comprises 7 items for depression. Each item of the depression subscale (HADS-D) was scored on a 4-point scale from 0 (not at all) to 3 (very much so).Zigmond & Snaith, 1983 Higher scores indicated higher depression levels. Subscale scores of ≥11 were considered to indicate a ‘definite case’, whereas subscale scores of 8 to 10 and 0 to 7 were considered to be a ‘suspicious case’ and a ‘noncase’, respectively, of depression (Zigmond & Snaith, 1983).Zigmond & Snaith, 1983 11

12. Methods- Statistical Analysis We used an intention-to-treat (ITT) approach. All statistical analyses were conducted using the IBM Statistical Package for the Social Sciences (SPSS) (Version 20) for Windows (IBM, Somers, NY, USA). Both stability and repeated relationship analyses were conducted using generalised estimation equations (GEE). We added an interaction term (group difference  time) to each model to investigate the cooperative effect of exercise and time. The changes in study outcome values (depression) from baseline to follow-up periods (third and sixth months) were expressed in both the walking-exercise and usual-care groups. 12

13. RESULTS- Participant Characteristics 13

14. RESULTS- Intervention Effects on Depression 14

15. RESULTS- Intervention Effects on Depressi on 15

16. RESULTS- Intervention Effects on Depression 16

17. RESULTS- Intervention Effects on Depression According to the Clinical Cutoff Point 17 suspicious case & definite case Clinical significant

18. DISCUSSION This is the first study to investigate the psychological effects of a home-based walking exercise programme on patients with lung cancer. The trial results support the hypothesis that a home-based walking exercise exerts positive effects on depression in patients with lung cancer. These results are consistent with those obtained in previous studies on patients with colorectal and breast cancer (Courneya et al, 2003; Mehnert et al, 2011; Mock et al, 1997).Courneya et al, 2003Mehnert et al, 2011Mock et al, 1997 Our results indicate that the psychological benefits of exercise observed in other cancer populations apply to patients with lung cancer as well. 18

19. DISCUSSION(con’t) Regarding exercise intensity, because of the constraints of our research budget, we used both the heart rate and Borg's RPE, which were measured by the patients themselves; however, accurate heart rate detection can be challenging for elderly people. We suggest that a future study with a larger budget use watch- like heart rate monitors to facilitate precise heart rate detection; this would reduce the measurement error when patients measure their own heart rate as well as the patient load for heart rate measurement, particularly on elderly patients. 19

20. DISCUSSION(con’t) In the walking-exercise group, 14 (24.1%) patients dropped out, and 11 (19.0%) patients in the usual-care group dropped out. The patients who dropped out exhibited higher depression scores than did the nondropout patients. This finding is similar to that of a study on patients enrolled in a cardiac rehabilitation programme; the depression status served as a predictor of the number of exercise sessions completed and the dropout rate (Glazer et al, 2002).Glazer et al, 2002 We suggest that health care providers conduct regular follow- ups of the depression status of patients, and encourage them to continue exercising when conducting an exercise programme. 20

21. Strength and Limitation The strengths of this trial include it being the first home-based walking-exercise, randomised controlled trial to focus on Taiwanese patients with lung cancer; and the adoption of a feasible and flexible exercise programme. Although, the lack of blinding is inevitable in this type of study, it may have induced a placebo effect on the patients and an observational bias among the researchers; therefore, the outcome assessors should be trained in standardized testing procedures to reduce bias. Three patients reported that they could not endure the moderate-intensity exercises during the first and second weeks; this negatively affected the intervention fidelity and possibly diluted the intervention effect. 21

22. CONCLUSION This study is the first to document evidence regarding the feasibility and effectiveness of walking-exercise training programmes in patients with lung cancer. The study results suggest that home-based walking exercise can reduce depression, and elucidate the critical role of exercise in the rehabilitation of patients with cancer. Health care team members must comprehend and consider exercise as a supportive care intervention for lung cancer survivors. 22

23. Thank You for Your Attention E-mail:alice@ntunhs.edu.tw 23