Yang 2011.
| Methods | RCT, 2 groups Study start and stop dates: 2008 to 2009 Length of intervention: 12 weeks Length of follow‐up: end of intervention |
|
| Participants | 44 sedentary breast cancer patients randomised, 40 completed the study | |
| Interventions | Intervention group (n = 19): home‐based walking program, developed using the American College of Sports Medicine guidelines. Walking starting 2 to 3 days after each chemotherapy session, included 5 minutes warm‐up, 30 minutes brisk walking (60% to 80% of age‐adjusted HRmax), 5 minutes cool‐down Control group (n = 21): maintenance of their previous lifestyle for 12 weeks |
|
| Outcomes |
Outcomes measured at baseline, 6 and 12 weeks |
|
| Notes | Funding: Taipei Medical University Hospital (95TMU‐TMUH‐19), Taipei, Taiwan, Republic of China. Conflict of interest: None declared |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants All outcomes | High risk | Not done |
| Blinding of personnel/care providers All outcomes | High risk | Not reported. Comment: probably not done |
| Blinding of outcome assessment (detection bias) All outcomes except fitness outcomes | High risk | Self reported items |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out:
Total: 4/44 (9%) |
| Selective reporting (reporting bias) | Unclear risk | No study protocol published, study not registered prospectively |
| Group similarity at baseline | Low risk | The groups were generally balanced at baseline regarding demographic and disease‐related characteristics |
| Adherence | High risk | "About 20% did not completely adhere." Adherence was about 77% of the prescribed exercise sessions and 100% of the prescribed exercise intensity |
| Contamination | Unclear risk | Not reported |
6‐MWT: 6‐minute walk test ACSM: American College of Sports Medicine BDI: Beck Depression Inventory BMI: body mass index CES‐D: Center for Epidemiological Studies‐Depression Scale DASH: Disabilities of the Arm, Shoulder and Hand Questionnaire DEXA: dual‐energy X‐ray absorptiometry EORTC QLQ‐BR23: European Organisation for Research and Treatment of Cancer Breast Cancer‐Specific Quality of Life Questionnaire EORTC QLQ‐C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐Core 36 FACIT‐F: Functional Assessment of Chronic Illness Therapy‐Fatigue Scale FACT‐An: Functional Assessment of Cancer Therapy‐Anaemia FACT‐B: Functional Assessment of Cancer Therapy‐Breast FACT‐ES: Functional Assessment of Cancer Therapy‐Endocrine Symptoms FACT‐G: Functional Assessment of Cancer Therapy‐General FACT‐Taxane: Functional Assessment of Cancer Therapy‐Taxane FQL: Fatigue Quality List GLTEQ: Godin Leisure‐Time Exercise Questionnaire GXT: Graded Exercise Test HADS: Hospital Anxiety and Depression Scale HRmax: maximum heart rate HRQoL: health‐related quality of life IPAQ: International Physical Activity Questionnaire IQR: interquartile range ITT: intention‐to‐treat L‐Dex: lymphoedema index MDASI‐T: Taiwanese version of the MD Anderson Symptom Inventory MET: metabolic equivalent of task MFI: Multidimensional Fatigue Inventory MOS SF‐36: Medical Outcomes Study 36‐Item Short Form Health Survey MQOLS‐CA: Multidimensional Quality of Life Scale‐Cancer MVPA: moderate to vigorous physical activity QoL: quality of life QR: Quartile Range PAL: physical activity level PANAS: Positive and Negative Affect Schedule PFS: Piper Fatigue Scale POMS: Profile of Mood States RCT: randomised controlled trial SD: standard deviation SF‐36: 36‐Item Short Form Health Survey SPAQ: Scottish Physical Activity Questionnaire SWLS: Satisfaction With Life Scale VO2 max: maximal oxygen uptake