Thorsen 2005.
| Study characteristics | ||
| Methods | Study design: RCT Number randomized: 139; 69 to the exercise group and 70 to the control group Study start and stop dates: not reported Length of intervention: 14 weeks Length of follow‐up: to end of the intervention |
|
| Participants | Type cancer, n: lymphoma, 25; breast, 42; gynecologic, 24; testicular, 20
Time since cancer diagnosis: not reported Time beyond active treatment, mean (SD) days: 28 (9) days Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender, n (%):
Current age, mean (SD) years:
Age at cancer diagnosis: 39 years Ethnicity/race: not reported Education level: not reported SES: not reported Employment status: not reported Other, BMI, mean (SD) kg/m2:
Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
|
| Interventions | 69 participants assigned to the exercise group, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: 13 to 15 on Borg perceived exertion scale (where the score range from 6 to 20, and a value of 6 means no exertion at all and 20 means maximal exertion) and 60% to 70% of maximum HR if using a HR monitor Frequency: twice a week Duration of sessions: 30 minutes Duration of program: 14 weeks Total number of exercise sessions: 28 Format: individual Facility: home Professionally led: exercise instructor Adherence: 30 (51%) of participants reported being "physically active" during the treatment period Co‐intervention: none 70 participants were assigned to the control group, including:
Contamination of control group: 24 (46%) of participants reported being "physically active" during the treatment period |
|
| Outcomes | Primary outcome: physical outcome, measured by:
Secondary outcomes: QoL outcomes, including:
Outcomes were measured at baseline and 14 weeks:
Adverse events: none reported |
|
| Notes | Country: Norway Funding: Norwegian Foundation for Health and Rehabilitation and The Norwegian Cancer Society |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computerized random assignment" |
| Allocation concealment (selection bias) | Low risk | "The Norwegian Radium Hospital was responsible for computerized random assignment" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Study personnel and outcome assessors were not masked or blinded to the study interventions |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Although the authors stated that the ITT analysis was used, 10 participants in the exercise group withdrew and 18 participants in the control group withdrew |
| Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
| Other bias | Low risk | The trial appears to be free of other problems that could put it at a high risk of bias |
1‐RM: 1‐repetition maximum; ACSM: American College of Sports Medicine; AIDS: acquired immune deficiency syndrome; ALL: acute lymphoblastic leukemia; AML: acute myeloid leukemia; BDI: Beck Depression Inventory; BES: Body Esteem Scale; BIQ: Body Image Questionnaire; BMI: body mass index; CARES‐SF: Cancer Rehabilitation Evaluation System Short Form; CCS: Canadian Cancer Society; CES‐D: Centers for Epidemiologic Studies ‐ Depression scale; CI: confidence interval; DCIS: ductal carcinoma in situ; ECOG: Eastern Cooperative Oncology Group; EORTC QLQ‐C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module; EWB: emotion well‐being; FACIT‐F: Functional Assessment in Chronic Illness Therapy ‐ Fatigue; FACIT‐Sp: Functional Assessment of Chronic Illness Therapy ‐ Spiritual; FACT‐An: Functional Assessment of Cancer Therapy ‐ Anemia; FACT‐B: Functional Assessment of Cancer Therapy ‐ Breast; FACT‐C: Functional Assessment of Cancer Therapy ‐ Colorectal; FACT‐Cog: Functional Assessment of Cancer Therapy ‐ Cognitive Function; FACT‐ES: Functional Assessment of Cancer Therapy ‐ Endocrine Symptoms; FACT‐F: Functional Assessment of Cancer Therapy ‐ Fatigue; FACT‐G: Functional Assessment of Cancer Therapy ‐ General; FACT‐Lym: Functional Assessment of Cancer Therapy ‐ Lymphoma; FACT‐Sp: Functional Assessment of Cancer Therapy ‐ Spirituality; FWB: functional well‐being; GED: General Education Diploma; GVHD: graft‐versus‐host disease; HADS: Hospital Anxiety and Depression Scale; HL: Hodgkin lymphoma; HNC: head and neck cancer; HR: heart rate; HRQoL: health‐related quality of life; HSCT: hematopoietic stem cell transplant; ITT: intention to treat; KPS: Karnofsky Performance Status; LASA: Linear Analog Self‐Assessment; LSI: Leisure Score Index; MAC: Mental Adjustment to Cancer; MFI: Multidimensional Fatigue Inventory; MOS SF‐12: Medical Outcomes 12‐Item Short Form Health Survey; MOS SF‐36: Medical Outcomes 36‐Item Short Form Health Survey; MCS: mental component status; MFSI‐SF: Multidimensional Fatigue Symptom Inventory Short Form; NCIC: National Cancer Institute of Canada; NHL: non‐Hodgkin lymphoma; NIH: National Institutes of Health; NYHA: New York Heart Association; PANAS: Positive and Negative Affect Schedule; PCS: physical component status; POMS: Profile of Moods Scale; PRET: progressive resistance exercise training; PSQI: Pittsburgh Sleep Quality Index; PWB: physical well‐being; QoL: quality of life; RCT: randomized controlled trial; ROM: range of motion; rPAR‐Q: revised Physical Activity Readiness Questionnaire; RPE: ratings of perceived exertion; RSE: Rosenberg Self‐Esteem; SCFC: Schwartz Cancer Fatigue Scale; SCL‐90‐R: Symptom Checklist‐90 Revised; SD: standard deviation; SES: socioeconomic status; SFT: Submaximal Fitness Test; SOSI: Symptoms of Stress Inventory; SPADI: Shoulder Pain and Disability Index; SPAS‐7: Social Physique Anxiety Scale‐7 items; STAI: State‐Trait Anxiety Index; SWB: social/family well‐being; SWLS: Satisfaction with Life Scale; TOI: Trial Outcome Index; TOI‐An: Trial Outcome Index ‐ Anemia; TTM: Trans Theoretical Model; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index.