| Study characteristics |
| Methods |
Study design: RCT
Number randomized: 41; 21 to the exercise group and 20 to the control group
Study start and stop dates: recruitment from April 2006 to May 2007
Length of intervention: 12 weeks
Length of follow‐up: 3 months after end of the intervention |
| Participants |
Type cancer: breast
Cancer stage, Stage I to III, n (%):
exercise group: Stage I, 6 (29%); Stage II, 11 (52%); Stage III, 4 (19%) control group: Stage I, 6 (30%); Stage II, 10 (50%); Stage III, 4 (20%)
Time since cancer diagnosis: not reported
Time beyond active treatment:
exercise group, mean (SD) months: months since surgery [n = 21(100%)], 35 (38) months; months since chemotherapy [n = 17 (81%)], 36 (39) months; months since radiation [n = 18 (86%)], 35 (41) months control group, mean (SD) months: months since surgery [n = 20 (100%)], 34 (30) months; months since chemotherapy [n = 17 (85%)], 30 (31) months; months since radiation [n = 6 (80%)], 30 (31) months
Inclusion criteria:
female 18 to 70 years old history of stage I, II, or IIIA breast cancer English speaking currently taking an aromatase inhibitor or estrogen receptor modulator medical clearance provided by physician at least 8 weeks postsurgery
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
dementia or organic brain syndrome medical, psychological, or social characteristic that would interfere with the ability to fully participate in program activities and assessments contraindication to participate in a regular physical activity program (e.g. unstable angina, debilitating arthritis pain) inability to ambulate plans to relocate outside the study area during the study period breast cancer recurrence or metastasis.
Gender: female
Current age, mean (SD) years:
Age at cancer diagnosis: not reported
Ethnicity/race, n (%):
exercise group: white, 19 (90%); other, 2 (10%) control group: white, 19 (95%); other, 1 (5%)
Education level, mean (SD) years:
SES household income, n (%):
exercise group: < USD10,000, 1 (5%); USD10,000 to USD35,000, 7 (33%); USD35,000 to USD50,000, 3 (14%); > USD50,000, 10 (48%) control group: < USD10,000, 1 (5%); USD10,000 to USD35,000, 0 (0%); USD35,000 to USD50,000, 5 (25%); > USD50,000, 14 (70%)
Employment status: not reported
Comorbidities:
Past exercise history: not reported
On hormone therapy:
exercise group: months on hormonal therapy, mean (SD) months, 15 (15) months; estrogen receptor modulator, n (%), 7 (33%); aromatase inhibitor, n (%), 14 (67%) control group: months on hormonal therapy, mean (SD) months, 22 (18) months; estrogen receptor modulator, n (%), 4 (20%); aromatase inhibitor, n (%), 16 (80%)
|
| Interventions |
21 participants assigned to the exercise group, including:
6 discussion group sessions with a clinical psychologist at baseline, and weeks 1, 2, 4, 6, and 8 6 supervised exercise programs (walking), 3 per week during weeks 1 and 2, 2 per week during weeks 3 and 4, and 1 per week during weeks 5 and 6 40 home‐based exercise (walking), 2 per week during weeks 3 and 4, 3 per week during weeks 5 and 6, 5 per week during weeks 7 through 12 3 individual update counseling sessions with an exercise specialist during week 8, 10, and 12
Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: transition from baseline to week 12 to 150 minutes of moderate‐intensity activity
Frequency: gradually increased from 3 times a week to 5 times a week
Duration of sessions: not reported
Duration of program: 12 weeks
Total number of exercise sessions: 52
Format: individual exercise; group peer support
Facility: facility and home
Professionally led: exercise specialists certified (or certification‐eligible) by the ACSM
Adherence: participants completed 100% (252/252) of the individual exercise sessions, 95% (60/63) of the individual update sessions, and 98% (123/126) of the group session for overall 99% (435/441) adherence. 6% (4/63) of update sessions were completed by telephone
20 participants were assigned to the control group, including:
Contamination of control group: not reported |
| Outcomes |
Outcomes: QoL outcomes and physiologic outcomes, including
FACT‐B, including subscales of physical functioning, SWB, EWB, FWB, and additional concerns FACT‐G, the sum of the physical functioning, SWB, EWB, and FWB FACT‐F, a 13‐item instrument FACT‐Cog, a 42‐item instrument FACT‐ES, a 19‐item instrument sleep dysfunction, assessed using the PSQI joint pain, stiffness, and physical function, using a 5‐point Likert scale version (1 = none to 5 = extreme) of the 24‐item WOMAC objective activity monitoring, measured using a GT1M accelerometer self‐reported leisure time physical activity, assessed using the Godin Leisure‐Time Exercise Questionnaire stage of motivational readiness for physical activity, classified as precomtemplation, contemplation, preparation, action, and maintenance fitness, assessed using a submaximal treadmill test and Naughton protocol to estimate oxygen consumption at 85% of predicated maximal HR muscle strength, assessed using back/leg extensor dynamometers (Takei Back‐A model #Tkk5002 ‐ i.e. best of 3 attempts) and handgrip dynamometer (Lafeyette Model No. 78010) BMI waist to hip ratio, using a nonstretching tape measure to measure the waist and hip circumferences over undergarments with 3 measurements averaged percent body fat and bone mineral density, assessed by dual energy X‐ray absorptiometry caloric intake, assessed with a 3‐day diet record (i.e. 1 weekend and 2 weekdays) and analyzed with Diet Analysis Plus software, version 7.0.1 (Thomson) perceived health, assessed using a 5‐point Likert scale
Outcomes were measured at baseline, 12 weeks, and 3 months after intervention (6 months after randomization)
exercise group: n = 21 at baseline, n = 20 at 12 weeks, n = 19 at 6 months control group: n = 20 at baseline, n = 19 at 12 weeks, n = 17 at 6 months
Adverse events: none reported |
| Notes |
Country: US
Funding: Southern Illinois University School of Medicine Excellence in Academic Medicine Award, Brooks Medical Research Fund, Memorial Medical Center Foundation and Regional Cancer Center |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Computer‐generated" |
| Allocation concealment (selection bias) |
Unclear risk |
"Sealed envelopes" |
| 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 |
The investigators stated that they conducted an ITT analyses, but 2 participants withdrew from the exercise group and 3 from the control group. The authors also reported that the rate of missing data for the FACT‐ES and the FACT‐Cog exceeded the pre‐specified amount for imputation of values and they analyzed |
| 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 |
