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2.5. Other measures
The 400-m walk was used as a measure of cardiovascular fitness
and muscle strength was assessed using the 1-RM method
. Strength is reported as the sum of the chest press and leg press,
representative of upper- and lower-body strength, respectively. Percent
body fat was determined using dual-energy x-ray absorptiometry. PSA
and total testosterone were assessed by an accredited laboratory.
Nutritional status was assessed by the Mini Nutritional Assessment
and self-reported physical activity by the Leisure Score Index of the
Godin Leisure-Time Exercise Questionnaire
2.6. Statistical analyses and sample size calculation
The sample size estimate for the RCT was based on projected changes in
the primary outcomes of bone mineral density and cardiorespiratory
capacity To achieve 90% power at an a level of 0.05 (two-tailed) and
account for an attrition rate of up to 35%, 65 patients per group were
required. For fatigue and vitality, assuming a minimally important
difference (MID) of 5 points for fatigue and for vitality ,
69 patients per group were required for fatigue ( 51 patients for 80%
power), and 42 patients per group for vitality. Data were analysed
using IBM SPSS Version 21 (IBM Corp., Armonk, NY, USA). Analyses
included standard descriptive statistics, chi-square, one-way analysis of
variance, and one-way and two-way (group x time) repeated measures
analysis of variance. Follow-up tests were performed if the interaction or
main effect for time was significant. Where appropriate, the Bonferroni
post-hoc procedure for multiple comparisons was used to locate the
source of significant differences. Trend analysis was performed using
linear regression and entering quartiles of fatigue and vitality at baseline
as an ordinal variable. Intention to treat was utilised for all analyses
using maximum likelihood imputation of missing values (expectation
maximisation). Tests were two-tailed with an a level of 0.05 applied as
the criterion for statistical significance.
3. Results
3.1. Patients characteristics
There were no significant differences among groups at
baseline ). The median (interquartile range) time for
entry into the study since diagnosis was 8 (4–73) mo, 9 (4–
47) mo, and 8 (4–40) mo, and for time on ADT 3 (2–4) mo, 3
(2–4) mo, and 2 (2–4) mo for ILRT, ART, and DEL,
respectively. Of the 163 participants, four men had missing
data at baseline for both fatigue and vitality resulting in a
study group of 159 men in this report. Of these 159 parti-
Table 2 – Participant characteristics (mean W standard deviation)
ILRT ART DEL
(n = 57) (n = 54) (n = 48) p value
Age (y) 68.9 9.1 69.0 9.3 68.4 9.1 0.947
Height (cm) 173.6 5.8 173.2 6.8 171.6 5.2 0.215
Weight (kg) 84.4 11.2 84.9 15.6 88.4 15.4 0.316
Body fat (%) 28.1 4.8 27.3 5.9 29.6 5.0 0.086
Gleason score 7.7 1.4 8.0 0.9 7.8 1.0 0.548
Cancer stage grouping
Localised, N (%) 52 (91.2) 50 (92.6) 45 (93.8) 0.887
Nodal metastases, N (%) 5 (8.8) 4 (7.4) 3 (6.3)
Bone metastases, N (%) 0 (0) 0 (0) 0 (0)
PSA (ng/ml) 1.3 2.1 1.0 1.8 1.3 2.4 0.730
Testosterone (pg/ml) 0.8 1.1 1.1 2.6 1.3 3.4 0.536
MNA 27.2 2.3 27.6 2.2 27.6 1.8 0.633
Godin LSI 20.6 16.5 23.5 20.7 21.8 16.0 0.698
Employed, N (%) 22 (38.6) 17 (31.5) 19 (39.6) 0.571
Married, N (%) 44 (77.2) 42 (77.8) 43 (89.6) 0.720
Current smoker, N (%) 3 (5.3) 3 (5.6) 3 (6.3) 0.822
ADT + antiandrogen, N (%) 27 (47.4) 30 (55.6) 27 (56.3) 0.586
ADT time (mo) 4.2 4.5 5.3 7.6 3.7 3.7 0.320
Radiation, N (%) 49 (86.0) 50 (92.6) 40 (83.8) 0.341
Prostatectomy, N (%) 20 (35.1) 15 (27.8) 12 (25.0) 0.497
Other conditions
CVD, N (%) 4 (7.0) 3 (5.6) 2 (4.2) 0.819
Hypertension, N (%) 20 (35.1) 15 (27.8) 23 (47.9) 0.104
Dyslipidaemia, N (%) 11 (19.3) 14 (25.9) 10 (20.8) 0.682
Diabetes, N (%) 5 (8.8) 7 (13.0) 8 (16.7) 0.475
ADT = androgen deprivation therapy; ART = aerobic + resistance training; DEL = usual care/delayed exercise; ILRT = impact-loading + resistance training;
LSI = Leisure Score Index; PSA = prostate specific antigen; MNA = Mini Nutritional Assessment with malnourished <17, undernourished 17–23.5, well-
nourished >23.5; Godin LSI, with a moderate-to-strenuous LSI 24 classed as active and 23 classed as insufficiently active.
Table 1 – Fatigue subscale questions from the European
Organisation for Research and Treatment of Cancer Quality of Life
Questionnaire-Core 36 and the Vitality scale questions from the
Short Form-36 Health Survey
Fatigue subscale questions
During the past wk (4-point scale from ‘‘Not At All’’ to ‘‘Very Much’’):
Did you need to rest?
Have you felt weak?
Were you tired?
Vitality scale questions
How much of the time during the past 4 wk (5-point scale from
‘‘All of the Time’’ to ‘‘None of the Time’’):
Did you feel full of life?
Did you have a lot of energy?
Did you feel worn out?
Did you feel tired?
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