Background
Methods
Subjects, recruitment strategy, and eligibility for enrolment
Design, randomized allocation, and procedures
Intervention group (n = 30) | Control group (n = 30) | p-value | |||
---|---|---|---|---|---|
n | % | n | % | ||
Age (years) | |||||
Mean (SD) | 61.3 (10.1) | 64.1 (10.9) | 0.304 | ||
Gender | |||||
Male | 14 | 46.7 | 19 | 63.3 | 0.195 |
Female | 16 | 53.3 | 11 | 36.7 | |
Weight (kg, SD) | 74.3 (14.7) | 72.7 (12.1) | 0.553 | ||
Height (cm, SD) | 171.2 (8.3) | 172.3 (7.5) | 0.906 | ||
Body mass index | |||||
Mean (SD) | 25.3 (4.5) | 24.4 (3.6) | 0.559 | ||
Karnofsky-index (median, range) | 80 (70–100) | 80 (70–100) | 1.000 | ||
Primary site | |||||
Lung cancer | 12 | 9.2 | 8 | 26.6 | 0.320 |
Breast cancer | 5 | 16.7 | 6 | 20.1 | 0.542 |
Prostate cancer | 5 | 16.7 | 9 | 30.1 | 0.156 |
Melanoma | 1 | 3.3 | 1 | 3.3 | 1.000 |
Renal cancer | 1 | 3.3 | 2 | 6.7 | 0.875 |
Other | 6 | 20.1 | 4 | 13.4 | 0.325 |
Localization metastases | 0.717 | ||||
Thoracic | 17 | 56.7 | 14 | 46.7 | |
Lumbar | 9 | 30.0 | 13 | 43.3 | |
Thoracic and lumbar | 2 | 6.7 | 2 | 6.7 | |
Sacrum | 2 | 6.7 | 1 | 3.3 | |
Number metastases | 0.257 | ||||
Mean (range) | 1.4 (2–4) | 1.7 (1–5) | |||
Solitary | 22 | 73.3 | 18 | 60.0 | |
Multiple | 8 | 26.7 | 12 | 40.0 | |
Type of metastases | 0.961 | ||||
Mixed | 2 | 6.7 | 2 | 6.7 | 1.000 |
Osteoblast | 9 | 30.0 | 10 | 33.3 | 0.956 |
Osteolytic | 19 | 63.3 | 18 | 60.0 | .0932 |
Distant metastases at baseline | |||||
Visceral | 12 | 40.0 | 5 | 16.7 | 0.045 |
Brain | 3 | 10.0 | 3 | 10.0 | 1.000 |
Lung | 7 | 23.3 | 4 | 13.3 | 0.320 |
Tissue | 8 | 26.7 | 6 | 20.0 | 0.542 |
Hormonotherapy | 10 | 33.3 | 16 | 53.3 | 0.118 |
Immunotherapy | 7 | 23.3 | 5 | 16.7 | 0.519 |
Chemotherapy | 25 | 83.3 | 20 | 66.7 | 0.136 |
Pathological fracture at baseline | 6 | 20.0 | 9 | 30.0 | 0.379 |
Neurological deficit | 0 | 0.0 | 2 | 6.7 | 0.150 |
Orthopedic corset at baseline | 7 | 23.3 | 5 | 16.7 | 0.519 |
Radiotherapy dose completed (Gy) | 0.136 | ||||
Single dose (median, range) | 3 (2–4) | 3 (2–4) | 1.000 | ||
Cumulative dose (median, range) | 30 (30–40) | 30 (30–40) | 1.000 |
Study interventions
Assessment of the primary and secondary endpoints
1. | I don’t have any trouble putting on my socks/shoes on my own. (absolutely true = 1 to absolutely false = 6) |
2. | I don’t have any trouble putting on a t-shirt on my own. (absolutely true = 1 to absolutely false = 6) |
3. | I have trouble getting up from a low chair. (absolutely true = 1 to absolutely false = 6) |
4. | I don’t have any trouble getting into a car. (absolutely true = 1 to absolutely false = 6) |
5. | The longest distance I can currently walk is approx. <100 m; 100–500 m; 500-1000 m; 1–2 km; 2–5 km; > 5 km |
6. | After covering this distance I’m thoroughly exhausted. (absolutely true = 1 to absolutely false = 6) |
7. | I’m still capable of riding a bicycle yes = 1; no = 0 |
8. | The longest riding distance I’m still capable of is approx. <2 km; 2–5 km; 5–10 km; 10–15 km; 15–20 km; >20 km |
9. | After riding this distance I’m thoroughly exhausted. (absolutely true = 1 to absolutely false = 6) |
10. | I can walk up stairs from one storey to the next with ease. (absolutely true = 1 to absolutely false = 6) |
11. | I don’t have any trouble carrying a shopping basket approx. 50 m. (absolutely true = 1 to absolutely false = 6) |
Compliance with the intervention
Radiotherapy
Sample calculation and statistical analysis
Results
Mean | SD | Min | Median | Max | |
---|---|---|---|---|---|
Previous training
| |||||
Felling sluggish (pts. 1–6) | 2.8 | 0.9 | 1.2 | 2.9 | 5.4 |
Psychological stress (pts. 1–6) | 2.6 | 0.9 | 1.2 | 2.8 | 5.1 |
After training
| |||||
Felling sluggish (pts. 1–6) | 2.2 | 0.9 | 1.1 | 2.0 | 5.0 |
Psychological stress (pts. 1–6) | 2.1 | 0.8 | 1.1 | 1.9 | 4.6 |
Teatment effect (previous vs. after) | p < .001 in both parameters | ||||
Difference T0-T2 | p < .001 in both parameters | ||||
Pain during intervention (n, %) | 5 (16.7) | ||||
Pain medication needed (n, %) | 4 (13.3) |
Chair stand test | Intervention group (n = 30) | Control group (n = 30) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
n | Mean | SD | Min | Median | Max | n | Mean | SD | Min | Median | Max | |
Baseline (t0) | 30 | 5.1 | 1.4 | 2.0 | 5.0 | 7.0 | 30 | 4.6 | 2.0 | 0.0 | 4.0 | 9.0 |
End of RT (t1) | 30 | 6.7 | 1.9 | 4.0 | 6.5 | 12.0 | 30 | 4.9 | 2.2 | 0.0 | 5.0 | 10.0 |
After 3 month (t2) | 25 | 9.0 | 2.6 | 5.0 | 10.0 | 13.0 | 23 | 5.0 | 2.7 | 0.0 | 5.0 | 10.0 |
Treatment effect within groups (t2) | p < .001 | p = 0.525 | ||||||||||
Treatment effect between groups (t2) | p < .001 | |||||||||||
pain response (VAS 0–10)
| ||||||||||||
Pain score at baseline (VAS) | 30 | 4.8 | 2.1 | 0.5 | 5.0 | 9.0 | 30 | 5.1 | 2.7 | 0.0 | 5.3 | 9.0 |
Pain score end of RT (VAS) | 30 | 2.4 | 2.0 | 0.0 | 2.0 | 8.0 | 30 | 3.3 | 2.5 | 0.0 | 3.3 | 9.0 |
Pain score after 3 month (VAS) | 25 | 1.9 | 1.4 | 0.0 | 1.5 | 5.0 | 23 | 3.8 | 2.3 | 0.0 | 4.5 | 7.0 |
Treatment effect within groups (t2) | p < .001 | p = 0.010 | ||||||||||
Treatment effect between groups (t2) | p = 0.003 | |||||||||||
No response (n, %) | 8 | 32% | 12 | 52.2% | ||||||||
Partial response (n, %) | 5 | 20% | 6 | 26.1% | ||||||||
Complete response (n, %) | 12 | 48% | 5 | 21.7% | ||||||||
Treatment effect (t2) | p = 0.158 |
Intervention group | p-value | Control group (n = 30) | p-value | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline (t0) (n = 30) | After 3 month (t2) (n = 25) | Baseline (t0) (n = 30) | After 3 month (t2) (n = 23) | |||||||||||
Q | Mean | Min | Max | Mean | Min | Max | Mean | Min | Max | Mean | Min | Max | ||
1 | 2.5 | 1.0 | 6.0 | 1.8 | 1.0 | 5.0 | 0.063 | 3.6 | 1.0 | 6.0 | 3.2 | 1.0 | 6.0 | 0.022 |
2 | 2.6 | 1.0 | 6.0 | 2.0 | 1.0 | 6.0 | 0.137 | 3.4 | 1.0 | 6.0 | 3.6 | 1.0 | 6.0 | 0.028 |
3 | 3.5 | 1.0 | 6.0 | 3.6 | 1.0 | 6.0 | 0.490 | 3.8 | 1.0 | 6.0 | 3.1 | 1.0 | 6.0 | 0.255 |
4 | 2.3 | 1.0 | 6.0 | 1.9 | 1.0 | 6.0 | 0.011 | 3.6 | 1.0 | 6.0 | 3.1 | 1.0 | 6.0 | 0.063 |
5 | 2326.7 | 100 | 5000 | 2768.0 | 100 | 5000 | 0.061 | 1430.0 | 100 | 5000 | 1882.6 | 100 | 5000 | 0.109 |
6 | 3.0 | 1.0 | 6.0 | 2.8 | 1.0 | 6.0 | 1.000 | 2.9 | 1.0 | 6.0 | 2.6 | 1.0 | 6.0 | 0.791 |
7 | 0.4 | 0.0 | 1.0 | 0.5 | 0.0 | 1.0 | 0.426 | 0.3 | 0.0 | 1.0 | 0.4 | 0.0 | 1.0 | 0.548 |
8 | 2466.7 | 0.0 | 10000 | 4400.0 | 0.0 | 15000 | 0.708 | 3000.0 | 0.0 | 20000 | 3347.8 | 0.0 | 20000 | 0.478 |
9 | 1.3 | 0.0 | 6.0 | 1.6 | 0.0 | 6.0 | 0.848 | 1.6 | 0.0 | 6.0 | 1.8 | 0.0 | 6.0 | 0.945 |
10 | 2.8 | 1.0 | 6.0 | 2.6 | 1.0 | 6.0 | 0.008 | 4.1 | 1.0 | 6.0 | 3.7 | 1.0 | 6.0 | 0.080 |
11 | 3.8 | 1.0 | 6.0 | 3.3 | 1.0 | 6.0 | 0.675 | 4.0 | 1.0 | 6.0 | 3.3 | 1.0 | 6.0 | 0.974 |