Table 2.
GRADE Summary of Finding Table. Supervised exercise therapy compared to no exercise therapy for patients with prostate cancer receiving androgen deprivation therapy. Population: Patients with prostate cancer receiving androgen deprivation therapy. Intervention: Supervised exercise therapy. Comparison: No exercise therapy.
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
|---|---|---|---|---|---|---|
| Risk with No exercise | Risk with supervised exercise | |||||
| Diagnose-specific quality of life (critical outcome) | – | SMD 0.43 higher (0.29 higher to 0.58 higher) | – | 894 (12 RCTs) | ⨁⨁⨁◯ MODERATEa | Supervised exercise therapy probably increases diagnose-specific quality of life. |
| Health related quality of life (important outcome) assessed with: SF-36, physical component Scale from: 0 to 100 | The mean health related quality of life was 44.8 | MD 1.34 higher (1.99 lower to 4.67 higher) | – | 246 (4 RCTs) | ⨁⨁⨁◯ MODERATEa | Supervised exercise therapy probably results in little to no difference in health related quality of life, SF-36, physical component. |
| Health related quality of life (important outcome) assessed with: SF-36, mental component | The mean health related quality of life was 49.2 | MD 3.30 higher (0.87 higher to 5.74 higher) | – | 198 (3 RCTs) | ⨁⨁⨁◯ MODERATEa | Supervised exercise therapy probably results in little to no difference in health related quality of life, SF-36 mental component. |
| Physical performance, walking performance (critical outcome) | – | SMD 0.41 lower (0.60 lower to 0.22 lower) | – | 667 (11 RCTs) | ⨁⨁⨁◯ MODERATEb | Supervised exercise therapy probably improves physical performance, walking performance. |
| Physical performance, sit to stand (important outcome) | – | SMD 0.35 higher (0.14 higher to 0.56 higher) | – | 463 (8 RCTs) | ⨁⨁◯◯ LOWb,c | Supervised exercise therapy may result in an improvement in physical performance, sit to stand. |
| Muscle strenght (important outcome) | – | SMD 0.47 higher** (0.28 higher to 0.65 higher) | – | 968 (15 RCTs) | ⨁⨁⨁◯ MODERATEb | Supervised exercise therapy probably increases muscle strength. |
| VO2 peak (important outcome) | The mean VO2 peak was 0 | MD 1.76 higher (0.82 higher to 2.69 higher) | – | 406 (6 RCTs) | ⨁⨁⨁◯ MODERATEb | Supervised exercise therapy probably increases VO2 peak. |
| Prevalence of depression (important outcome) assessed with: Depressive symptoms | – | SMD 0.23 lower (0.54 lower to 0.08 higher) | – | 195 (3 RCTs) | ⨁◯◯◯ VERY LOWa,d,e | The evidence is very uncertain about the effect of supervised exercise on depression. |
| Fractures, number of patients (important outcome) | 2 per 1.000 | 1 more per 1.000*** (14 fewer to 16 more) | RR 1.86 (0.25 to 13.99) | 1131 (17 RCTs) | ⨁⨁◯◯ LOWc,f | The evidence is very uncertain about the effect of supervised exercise therapy on fractures. |
| Exercise related injuries), number of patients, risk ratio analysis (important outcome) | 0 per 1.000 | 9 more per 1.000*** (9 fewer to 28 more) | RR 5.86 (1.55 to 22.06) | 940 (15 RCTs) | ⨁⨁⨁◯ MODERATEc | Supervised exercise probably increases exercise related injuries slightly. |
| Dropout all causes, risk ratio analysis | 150 per 1.000 | 40 fewer per 1.000 (67 fewer to 0) | RR 0.73 (0.54 to 0.96) | 1487 (16 RCTs) | ⨁⨁⨁◯ MODERATEc,g | Supervised exercise probably results in little to no difference in dropout all causes |
CI: confidence interval, GRADE: Grades of Recommendation, Assessment Development and Evaluation, SMD: standardised mean difference, MD: mean difference, RR: risk ratio
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
**A subgroup analysis was performed to explain moderate heterogeneity (I2 48%). Dividing the trials in to type of exercises (aerobic, resistance, combined and football) did not reveal significant subgroup effects (P value 0.11) but reduced the heterogeneity to 0–1% among trials of combined exercise and football training. Among resistance trials the heterogeneity was substantial (I2 69%). This was explained by the intensity of the resistance exercise. By excluding two high intensity trials the heterogeneity was reduced to 0% both in the subgroup analysis and the total analysis. Since the heterogeneity could be explained, we did not downgrade for inconsistency.
In a subgroup analysis including only resistance trials and dividing the trials into high and moderate intensity, we found a significant (subgroup effect p = 0.0004). The results for trials with moderate intensity was a SMD of 0.41 (95% CI: 0.19, 0.63) and for the high intensity trials the SMD was 1.44 (95% CI: 0.72, 0.63).
***The absolute numbers are calculated based on a risk difference analysis.
Abbreviation: CI Confidence interval, GRADE Grades of Recommendation, Assessment, Development and Evaluation, SMD Standardised mean difference, MD Mean difference, RR Risk ratio.
GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.
aLack of blinding of personnel and participants and self-reported outcome.
bLack of blinding of personnel and participants, lack of blinding in the outcome assessment.
cWide CIs, CIs is overlapping the minimal clinical important difference.
dDifference between relevant and reported outcomes, our outcome of interest was prevalence of depression, the trials measure depressive symptoms.
eFew patients included in the trials (<100).
fFew events.
gWide confidence interval, but the interval is not inaccurate in relation to a recommendation. The result does not indicate the supervised exercise therapy leads to increase in dropouts.