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Table 2 Analysis of primary outcome, knee-extension strength (n = 21)

From: Feasibility and preliminary effect of anabolic steroids in addition to strength training and nutritional supplement in rehabilitation of patients with hip fracture: a randomized controlled pilot trial (HIP-SAP1 trial)

Primary outcome

Baseline

Mean (SD)

Follow-up

Mean (SD)

Within-group difference

Mean (95% CI)

Between-group difference Mean (95% CI)

Modified intention-to-treat

 

INT

(n = 11)

CON

(n = 10)

INT

(n = 11)

CON

(n = 10)

INT

(n = 11)

CON

(n = 10)

 

 Strength, Fractured (Nm/kg)

0.56 (0.38)

0.72 (0.36)

1.17 (0.46)

1.23 (0.39)

0.61 (0.34;0.88)

0.50 (0.21;0.79)

0.11 (− 0.25; 0.48)

 Strength, non-fractured (Nm/kg)

1.07 (0.45)

1.27 (0.26)

1.35 (0.39)

1.40 (0.39)

0.28 (0.20;0.37)

0.13

(− 0.07;0.32)

0.16 (− 0.05; 0.36)

 Strength, fractured % non-fractured (%)

50.5 (21.6)

59.4 (31.0)

84.6 (15.4)

89.1 (16.2)

34.1 (16.5;51.6)

29.7

(9.0;50.3)

4.4 (−20.7; 29.5)

Per protocol

Exercisea

(n = 8)

(n = 10)

(n = 8)

(n = 10)

(n = 8)

(n = 10)

 

 Strength, Fractured (Nm/kg)

0.62 (0.42)

0.73 (0.37)

1.35 (0.40)

1.23 (0.39)

0.72 (0.42;1.03)

0.50 (0.21;0.79)

0.23 (−0.16; 0.61)

 Strength, non-fractured (Nm/kg)

1.15 (0.50)

1.27 (0.26)

1.45 (0.40)

1.40 (0.39)

0.29 (0.19;0.40)

0.13 (− 0.07;0.32)

0.17 (− 0.04; 0.37)

Injections

(n = 7)

(n = 9)

(n = 7)

(n = 9)

(n = 7)

(n = 9)

 

 Strength, Fractured (Nm/kg)

0.36 (0.17)

0.69 (0.37)

1.14 (0.45)

1.25 (0.40)

0.78 (0.47;1.09)

0.56 (0.26;0.85)

0.22 (−0.17;0.61)

 Strength, non-fractured (Nm/kg)

1.00 (0.48)

1.29 (0.26)

1.33 (0.39)

1.39 (0.41)

0.33 (0.23;0.42)

0.10

(−0.11;0.31)

0.22 (0.01;0.44)*

Exercise + injections

(n = 5)

(n = 9)

(n = 5)

(n = 9)

(n = 5)

(n = 9)

 

 Strength, Fractured (Nm/kg)

0.38 (0.17)

0.69 (0.37)

1.27 (0.48)

1.25 (0.40)

0.89 (0.49;1.29)

0.56 (0.26;0.85)

0.34 (−0.10;0.77)

 Strength, non-fractured (Nm/kg)

1.05 (0.57)

1.29 (0.26)

1.36 (0.47)

1.39 (0.41)

0.32 (0.18;0.46)

0.10 (−0.11;0.31)

0.22 (−0.07;0.50)

  1. Cases removed if adherence below 75% for exercise (pre-defined) and 80% for injections (pre-defined as 100% but changed to 80% as this was reached by only one missing injection)
  2. INT intervention (anabolic group), CON control group
  3. a 3 participants non adherent to exercise due to Covid-19 lock-down
  4. * P = 0.046 (Sattertwaite due to unequal variance)