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 (HIPSAP1 trial).
Hip fracture results in large strength deficits, causing loss of function, disability and further falls. As such, a hipfracture often leads to the loss of independence, more fractures and high mortality rates, and constitutes a substantial economic burden to the health care system. Although positive effects on mobility of structured exercise interventions including strength training are reported, these interventions alone are insufficient to overcome the major long-term negative impact of a hip fracture on physical function. Thus, it has been argued to investigate the effect of multimodal interventions including muscle-enhancing medicine.
A Cochrane Review (2014) evaluated the effect of anabolic steroids in rehabilitation following hip fracture surgery on functional outcome and adverse events. Positive tendencies were identified, but further trials were suggested.
The aim of this randomized, blinded, single-center, placebo-controlled, two-armed, parallel-group, superiority pilot trial was to investigate the feasibility and preliminary effect of a 12-week intervention consisting of anabolic steroid in addition to physiotherapy and protein-rich nutritional supplement on knee extension strength and function at 14-weeks follow-up after hip fracture surgery.
Included patients were aged 60 or above, pre-fracture home-dwelling, with indoor walking ability and without cognitive dysfunction. They were randomized (1:1) to one of two arms: anabolic steroid (INT) or placebo (CON). Both groups followed identical physiotherapy and nutritional supplement programs.
Patients in active arm (INT) received intramuscular injections of nandrolone decanoate every 3 weeks. First injection was administered at baseline and last injection at week 12. Women received 50 mg; men with total testosterone ≥11 nmol/l received 100 mg, and men with total testosterone < 11 nmol/l received a dose of 200 mg.
Following the same intervals as for the active agent, patients in placebo arm (CON) received a placebo injection of 1 ml of Sodium Chloride (9 mg/ml).
The protein-rich nutritional supplement was a liquid containing 18 g of milk-based protein per bottle. Patients received 2 bottles per day for 12 weeks.
Physiotherapy included functional exercises such as transfers and walking, as well as exercise therapy primarily aimed at lower extremities. The patients received physiotherapy 1 h twice a week, up to and including the 12th week after inclusion in the trial.
Primary outcome was the change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb from baseline to 14-week follow-up, which was measured using a belt fixated handheld dynamometer.
Secondary outcomes included performance measures, patient reported outcomes (PROM’s), measures of body composition, hormone levels and lipid profile.
The trial aimed at recruiting 48 patients. The inclusion period was extended, but eventually the trial was prematurely discontinued due to slow recruitment.
Only 23 patients were recruited;12 patients were allocated to INT and 11 to CON. One patient in each group dropped out during trial, leaving 21 patients to analyze. Mean age of the participants was 73.4 (range 62–85) years and 78% were women. Participants in general had a high pre-fracture functional level and 91% were discharged home after median 8 days hospitalization. No important differences were identified between INTand CON at baseline.
Six out of the 21 participants did not receive all 5 injections of the trial solutions; 5 where in the INT and 1 inthe CON. The adherence to injections was 87%. The adherence to the physiotherapy was 91%, with an average of 21.3 exercise sessions offered for the participants. Average consumption of nutritional supplement was 61%, with no significant difference between groups.
Knee-extension strength of the fractured and non-fractured leg improved significantly in both groups from baseline to 14-week follow-up. Between-group difference of the fractured leg was insignificant at 0.11 Nm/kg (95%Cl: -0.25; 0.48) in favor of the INT. The median percentage change in knee-extension strength of fractured leg was 178% (41–263) for INT and 50% (20–173) for CON (p = 0.28). Correspondingly, a non-significant between-group difference of 0.16 Nm/Kg (95%CI: -0.05;0.36) was seen for the non-fractured leg.
No significant between-group differences were identified for any of the secondary performance measures or patient reported outcomes.
This is the first trial investigating the feasibility and preliminary effect of anabolic steroid in addition to physiotherapy and protein-rich nutritional supplement in rehabilitation following hip fracture surgery. Although inconclusive due to the small sample size, promising tendencies were seen for the addition of anabolic steroid.
Hulsbæk S et al. (2021) Feasibility and preliminary effect of anabolic steroids in addition to strengthtraining and nutritional supplement in rehabilitation of patients with hip fracture: a randomized controlled pilot trial (HIPSAP1 trial). BMC Geriatrics 21:323.
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