Older patients' perspectives on participating in multimodal rehabilitation including anabolic steroids following hip fracture: a qualitative study embedded within a pilot RCT.

PURPOSE: To explore patient perspectives of participating in a pilot RCT evaluating feasibility and effect of anabolic steroid, physiotherapy and nutritional supplement following hip fracture. METHODS: Semi-structured telephone-based interviews of 16 women and three men (average age 73 years) were conducted at baseline and after a 12-week intervention. Qualitative content analysis was performed. RESULTS: Two main categories were identified: (1) Trust and hope for a positive change with three sub-categories; reflections on anabolic steroids, anticipation of extra attention, lack of energy. (2) Curiosity, care, and commitment with four sub-categories; a sense of anabolic steroids, feeling of exclusivity and privileges, challenges and sense of obligation, and perspectives on personal gain. CONCLUSIONS: Findings suggest high acceptability of the intervention. Participants motivated their participation on a trust that the intervention would "do more good than harm". They found the randomization and possibility of receiving anabolic steroids intriguing, and especially valued trial participation because of their experience of getting extra care and "deluxe" rehabilitation including close contact and support by health professionals. Our findings may help inform future research recruiting older patients and generally considered relevant for health professionals in rehabilitation, emphasizing the impact of professional guidance and social support to encourage self-efficacy.Implications for rehabilitationWith muscle enhancing medicine being suggested as a supplement in rehabilitation following hip fracture, exploring patients' perspectives is warranted and may help inform future trials in this area.Factors reported as important by older adults for engaging in rehabilitation trials are: simple but thorough information, friendly and trustful relation with study staff and opportunities of extra care and attention.Older patients with hip fracture highly valued professional guidance and support by health professionals during the rehabilitation intervention. High acceptability was identified for the supervised outpatient rehabilitation, where especially the individually structured progressive strength training was highlighted as the "active ingredient" accelerating recovery and potentially promoted self-efficacy.

Exercise Therapy Is Effective at Improving Short- and Long-Term Mobility, Activities of Daily Living, and Balance in Older Patients Following Hip Fracture: A Systematic Review and Meta-Analysis.

BACKGROUND: A systematic review and meta-analysis was performed to evaluate the short- and long-term effects of exercise therapy on physical function, independence, and well-being in older patients following hip fracture and, secondly, whether the effect was modified by trial-level characteristics such as intervention modality, duration, and initiation timepoint. METHOD: Medline, CENTRAL, Embase, CINAHL, and PEDro were searched up to November 2020. Eligibility criteria were randomized controlled trials investigating the effect of exercise therapy on physical function, independence, and well-being in older patients following hip fracture, initiated from time of surgery up to 1 year. RESULTS: Forty-nine studies involving 3 905 participants showed a small-to-moderate effect of exercise therapy at short term (end of intervention) on mobility (standardized mean difference [SMD] 0.49, 95% confidence interval [CI]: 0.22-0.76); activities of daily living (ADL) (SMD 0.31, 95% CI: 0.16-0.46); lower limb muscle strength (SMD 0.36, 95% CI: 0.13-0.60); and balance (SMD 0.34, 95% CI: 0.14-0.54). At long term (closest to 1 year), small-to-moderate effects were found for mobility (SMD 0.74, 95% CI: 0.15-1.34), ADL (SMD 0.42, 95% CI: 0.23-0.61), balance (SMD 0.50, 95% CI: 0.07-0.94), and health-related quality of life (SMD 0.31, 95% CI: 0.03-0.59). Certainty of evidence was evaluated using Grading of Recommendations Assessment, Development and Evaluation ranging from moderate to very low, due to study limitation and inconsistency. CONCLUSION: We found low certainty of evidence for a moderate effect of exercise therapy on mobility in older patients following hip fracture at end of treatment and follow-up. Further, low evidence was found for small-to-moderate short-term effect on ADL, lower limb muscle strength and balance. CLINICAL TRIALS REGISTRATION NUMBER: CRD42020161131.

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).

BACKGROUND: Anabolic steroid has been suggested as a supplement during hip fracture rehabilitation and a Cochrane Review recommended further trials. The aim was to determine feasibility and preliminary effect of a 12-week intervention consisting of anabolic steroid in addition to physiotherapy and nutritional supplement on knee-extension strength and function after hip fracture surgery. METHODS: Patients were randomized (1:1) during acute care to: 1. Anabolic steroid (Nandrolone Decanoate) or 2. Placebo (Saline). Both groups received identical physiotherapy (with strength training) and a nutritional supplement. Primary outcome was change in maximal isometric knee-extension strength from the week after surgery to 14 weeks. Secondary outcomes were physical performance, patient reported outcomes and body composition. RESULTS: Seven hundred seventeen patients were screened, and 23 randomised (mean age 73.4 years, 78% women). Target sample size was 48. Main limitations for inclusion were "not home-dwelling" (18%) and "cognitive dysfunction" (16%). Among eligible patients, the main reason for declining participation was "Overwhelmed and stressed by situation" (37%). Adherence to interventions was: Anabolic steroid 87%, exercise 91% and nutrition 61%. Addition of anabolic steroid showed a non-significant between-group difference in knee-extension strength in the fractured leg of 0.11 (95%CI -0.25;0.48) Nm/kg in favor of the anabolic group. Correspondingly, a non-significant between-group difference of 0.16 (95%CI -0.05;0.36) Nm/Kg was seen for the non-fractured leg. No significant between-group differences were identified for the secondary outcomes. Eighteen adverse reactions were identified (anabolic = 10, control = 8). CONCLUSIONS: Early inclusion after hip fracture surgery to this trial seemed non-feasible, primarily due to slow recruitment. Although inconclusive, positive tendencies were seen for the addition of anabolic steroid. TRIAL REGISTRATION: Clinicaltrials.gov NCT03545347 .

Knee Extension Strength Measures Indicating Probable Sarcopenia Is Associated with Health-Related Outcomes and a Strong Predictor of 1-Year Mortality in Patients Following Hip Fracture Surgery.

To examine if knee-extension strength (KES) measures indicating probable sarcopenia are associated with health-related outcomes and if KES and hand grip strength (HGS) measures are associated with 1-year mortality after hip fracture. Two groups of older patients with hip fracture had either HGS (n = 32) or KES (n = 150) assessed during their acute hospital stay. Cut-points for HGS (<27 kg for men and <16 kg for women), and cut-points for maximal isometric KES (non-fractured limb), being the lowest sex-specific quintile (<23.64 kg for men and <15.24 kg for women), were used to examine association with health-related outcomes and 1-year mortality. Overall, 1-year mortality was 12.6% in the two strength groups, of which 47% (HGS) and 46% (KES) respectively, were classified as probable sarcopenia. Probable sarcopenia patients (KES) had lower prefracture function, performed poorly in mobility measures and expressed a greater concern of falling compared to their stronger counterparts. Hazard ratio for 1-year mortality was 2.7 (95%CI = 0.49-14.7, p = 0.3) for HGS and 9.8 (95%CI = 2.2-43.0, p = 0.002) for KES for probable sarcopenia patients compared to those not. Sex-specific KES measures indicating sarcopenia is associated with health-related outcomes and a strong predictor of 1-year mortality after hip fracture.

Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial).

BACKGROUND: A 2014 Cochrane review evaluating the effect of anabolic steroids after hip fracture concluded that the quality of the studies was insufficient to draw conclusions on the effects and recommended further high-quality trials in the field. Therefore, the aim of this pilot trial is to determine the preliminary effect and feasibility of a 12-week multimodal intervention consisting of physiotherapy (with strength training), protein-rich nutritional supplement and anabolic steroid on knee-extension muscle strength and function 14 weeks after hip fracture surgery. METHODS: We plan to conduct a randomized, placebo-controlled pilot trial with 48 patients operated for acute hip fracture. The patients are randomized (1:1) to either (1) physiotherapy with protein-rich nutritional supplement plus anabolic steroid or (2) physiotherapy with protein-rich nutritional supplement plus placebo. Outcome assessments will be carried out blinded at baseline (3-10 days after surgery) and at 14 weeks after entering the trial. Primary outcome is the change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb. Secondary outcomes are physical performance test, patient-reported outcomes, and measures of body composition. DISCUSSION: If the trial is found feasible and the results show an indication of anabolic steroid being a relevant addition to further enhance the recovery of muscle strength and function in an enhanced recovery after surgery program, this trial will constitute the basis of a larger confirmatory trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03545347. Preregistered on 4 June 2018.

The Barthel Index and the Cumulated Ambulation Score are superior to the de Morton Mobility Index for the early assessment of outcome in patients with a hip fracture admitted to an acute geriatric ward.

PURPOSE: To examine clinimetric properties of the de Morton Mobility Index (DEMMI) in patients with hip fracture in comparison with the modified Barthel Index (BI), Cumulated Ambulation Score (CAS), and 30-s Chair Stand Test (30-s CST). MATERIALS AND METHODS: Two hundred and twenty two patients with a hip fracture admitted to a geriatric ward following surgery were assessed on day 1 and at discharge (mean of 9 [SD 5.1] post-surgery days). RESULTS: Ninety eight percent and 89% of patients were not able to perform the 30-s CST at baseline and at discharge (large floor effect), respectively. Corresponding floor effects were 39% and 31% for DEMMI, 12% and 5% for BI, and 22% and 6%, respectively, for CAS. Convergent validity was strong between DEMMI and CAS (r = 0.76, 95% CI: 0.69-0.81), and moderate between DEMMI and BI (r = 0.58, 95% CI: 0.48-0.66) and CAS and BI (r = 0.49, 95% CI: 0.39-0.59). Responsiveness, as indicated by the effect size was 0.76 for DEMMI, 1.78 for BI and 1.04 for CAS. Baseline scores of DEMMI, BI, and CAS showed similar properties in predicting discharge destination of patients from own home. CONCLUSIONS: The value of using DEMMI and 30-s CST in patients with hip fracture during the acute hospitalization seems limited in comparison with BI and CAS. DEMMI and CAS seem to assess similar constructs. Implications for Rehabilitation Outcome measures used for the evaluation of patients with hip fracture should be validated in the specific time-line and rehabilitation setting following surgery, before being implemented in daily clinical practice. We suggest the Cumulated Ambulation Score for monitoring basic mobility during the acute hospitalization for the entire group of patients recovering from a hip fracture, while DEMMI seems more feasible for the subgroup of patients with higher functional levels. The modified Barthel Index seems useful for the assessment of activities of daily living in the acute care setting of patients with hip fracture. We cannot recommend the original 30-s Chair Stand Test to be used for the evaluation of patients with hip fracture in the acute hospital setting.

Predictors of not regaining basic mobility after hip fracture surgery.

PURPOSE: Regaining basic mobility after hip fracture surgery is a milestone in the in-hospital rehabilitation. The aims were to investigate predictors for not regaining basic mobility at the fifth post-operative day and at discharge after undergoing hip fracture surgery. METHOD: In a prospective cohort study 274 hip fracture patients were included. Patients with compromised ability to exercise were excluded leaving 167 patients for analysis. Patient demographics, functional level, method of operation, post-operative hemoglobin and the completion of physiotherapy was registered. Basic mobility was assessed by the Cumulated Ambulation Score. Multivariate logistic regression was performed. RESULTS: Age >80 years (OR = 7.5), low prefracture functional level (OR = 3.0), not completed the physiotherapy on first post-operative day (OR = 4.6) and hemoglobin <6 mmol/L measured on first post-operative day (OR = 5.8) were significant predictors of not regaining basic mobility within the fifth post-operative day (p values: 0.04 - <0.0001). Predictors of not regaining basic mobility at discharge were: Age >80 years (OR = 4.3), prefracture functional level (OR = 7.0) and not completed the physiotherapy on first post-operative day (OR = 3.3) (p values: 0.009-<0.0001). CONCLUSIONS: This study shows that patients undergoing hip fracture surgery, who are not able to complete physiotherapy on first post-operative day, are at a greater risk of not regaining basic mobility during hospitalization. This highlights the importance of physiotherapy as part of the interdisciplinary treatment. IMPLICATIONS FOR REHABILITATION: Regaining abilities in basic mobility after hip fracture surgery is a primary goal of rehabilitation during hospitalization in the acute ward. The following factors are indentified to predict patients not regaining their previous level of basic mobility: Age >80 years, low prefracture functional level, patients not being able to complete the physiotherapy on the first post-operative day and hemoglobin value <6 mmol/l on the first post-operative day. In future strategies, the findings regarding both modifiable and unmodifiable factors, can be used to conduct early planning of discharge and to take actions in relation to patients who are at a risk of not regaining basic mobility.