Effect of Individual Nutrition Therapy and Exercise Regime on Gait Speed, Physical Function, Strength and Balance, Body Composition, Energy and Protein, in Injured, Vulnerable Elderly: A Multisite Randomized Controlled Trial (INTERACTIVE).

It is imperative that the surgical treatment of hip fractures is followed up with rehabilitation to enhance recovery and quality of life. This randomized controlled trial aimed to determine if an individualised, combined exercise-nutrition intervention significantly improved health outcomes in older adults, after proximal femoral fracture. We commenced the community extended therapy while in hospital, within two weeks post-surgery. The primary outcome was gait speed and secondary outcomes included physical function, strength and balance, body composition, energy and protein intake. Eighty-six and 89 participants were randomized into six months individualised exercise and nutrition intervention and attention-control groups, respectively. There were no statistically significant differences in gait speed between the groups at six and 12 months. There were no major differences between groups with respect to the secondary outcomes, except estimated energy and protein intake. This may be explained by the sample size achieved. Participants in the intervention group had greater increment in energy (235 kcal; 95% CI, 95 to 375; p = 0.01) and protein intake (9.1 g; 95% CI, 1.5 to 16.8; p = 0.02), compared with those in the control group at six months but not significant at 12 months. This study has demonstrated that providing early, combined exercise and nutrition therapy can improve dietary energy and protein intake in older adults with hip fractures.

Cost-effectiveness of individualized nutrition and exercise therapy for rehabilitation following hip fracture.

OBJECTIVE: To undertake a cost-utility analysis of the Individual Nutrition Therapy and Exercise Regime: A Controlled Trial of Injured, Vulnerable Elderly (INTERACTIVE) trial. DESIGN: Cost-utility analysis of a randomized controlled trial. SUBJECTS: A total of 175 patients following a hip fracture were allocated to receive either alternate weekly visits from a physical therapist and dietitian (intervention group), or social visits for 6 months (control group). METHODS: Costs for utilization of hospitals, health and community services were compared with quality-adjusted life years gained, calculated from responses to the Assessment of Quality of Life instrument. RESULTS: There were minimal differences in mean costs between the intervention ($AUD 45,331 standard deviation (SD): $AUD 23,012) and the control group ($AUD 44,764 SD: $AUD 20,712, p = 0.868), but a slightly higher mean gain in quality-adjusted life years in the intervention group (0.155, SD: 0.132) compared with the control group (0.139, SD: 0.149, p = 0.470). The incremental cost-effectiveness ratio was $AUD 28,350 per quality-adjusted life year gained, which is below the implied cost-effectiveness threshold utilized by regulatory authorities in Australia. CONCLUSION: A comprehensive 6-month programme of therapy from dietitians and physical therapists could be provided at a relatively low additional cost in this group of frail older adults, and the incremental cost-effectiveness ratio indicates likely cost-effectiveness, although there was a very high level of uncertainty in the findings.

Individual nutrition therapy and exercise regime: a controlled trial of injured, vulnerable elderly (INTERACTIVE trial).

BACKGROUND: Proximal femoral fractures are amongst the most devastating consequences of osteoporosis and injurious accidental falls with 25-35% of patients dying in the first year post-fracture. Effective rehabilitation strategies are evolving however, despite established associations between nutrition, mobility, strength and strength-related functional outcomes; there has been only one small study with older adults immediately following fragility fracture where a combination of both exercise and nutrition have been provided. The aim of the INTERACTIVE trial is to establish whether a six month, individualised exercise and nutrition program commencing within fourteen days of surgery for proximal femur fracture, results in clinically and statistically significant improvements in physical function, body composition and quality of life at an acceptable level of cost and resource use and without increasing the burden of caregivers. METHODS AND DESIGN: This randomised controlled trial will be performed across two sites, a 500 bed acute hospital in Adelaide, South Australia and a 250 bed acute hospital in Sydney, New South Wales. Four hundred and sixty community-dwelling older adults aged > 70 will be recruited after suffering a proximal femoral fracture and followed into the community over a 12-month period. Participants allocated to the intervention group will receive a six month individualised care plan combining resistance training and nutrition therapy commencing within 14 days post-surgery. Outcomes will be assessed by an individual masked to treatment allocation at six and 12 months. To determine differences between the groups at the primary end-point (six months), ANCOVA or logistic regression will be used with models adjusted according to potential confounders. DISCUSSION: The INTERACTIVE trial is among the first to combine nutrition and exercise therapy as an early intervention to address the serious consequence of rapid deconditioning and weight loss and subsequent ability to regain pre-morbid function in older patients post proximal femoral fracture. The results of this trial will guide the development of more effective rehabilitation programs, which may ultimately lead to reduced health care costs, and improvements in mobility, independence and quality of life for proximal femoral fracture sufferers. TRIAL REGISTRATION: Australian Clinical Trials Registry: ACTRN12607000017426.