Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus

Abstract

Background Type 2 diabetes, a highly prevalent chronic disease, is associated with increasing frailty and functional decline in older people. We aimed to evaluate the effectiveness of a multimodal intervention on functional performance in frail and pre‐frail participants aged ≥70 years with type 2 diabetes mellitus. Methods The MID‐Frail study was a cluster‐randomized multicenter clinical trial conducted in 74 trial sites across seven European countries. The trial recruited 964 participants who were aged >70 years [mean age in intervention group, 78.4 (SD 5.6) years, 49.2% male and 77.6 (SD 5.29) years, 52.4% male in usual care group], with type diabetes mellitus and determined to be frail or pre‐frail using Fried's frailty phenotype. Participants were allocated by trial site to follow either usual care (UCG) or intervention procedures (IG). Intervention group participants received a multimodal intervention composed of (i) an individualized and progressive resistance exercise programme for 16 weeks; (ii) a structured diabetes and nutritional educational programme over seven sessions; and (iii) Investigator‐linked training to ensure optimal diabetes care. Short Physical Performance Battery (SPPB) scores were used to assess change in functional performance at 12 months between the groups. An analysis of the cost‐effectiveness of the intervention was undertaken using the incremental cost‐effectiveness ratio (ICER). Secondary outcomes included mortality, hospitalization, institutionalization, quality of life, burden on caregivers, the frequency and severity of hypoglycaemia episodes, and the cost‐effectiveness of the intervention. Results After 12 months, IG participants had mean SPPB scores 0.85 points higher than those in the UCG (95% CI, 0.44 to 1.26, P < 0.0001). Dropouts were higher in frail participants and in the intervention group, but significant differences in SPPB between treatment groups remained consistent after sensitivity analysis. Estimates suggest a mean saving following intervention of 428.02 EUR (2016) per patient per year, with ICER analysis indicating a consistent benefit of the described health care intervention over usual care. No statistically significant differences between groups were detected in any of the other secondary outcomes. Conclusions We have demonstrated that a 12 month structured multimodal intervention programme across several clinical settings in different European countries leads to a clinically relevant and cost‐effective improvement in the functional status of older frail and pre‐frail participants with type 2 diabetes mellitus.

Applications of physical performance measures to routine diabetes care for frailty prevention concept: fundamental data with grip strength, gait speed, timed chair stand speed, standing balance, and knee extension strength

“…6-13 18 27 43-45 Usual walking speed, timed chair stand speed, grip strength, and standing balance inclusive of scoring SPPB are likely to be useful not only for evaluating the cross-sectional status but also for promoting physical activity intervention by monitoring the changes in the levels. [43][44][45][46] Most of the studies dealing with physical performance measures examined individuals without diabetes, and only a few studies were done involving patients with diabetes. 13 45 These measures must be incorporated into daily practice for patients with diabetes.…”

Identification of a Circulating Amino Acid Signature in Frail Older Persons with Type 2 Diabetes Mellitus: Results from the Metabofrail Study

“…MetaboFrail was developed as an ancillary study of the "Multi-modal Intervention in Diabetes in Frailty" (MID-Frail) project [16,33,34]. The latter was a cluster-randomized multicenter clinical trial that evaluated the effectiveness of a multicomponent intervention (mainly based on resistance exercise and lifestyle counseling) on improving physical performance compared with usual care in F-T2DM older adults from seven European countries (ClinicalTrials.gov identifier: NCT01654341) [16,33].…”

Screening for and Managing the Person with Frailty in Primary Care: ICFSR Consensus Guidelines

“…A recent meta-analysis of 31 studies including 4794 participants concluded that resistance exercise, with or without nutrition supplementation may improve the frailty status of older adults in primary care settings. In older subjects with diabetes and frailty, resistance exercise as part of a multimodal approach significantly improved physical performance over one year measured by the short performance physical battery (SPPB) which was accompanied by a significant decrease in healthcare expenditure ( 59 ). Comprehensive Geriatric Assessment was also more effective than control groups at reducing frailty ( 58 ).…”