An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesize that a multimodal treatment approach incorporating various footwear, self-management, and education interventions that matches an individual person's needs can reduce the risk of ulcer recurrence with beneficial cost-utility. The aim of this study is to assess the effect on foot ulcer recurrence, footwear adherence, and cost-utility of an integrated personalized assistive devices approach in high-risk people with diabetes. METHODS: In a parallel-group multicenter randomized controlled trial, 126 adult participants with diabetes mellitus type 1 or 2, loss of protective sensation based on the presence of peripheral neuropathy, a healed plantar foot ulcer in the preceding 4 years, and possession of any type of custom-made footwear will be included. Participants will be randomly assigned to either enhanced therapy or usual care. Enhanced therapy consists of usual care and additionally a personalized treatment approach including pressure-optimized custom-made footwear, pressure-optimized custom-made footwear for indoor use, at-home daily foot temperature monitoring, and structured education, which includes motivational interviewing and personalized feedback on adherence and self-care. Participants will be followed for 12 months. Assessments include barefoot and in-shoe plantar pressure measurements; questionnaires concerning quality of life, costs, disease, and self-care knowledge; physical activity and footwear use monitoring; and clinical monitoring for foot ulcer outcomes. The study is powered for 3 primary outcomes: foot ulcer recurrence, footwear adherence, and cost-utility, the primary clinical, patient-related, and health-economic outcome respectively. DISCUSSION: This is the first study to integrate multiple interventions for ulcer prevention into a personalized state-of-the-art treatment approach and assess their combined efficacy in a randomized controlled trial in people with diabetes at high ulcer risk. Proven effectiveness, usability, and cost-utility will facilitate implementation in healthcare, improve the quality of life of high-risk people with diabetes, and reduce treatment costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.

Determinants of maximal exercise performance in chronic heart failure.

BACKGROUND: Chronic heart failure (CHF) is characterized by symptoms like fatigue, dyspnoea and limited exercise performance. It has been postulated that maximal exercise performance (Wmax) is predominantly limited by skeletal muscle function and less by heart function. AIM: To study the interrelation between most relevant muscle and anthropometrical variables and Wmax in CHF patients in order to develop a model that describes the impact of these variables for maximal exercise performance. DESIGN: In 77 patients with CHF Wmax was assessed by incremental cycle ergometry until exhaustion (20 Watt/3 min). Peak torque (strength) and total work (endurance) for the quadriceps and hamstrings were assessed by isokinetic dynamometry. Isometric strength was measured by hand dynamometry. Relevant muscle areas were calculated by computerized tomography scan. RESULTS: Significant correlations between Wmax and isokinetic muscle parameters (peak torque and total work) ranged from 0.41-0.65 (P<0.01). Other significant relationships (P<0.01) with Wmax were obtained for age (r=-0.22), gender (r=0.45), fat free mass (FFM) (r=0.51), quadriceps muscle area (r=0.73), hamstrings muscle area (r=0.50), upper leg muscle function (i.e., a combination of muscle strength and muscle endurance) (r=0.71) and isometric strength (r=0.63). Multiple regression analysis showed that upper leg muscle function and quadriceps muscle area could predict 57% of the variance in Wmax. CONCLUSION: Muscle strength and muscle endurance, combined with quadriceps muscle area are the main predictors of maximal exercise performance in patients with CHF.