Foot and Ankle Exercise Program for Adults with Diabetes to Improve Health and Quality of Life in Primary Care

What this Trial Is About

Researchers are evaluating a preventive intervention for people with diabetic foot in primary care settings. This type 2 hybrid implementation effectiveness trial aims to implement a 12-week face-to-face group of foot and ankle exercises led by trained primary care workers. The study will monitor both the implementation process and clinical outcomes including clinical and functional status and quality of life. The trial is conducted in four phases pre-implementation to gather local information and form the team structuring and adapting the intervention with training strategies implementation using software or a booklet where patients perform supervised foot exercises over 12 weeks and maintenance where the local municipality supports ongoing use and expansion. During phase 3, a randomized controlled trial with 356 patients with diabetic neuropathy compares an intervention group performing supervised exercises against a control group receiving standard foot care without exercises. Participants will be evaluated at baseline and after 12 weeks for outcomes such as neuropathy symptoms, ankle and foot joint range of motion, neuropathy severity, muscle strength, ulcers, and quality of life. The study uses various assessments including the Michigan Neuropathy Screening Instrument and pressure plate measurements. Researchers will also assess implementation reach, adoption, and sustainability using the RE-AIM tool. The total study duration extends to 12 weeks of intervention and monitoring, with follow-up evaluations at key points.

FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care