This pilot feasibility and exploratory study, conducted to prepare for a definitive Randomized Controlled Trial (RCT), compares a structured foot-ankle exercise program with a walking exercise program in adults with Diabetes Mellitus (DM). The primary aim is to assess feasibility, including recruitment rate, retention, adherence, data completeness, acceptability, and adverse events, to inform procedures for the definitive RCT. The secondary (exploratory) aim is to obtain preliminary estimates of effects on Diabetic Peripheral Neuropathy (DPN), stress, and obstacles to Diabetes-Related Quality of Life (DR-QoL), Fasting Blood Glucose (FBG), Body Mass Index (BMI), blood pressure, and Ankle-Brachial Index (ABI). Participants were allocated to three parallel arms for 12 weeks: 1. Foot-ankle exercise (education plus printed materials; independent practice 2-3 sessions/day), 2. Walking exercise (education plus printed materials; ≥150 minutes/week, ≥10 minutes/session, avoiding two consecutive non-exercise days), or 3. Active control (education and printed materials). Outcomes were assessed at baseline (day 0), week 6, and week 12. Analyses focus on feasibility metrics against pre-specified progression criteria and on hypothesis-generating estimates of within- and between-group change in neuropathy, stress, and obstacles to DR-QoL; the study is not powered for definitive efficacy. Retrospective registration note: This study was registered retrospectively after participant enrolment had begun and data collection had been completed. This retrospective status is disclosed for transparency; exploratory outcome analyses are interpreted accordingly, and adverse events related to exercise were monitored and reported.
Age range
20 Years – 70 Years
Sex
ALL
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Feasibility: Recruitment Rate
Timeframe: From July 5, 2024 (first participant enrollment) to September 29, 2024 (final primary outcome data collection), over an actual period of approximately 12 weeks.
Feasibility: Retention Rate
Timeframe: From July 5, 2024 (Baseline assessment) to September 29, 2024 (Week 12 follow-up), over an actual period of approximately 12 weeks.
Feasibility: Adherence to Assigned Intervention
Timeframe: From July 5, 2024 (Week 0, baseline) to September 29, 2024 (Week 12 assessment), covering an actual intervention period of approximately 12 weeks.
Feasibility: Data Completeness
Timeframe: From July 5, 2024 (Baseline) to September 29, 2024 (Week 12 follow-up), covering the period in which data completeness at Week 6 and Week 12 was assessed (12 weeks).
Feasibility: Safety (Adverse Events)
Timeframe: From July 5, 2024 (start of intervention at Week 0) to September 29, 2024 (Week 12 follow-up), covering an actual 12-week period of adverse event monitoring.
Feasibility: Acceptability of the Intervention (Open-Ended Participant Feedback)
Timeframe: From July 5, 2024 (start of intervention) to September 29, 2024 (Week 12), when acceptability feedback was collected, covering an actual period of approximately 12 weeks.