A Pilot Study of the Effectiveness of Foot-Ankle and Walking Exercises in Patients With Diabetes Mellitus

Summary

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.

Conditions

• Diabete Mellitus
• Diabete Type 2
• Diabetic Peripheral Neuropathy
• Diabetic Foot
• Diabetes
• Diabetes (DM)
• Exercise

Interventions

BEHAVIORAL

Foot-ankle exercise group

Participants in the foot-ankle exercise group received usual care provided by the PHC and an additional intervention consisting of diabetes and foot-ankle exercise education plus a printed leaflet. During the initial session, participants were instructed on the foot-ankle exercise procedures and practiced each movement under supervision to ensure correct technique. Following the initial training, participants performed the foot-ankle exercises independently for 12 weeks. One exercise session required approximately 10-15 minutes. To meet the recommended target of moderate physical activity (150 minutes per week), participants were advised to complete 2-3 sessions per day. Participants were instructed to avoid two consecutive days without performing the exercises. Participants recorded all home-based foot-ankle exercise sessions on log sheets provided at the first meeting. Intervention monitoring was conducted through regular communication via a moderated group chat.

BEHAVIORAL

Walking exercise group

Participants in the walking exercise group received usual care provided by the PHC and an additional intervention consisting of diabetes and walking-exercise education plus a printed leaflet. Participants performed walking exercises independently without supervision for 12 weeks. Participants were instructed to walk at their usual, comfortable daily pace. The physical activity target was to achieve a moderate level of physical activity totaling 150 minutes per week. To meet this target, participants were advised to complete walking sessions of at least 10 minutes per session, avoid two consecutive days without walking, and ensure a minimum cumulative duration of 150 minutes per week. Participants documented all walking-exercise sessions using log sheets provided at the first meeting. Intervention monitoring was conducted through regular communication via a moderated group chat.

OTHER

Control group

Usual care and health education Participants in the control group received the usual care provided by the community health center and intervention in the form of health education about DM in general.

Sponsors & Collaborators

• Taipei Medical University

  lead OTHER

Principal Investigators

• Siti Fadlilah · Taipei Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-05

Primary Completion

2024-09-29

Completion

2024-09-30

Countries

• Indonesia

Study Locations