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

NCT07270328 | Completed DMC

• 1 other identifier: PilotStudyRCT024_Siti Fadlilah
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

Brief 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. 1.Foot-ankle exercise (education plus printed materials; independent practice 2-3 sessions/day),
2. 2.Walking exercise (education plus printed materials; ≥150 minutes/week, ≥10 minutes/session, avoiding two consecutive non-exercise days), or
3. 3.Active control (education and printed materials).

Conditions

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

Keywords

Diabetic Peripheral Neuropathy; Stress; Quality of life; Fasting blood glucose; Body mass index; Blood pressure; Ankle-brachial index; Diabetes mellitus; Exercise; Waliking exercise; Foot-ankle exercise

Outcome Measures

Primary Outcomes (6)

• Feasibility: Recruitment Rate

  Participants enrolled per month per site and overall; eligibility and consent proportions

  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

  Proportion of enrolled participants who complete follow-up assessments at Week 6 and Week 12.

  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

  Percentage of prescribed sessions achieved (foot-ankle and walking exercise) with ≥150 min/week and "no two consecutive non-exercise days"; proportion meeting adherence threshold (≥70%) across ≥12 weeks

  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

  Proportion of participants with complete outcome data at Week 6 and Week 12 (per arm and overall).

  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)

  Exercise-related adverse events/serious adverse events (number and percentage)

  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)

  Open-ended questions elicit participants' messages/impressions, barriers, and difficulties during the intervention. Responses will be analysed with rapid thematic analysis using a pre-defined codebook; two independent coders will code all transcripts/notes, discrepancies resolved by discussion

  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.

Secondary Outcomes (7)

• Diabetic Peripeheral Neuropathy (DPN)

  From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which DPN was assessed at Baseline, Week 6, and Week 12; covering an actual 12-week period.

• Stress

  From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which stress was assessed at Baseline, Week 6, and Week 12 over an actual 12-week period.

• Obstacles to Diabetes Related Quality of Life (DR-QoL)

  From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which DR-QoL (DOQ-30) was assessed at Baseline, Week 6, and Week 12 over an actual 12-week period.

• Fasting Blood Glucose (FBG)

  From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which fasting blood glucose was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.

• Blood Pressure

  From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which blood pressure was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.

Study Arms (3)

Foot-ankle exercise group

EXPERIMENTAL

The group received intervention through health education, simulations and leaflets about footankle exercise and practised independently for 12 weeks

Behavioral: Foot-ankle exercise group

Walking exercise group

EXPERIMENTAL

The group received intervention through health education, and leaflets about walking exercise and practised independently for 12 weeks

Behavioral: Walking exercise group

Control Group

ACTIVE COMPARATOR

The group that received intervention in the form of health education and leaflets about DM in general

Other: Control group

Interventions

Foot-ankle exercise group BEHAVIORAL

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.

Foot-ankle exercise group

Walking exercise group BEHAVIORAL

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.

Walking exercise group

Control group OTHER

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.

Control Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with type 2 diabetes
• Aged 20-70 years
• Diagnosed with DM for at least 1 year
• Can walk without assistance
• Able to communicate well
• Can read and write
• Willing to be a respondent

You may not qualify if:

• Has a history of leg amputation
• Have a diagnosis of heart failure, kidney failure, pulmonary TB, stroke
• Patients with a history or under-treatment of mental disorders
• DM patients with foot ulcers
• DM patients with fractures or difficulty using the lower extremities

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (3)

Puskesmas Ngaglik 1

Sleman, Special Region of Yogyakarta, Indonesia

Location

Puskesmas Ngemplak 1

Sleman, Special Region of Yogyakarta, Indonesia

Location

Puskesmas Ngemplak 2

Sleman, Special Region of Yogyakarta, Indonesia

Location

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Related Links

• International Diabetes Federation, I. (2021). IDF Diabetes Atlas 10th edition. Available IPD/Information:

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetic Foot; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Siti Fadlilah

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors who assess the outcomes and statistician who analyse the data are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three arms parallel group design with 2 group interventions (foot-ankle exercise and walking exercise) and 1 control group

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: July 5, 2024
• Primary Completion: September 29, 2024
• Study Completion: September 30, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 60 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, for example, for a meta-analysis or other study.

Locations

ID (3)