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

NCT ID: NCT07270328

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-05
• Study Completion Date: 2024-09-30

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. 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.

Detailed Description

Intervention Description Foot-Ankle Exercise Intervention The intervention is adapted from prior research and from exercises developed by the Indonesian Endocrinology Association. Participants receive brief DM and foot-ankle education, a leaflet, and supervised simulation to ensure correct technique. Independent practice is performed 2-3 sessions/day for 12 weeks. Target exercises ≥150 minutes/week.

The structured foot-ankle exercise program consists of 10 seated movements involving toe flexion, heel raises, circular ankle motions, knee extension with toe mobility, synchronized bilateral movements, and functional foot tasks (e.g., manipulating newspaper sheets).

Walking Exercise Intervention The walking program adapts protocols from previous studies. Participants receive DM and walking-exercise education plus a leaflet. They walk independently for ≥150 minutes per week (≥10 minutes/session) while avoiding two consecutive non-exercise days during the 12-week period.

Active Control Participants receive usual DM education (30 minutes) and a leaflet. No structured exercise program is provided.

All groups continue receiving standard public-health services. Weekly monitoring and adverse-event checks are performed.

Content Validity Procedures

A content-validity assessment was conducted to ensure standardization of intervention procedures, educational materials, and measurement protocols (foot sensation, vibration, height, weight, blood pressure, ABI). Six experts (physicians or nurses with ≥5 years of DM-related experience) completed item-level ratings using a 1-4 scale. Content Validity Index (CVI) thresholds:

Item-level (I-CVI) ≥ 0.80 Scale-level (S-CVI) ≥ 0.83 Items below threshold were revised based on expert feedback until satisfactory CVI values were achieved. The CVI results showed I-CVI of >0.90 and S-CVI of 0.96.

Participant Recruitment Recruitment was conducted in partnership with the District Health Office and three Public Health Centers (PHCs) in Yogyakarta operating the Chronic Disease Management Program (PROLANIS). PHCs identified potentially eligible adults with DM and supported initial contact. Interested individuals received standardized information regarding study procedures, risks/benefits, confidentiality, and voluntary participation. Those willing attended a screening and informed-consent session. After consent, participants were enrolled and added to the communication group.

Participants received travel reimbursement of IDR 25,000 per data-collection visit. Recruitment materials were approved by the Institutional Review Board (IRB). Participation was voluntary and did not affect access to routine services.

Sample Size A total of 108 participants (36 per group) were enrolled, accounting for an estimated 20% attrition rate. Sample size was selected for feasibility assessment and to provide preliminary, hypothesis-generating estimates for DPN, stress, and DR-QoL outcomes; it was not used to determine the sample size of the subsequent definitive RCT.

Actual Completion Numbers Week 6: control n=35, foot-ankle n=35, walking n=33 Week 12: control n=32, foot-ankle n=34, walking n=34 Per-protocol: control n=31, foot-ankle n=33, walking n=31

Randomization and Allocation Concealment Randomization was performed by independent personnel not involved in recruitment or data collection. A computer-generated sequence with random permuted blocks (sizes 3, 6, and 9) was used with a 1:1:1 allocation ratio.

Assignments were placed in sequentially numbered, sealed, opaque envelopes stored securely and inaccessible to outcome assessors..

Intervention Delivery Control group The active control group was given health education on the topic of DM for 30 minutes and then given a leaflet.

Foot-ankle exercise group

Participants were given health education on DM and foot-ankle exercise after the allocation procedure, followed by simulation and practice lasts 60 minutes. Participants were also given leaflets. Afterward, participants practiced independently without supervision for 12 weeks. Foot-ankle exercise consists of 10 movements. When doing foot-ankle exercises, participants sit comfortably without leaning, and the soles of their feet touch the floor and barefoot. These movements are:

A 1. Lift the soles while heels touch the floor. 2. Flex toes downward (clawing motion). 3. Repeat 10 times. B

1. Lift the soles while heels touch the floor.

2. Lower soles and raise heels while toes touch the floor.

3. Repeat 10 times. C

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1. Lift the soles while heels touch the floor.

2. Perform inward-to-outward circular motions.

3. Repeat 10 times. D

1. Lift both heels while toes touch the floor. 2. Perform inward-to-outward circular motions. 3. Repeat 10 times. E

1. Lift and extend the right knee; left leg remains in original position.

2. Move toes forward and backward.

3. Repeat 10 times; repeat on left leg. F

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1. Lift and extend the right knee.

2. Move toes toward the face.

3. Repeat 10 times; repeat on left leg. G

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1. Lift and extend both knees.

2. Move toes toward the face simultaneously.

3. Repeat 10 times. H

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1. Lift and extend both knees.

2. Move both legs forward.

3. Repeat 10 times. I

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1. Lift and extend the right knee; left leg remains in place.

2. "Write" numbers 1-10 using the right foot.

3. Repeat with the left foot. J

1. Place a sheet of newspaper under both feet. 2. Crumple into a ball using both feet. 3. Open it back into a sheet. 4. Tear into two parts using both feet. 5. Tear one part into small pieces and gather onto the other sheet. 6. Crumple into a ball again. 7. Dispose of the newspaper ball in the trash.

Walking exercise group Participants were given health education for 30 minutes, on DM and walking exercises and leaflet after the allocation procedure. Participants practiced walking exercises independently for 12 weeks.

Health education for all groups is delivered by a certified DM educator. To minimize contamination, group education is conducted on separate days. All participants are added to a moderated WhatsApp group for communication, scheduling, and reminders..

Interventionist dan Outcome Investigators

Interventions are delivered by a health professional with:

• a master's degree in nursing,

• ≥5 years of clinical/educator experience, and
• certification as a DM educator. Each site includes ≥1 outcome investigator who is a registered health worker.

Monitor for Adverse Events Potential adverse events included fatigue, muscle soreness, pain, and dizziness. Participants self-recorded events and reported them during weekly telephone monitoring. If excessive or concerning adverse events were identified, the intervention was stopped and appropriate care provided.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Foot-ankle exercise group

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

Group Type: EXPERIMENTAL

Foot-ankle exercise group

Intervention Type: 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.

Walking exercise group

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

Group Type: EXPERIMENTAL

Walking exercise group

Intervention Type: 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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Siti Fadlilah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siti Fadlilah

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Puskesmas Ngaglik 1

Sleman, Special Region of Yogyakarta, Indonesia

Puskesmas Ngemplak 1

Sleman, Special Region of Yogyakarta, Indonesia

Puskesmas Ngemplak 2

Sleman, Special Region of Yogyakarta, Indonesia

Countries

Indonesia

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Related Links

http://www.diabetesatlas.org

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

Other Identifiers

PilotStudyRCT024_Siti Fadlilah

Identifier Type: -

Identifier Source: org_study_id