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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:
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.
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 both heels while toes touch the floor. 2. Perform inward-to-outward circular motions. 3. Repeat 10 times. E
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,
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foot-ankle exercise group | Experimental | The group received intervention through health education, simulations and leaflets about footankle exercise and practised independently for 12 weeks |
|
| Walking exercise group | Experimental | The group received intervention through health education, and leaflets about walking exercise and practised independently for 12 weeks |
|
| Control Group | Active Comparator | The group that received intervention in the form of health education and leaflets about DM in general |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetic Peripeheral Neuropathy (DPN) | DPN measured by Michigan Neuropathy Scale Instrument (MNSI). MNSI consist of MNSI-A (questionnaire) and MNSI-B (physical examination). Foot sensation was measured by Semmes Weinstein Monofilament 10g. Participants were given a stimulus for 1.5-2 seconds at 10 points on both legs. The locations are heel, dorsal surface (between the bases of 1st-2nd toes), toes (1st, 3rd and 5th), metatarsal heads (1st, 3rd, 5th), and midfoot (medial and lateral). The results range from 0-10. Foot vibration measurement using Tunning Fork 128Hz. The vibrating TF were placed on each leg in 4 locations (medial, malleolus, great toe, fifth toe). Participants were asked to feel the vibrations and signal by raising their hands if they were no longer felt. The observer recorded the time from when the participant feels the initial until it disappears. The results consist of whether the participant felt the vibration or not (0-4) and the length of time participants can feel the vibration (in seconds). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siti Fadlilah | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Ngaglik 1 | Sleman | Special Region of Yogyakarta | Indonesia | |||
| Puskesmas Ngemplak 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32258170 | Background | Henderson AD, Johnson AW, Rasmussen LG, Peine WP, Symons SH, Scoresby KA, Ridge ST, Bruening DA. Early-Stage Diabetic Neuropathy Reduces Foot Strength and Intrinsic but Not Extrinsic Foot Muscle Size. J Diabetes Res. 2020 Mar 12;2020:9536362. doi: 10.1155/2020/9536362. eCollection 2020. | |
| 34867812 | Result | Zhu X, Zhao L, Chen J, Lin C, Lv F, Hu S, Cai X, Zhang L, Ji L. The Effect of Physical Activity on Glycemic Variability in Patients With Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Endocrinol (Lausanne). 2021 Nov 17;12:767152. doi: 10.3389/fendo.2021.767152. eCollection 2021. |
| Label | URL |
|---|---|
| International Diabetes Federation, I. (2021). IDF Diabetes Atlas 10th edition. Available IPD/Information: | View source |
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Particular data will be shared: Individual participant data that underlie the results reported in this article after identification (text, tables, figures, and appendices).
Beginning 9 months and ending 60 months following article publication.
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.
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Three arms parallel group design with 2 group interventions (foot-ankle exercise and walking exercise) and 1 control group
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Data collectors who assess the outcomes and statistician who analyse the data are blinded.
|
| 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. |
|
| 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. |
|
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. |
| 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 | Stress was measured using the Indonesian version of the Problem Areas in Diabetes (PAID) questionnaire. This study used PAID Bahasa Indonesia, which we have previously tested for validity and reliability. PAID Bahasa Indonesia has 20 items and three factors, with a loading factor of 0.349-0.779 for each item. The results of exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) show valid and reliable results. Cronbach's alpha for all items is 0.858, inter-class correlation 0.938, RMSEA=0.058, and SRMR=0.062. PAID Bahasa Indonesia consist of five answer choices using a Likert scale (0-4). The answer choice scores used were 'not a problem' (0), 'minor problem' (1), 'moderate problem' (2), 'somewhat serious problem' (3), and 'serious problem' (4). The total score ranged 0-100, with a higher score indicating greater 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) | Obstacles to DR-QoL measured using the Indonesian version of the Diabetes Obstacles Questionnaire Short Version (DOQ-30) which we have previously tested for validity and reliability. Factors in the DOQ-30 are relationships with medical professionals, support from friends and family, knowledge of the disease, lifestyle changes, exercising, self-monitoring, uncertainty about a consultation, medication, and insulin use. EFA and CFA analysis showed valid and reliable results; Cronbach's alpha for all items was 0.930, and individual factors ranged from 0.730 to 0.848. The test-retest results were excellent (with interclass correlation coefficients of 0.910 to 0.973). The CFA test obtained RMSEA=0.057 and SRMR=0.067, indicating a good model fit. The DOQ-30 contains nine domains and 30 items rated on a 0-4 Likert scale ("never" to "always"), with scores standardized from 0 (no obstacles) to 1 (worst possible obstacles). | 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) | FBG were measured using venous blood after the respondent fasted for at least 8 hours. Blood analysis is carried out in the laboratory using the hexokinase enzymatic method. The researchers did not carry out this analysis, but they collaborated with the Independent Clinical Laboratory. All participants were measured according to standard operating procedures as a guide. The measurement results are documented in the observation sheet. The process of taking venous blood is carried out by nursing staff with the criteria of having a competency certificate and working for a minimum of 3 years. | 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 | Blood pressure was measured using a digital tensimeter, The Omron M3 Intellisense (Omron Healthcare Co Ltd), validated in previous research. Participants were asked to rest for at least 5 minutes before the measurement. Measurements were taken on the left arm in a sitting or supine position. Blood pressure consists of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in mmHg units. Then, the mean atrial pressure (MAP) will be calculated using the formula, MAP = DBP + 1/3(SBP - DBP) or MAP = DBP + 1/3(pulse pressure/PP) All participants were measured according to standard operating procedures as a guide. The measurement results are documented in the observation sheet. | 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. |
| Body Mass Index (BMI) | Participants were asked to stand up straight and remove footwear when their height and weight were checked. Body weight was measured using digital scales, and height using height-measuring devices. BMI is calculated using the formula body weight (kg) divided by height2 (m2). All participants were measured according to standard operating procedures as a guide. The measurement results are documented in the observation sheet | From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which BMI was measured at Baseline, Week 6, and Week 12 over an actual 12-week period. |
| Ankle-Brachial Index (ABI) | ABI measurements carried out using continuous-wave Doppler ultrasound. Participants were asked to rest for at least 5 minutes, and measurements were taken in the supine position. Blood pressure was measured twice each at four locations: right arm, left arm, right leg and left leg. Arm blood pressure was measured by Doppler ultrasound in the humeral artery, while leg blood pressure was placed in the tibial artery. The cuff is inflated 20-30 mmHg and deflated slowly. The first sound heard is systolic blood pressure. The average blood pressure results from the two measurements at each location will be calculated to obtain the average blood pressure in the right arm, left arm, right leg and left leg. ABI calculated using the ankle SBP/brachial SBP formula. The results of these calculations produce the right and left ABI. | From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which ABI was measured at Baseline, Week 6, and Week 12 over an actual 12-week period. |
| Sleman |
| Special Region of Yogyakarta |
| Indonesia |
| Puskesmas Ngemplak 2 | Sleman | Special Region of Yogyakarta | Indonesia |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D017719 | Diabetic Foot |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
Not provided
Not provided