Foot-Ankle Exercise and Walking Exercise on Diabetes Mellitus Patients
NCT Number: NCT06518486
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot|Diabetes Mellitus, Type 2|Diabetic Neuropathies|Diabetes Type 2|Diabetes|Diabetes Mellitus|Diabetes Complications
Interventions: OTHER: Foot-ankle exercise|OTHER: Walking exercise|OTHER: Usual care and health education
Sponsor: Taipei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 315
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2024-11-30
Locations: Puskesmas Batang, Batang, Central Java, Indonesia|Puskesmas Musuk, Boyolali, Central Java, Indonesia|UPT Puskesmas Lunyuk, Sumbawa, West Nusa Tenggara, Indonesia|Puskesmas Kalasan, Sleman, Yogyakarta And West Nusa Tenggara, Indonesia|DPM Alexander, Sleman, Yogyakarta, Indonesia

Summary:
The primary purpose of this study is to determine the effectiveness of foot-ankle exercise and walking exercise on foot neuropathy, stress, and quality of life (QoL) among people with diabetes mellitus (PWDM). At the same time, the secondary purpose of this study is to determine the effectiveness of foot-ankle exercise and walking exercise on body mass index (BMI), fasting blood glucose (FBG), blood pressure (BP), and ankle-brachial index (ABI) among PWDM at baseline (before intervention/0 week), at 6-weeks and 12-weeks.

The research questions in this study include the following:

* Is foot-ankle exercise effective for foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI for PWDM?
* Is walking exercise effective for foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI for PWDM?
* Are there any differences in the mean scores of foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI of PWDM within and between the foot-ankle exercise, walking exercise and control group at baseline, 6 weeks, and 12 weeks?
* Are there any mediators/moderators effect of BMI, FBG, blood pressure, ABI, and stress for influencing foot exercise and walking exercise interventions on foot neuropathy and QoL for PWDM?

Participants in the foot-ankle exercise group will be given health education about DM and foot-ankle exercise, as well as leaflets and videos. Participants will be taught how to practice foot-ankle exercises before the instructor. Afterwards, participants will practice foot-ankle exercises independently without supervision for 2-3 sessions every day for 12 weeks. Participants in the walking exercise group will be given health education about DM, walking exercises and leaflets. Participants will practice walking exercises independently without supervision for 12 weeks. Participants are advised to do walking exercises with a minimum duration of 10 minutes for each session and 150 minutes/week. Two consecutive days without walking exercise are not allowed. Participants in the control groups will be treated as active control and given health education on general DM topics and leaflets. All groups received usual care according to standards provided by public health services. Researchers will compare the groups to see the effect of the interventions on foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI at three different time points: at baseline, 6 weeks, and 12 weeks.

Primary Outcome Measures: Foot Neuropathy of People with Diabetes Mellitus, Foot neuropathy will be measured by MNSI. MNSI consist of MNSI-A (questionnaire) and MNSI-B (physical examination). Foot sensation will be measured using Semmes Weinstein Monofilament 10g. Participants will be given a stimulus for 1.5-2 seconds at 10 points on both legs. The locations are heel, dorsal surface of the foot (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 will be 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 will record 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)., Baseline (before intervention/0 week), at 6-weeks and 12-weeks|Stress of People with Diabetes Mellitus, Stress will be measured using the Indonesian version of the Problem Areas in Diabetes (PAID) questionnaire. This study uses 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 0-80, with a higher score indicating greater stress., Baseline (before intervention/0 week), at 6-weeks and 12-weeks|Quality of Life of People with Diabetes Mellitus, QoL will be measured using the Indonesian version of the Diabetes Obstacles Questionnaire Short Version (DOQ-30) which we have previously tested for validity and reliability. DOQ-30 Bahasa Indonesia has nine factors and a 5-point Likert scale with answer options never (5), almost never (4), sometimes (3), often (2), and always (1). The total score ranges 30-150, with a higher score indicating a better QoL. 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., Baseline (before intervention/0 week), at 6-weeks and 12-weeks
Secondary Outcome Measures: Fasting Blood Glucose (FBG) of People with Diabetes Mellitus, 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., Baseline (before intervention/0 week), at 6-weeks and 12-weeks|Blood Pressure of People with Diabetes Mellitus, Blood pressure will be 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 position. Blood pressure consists of SBP and 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., Baseline (before intervention/0 week), at 6-weeks and 12-weeks|Body Mass Index of People with Diabetes Mellitus, 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., Baseline (before intervention/0 week), at 6-weeks and 12-weeks|Ankle-Brachial Index (ABI) of People with Diabetes Mellitus, ABI measurements will be carried out using continuous-wave Doppler ultrasound using SOPs prepared previously. Participants were asked to rest for at least 5 minutes, and measurements were taken in the supine position. BP 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 will be calculated using the ankle SBP/brachial SBP formula. The results of these calculations produce the right and left ABI. The analysis will use the lowest ABI value between the two legs. The measurement results are documented in the observation sheet., Baseline (before intervention/0 week), at 6-weeks and 12-weeks|Adherence Participants in Experimental Group, The compliance of participants in both intervention groups in carrying out the program provided was measured using documentation from the logbook at the beginning of the meeting. The logbook contains information on the day, date, and time from start to finish, and it ends with the participant's signature., 12-weeks