Foot-Ankle Exercise and Walking Exercise on Diabetes Mellitus Patients

NCT06518486 | Completed DMC

• 1 other identifier: RCT2024_Siti Fadlilah
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Diabetes Type 2; Diabetes; Diabetes Mellitus; Diabetes Complications

Keywords

Foot sensitivity; Stress; Quality of life; Fasting blood glucose; Body mass index; Blood pressure; Ankle-brachial index; Diabetes mellitus; Diabetic peripheral Neuropathies

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Fasting Blood Glucose (FBG) of People with Diabetes Mellitus

  Baseline (before intervention/0 week), at 6-weeks and 12-weeks

• Blood Pressure of People with Diabetes Mellitus

  Baseline (before intervention/0 week), at 6-weeks and 12-weeks

• Body Mass Index of People with Diabetes Mellitus

  Baseline (before intervention/0 week), at 6-weeks and 12-weeks

• Ankle-Brachial Index (ABI) of People with Diabetes Mellitus

  Baseline (before intervention/0 week), at 6-weeks and 12-weeks

• Adherence Participants in Experimental Group

  12-weeks

Study Arms (3)

Foot-ankle exercise group

EXPERIMENTAL

The group received intervention through health education, simulations, leaflets, and videos about foot-ankle exercise and practised independently for 12 weeks.

Other: Foot-ankle exercise

Walking exercise group

EXPERIMENTAL

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

Other: Walking exercise

Control group

ACTIVE COMPARATOR

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

Other: Usual care and health education

Interventions

Foot-ankle exercise OTHER

Foot-ankle exercise group will receive usual care provide by public health center and intervention through health education, leaflets, and videos about foot-ankle exercise. At the first meeting, participants will be taught how to do foot exercises and practice them in front of the instructor. Afterwards, participants will practice foot exercises independently without supervision for 12 weeks. One foot exercise session takes 10-15 minutes, while the physical activity target is for participants to fulfil a moderate level of physical activity (150 minutes/week). For this reason, participants are advised to do foot exercises for 2-3 sessions every day. The minimum duration of each session is 10 minutes, and two consecutive days without foot exercise are not allowed. Participants are asked to document all foot exercise practices in the logbook given at the first meeting. To monitor the intervention, we will contact participants by telephone for ±5 minutes/week.

Foot-ankle exercise group

Walking exercise OTHER

Participants in the walking exercise group will receive usual care provide by public health center and intervention through health education and leaflets about walking exercise. Participants will practice walking exercises independently without supervision for 12 weeks. Participants walked at the same speed as they did every day. The physical activity target to be achieved is for participants to be able to engage in a moderate level of physical activity (150 minutes/week). For this reason, participants are advised to do walking exercises with a minimum duration of 10 minutes for each session. Two consecutive days without walking exercise are not allowed, and a minimum of 150 minutes/week is allowed. Participants are asked to document all walking exercise practices in the logbook given at the first meeting. To monitor the intervention, we will contact participants by telephone for ±5 minutes/week.

Walking exercise group

Usual care and health education OTHER

Participants in the control group will receive 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 (5)

Puskesmas Batang

Batang, Central Java, Indonesia

Location

Puskesmas Musuk

Boyolali, Central Java, Indonesia

Location

DPM Alexander

Sleman, Special Region of Yogyakarta, Indonesia

Location

UPT Puskesmas Lunyuk

Sumbawa, West Nusa Tenggara, Indonesia

Location

Puskesmas Kalasan

Sleman, Yogyakarta and West Nusa Tenggara, Indonesia

Location

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Related Links

• International Diabetes Federation, I. (2021). IDF Diabetes Atlas 10th edition.

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Diabetes Mellitus; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

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: PREVENTION
• 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: July 18, 2024
• First Posted: July 24, 2024
• Study Start: October 4, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-02

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 (5)