NCT06518486Completed
Foot-Ankle Exercise and Walking Exercise on Diabetes Mellitus Patients
The Effectiveness of Foot-Ankle Exercise and Walking Exercise on Foot Neuropathy, Stress, Quality of Life, Blood Sugar Markers, Blood Pressure, Ankle-Brachial Index, and BMI Among Diabetes Mellitus Patients
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 375 (actual)
- First submitted
- 18 Jul 2024
- Start date
- 4 Oct 2024
- Primary completion date
- 15 Jan 2025
- Lead sponsor
- Taipei Medical University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06518486
What you commit to
- Study type: Interventional
- Participants enrolled: 375
- From 4 Oct 2024 to the primary completion date, 15 Jan 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- DM patients with foot ulcers
- DM patients with fractures or difficulty using the lower extremities
Who the study is looking for
- 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
Age in the registry: 20 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Puskesmas Batang Coordinator of this site? Confirm its status | Batang | Indonesia | Unknown status |
| Puskesmas Musuk Coordinator of this site? Confirm its status | Boyolali | Indonesia | Unknown status |
| Puskesmas Kalasan Coordinator of this site? Confirm its status | Sleman | Indonesia | Unknown status |
| DPM Alexander Coordinator of this site? Confirm its status | Sleman | Indonesia | Unknown status |
| UPT Puskesmas Lunyuk Coordinator of this site? Confirm its status | Sumbawa | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.