Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Puskesmas Batang
Coordinator of this site? Confirm its status
BatangIndonesiaUnknown status
Puskesmas Musuk
Coordinator of this site? Confirm its status
BoyolaliIndonesiaUnknown status
Puskesmas Kalasan
Coordinator of this site? Confirm its status
SlemanIndonesiaUnknown status
DPM Alexander
Coordinator of this site? Confirm its status
SlemanIndonesiaUnknown status
UPT Puskesmas Lunyuk
Coordinator of this site? Confirm its status
SumbawaIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.