Foot-Ankle Exercise and Walking Exercise on Diabetes Mellitus Patients

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

Interventions

OTHER

Foot-ankle exercise

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.

OTHER

Walking exercise

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.

OTHER

Usual care and health education

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.

Sponsors & Collaborators

• Taipei Medical University

  lead OTHER

Principal Investigators

• Siti Fadlilah · Taipei Medical University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-04

Primary Completion

2025-01-15

Completion

2025-01-15

Countries

• Indonesia

Study Locations