Effect of Diabetic Foot Exercises on Peripheral Vascular Status in Type 2 Diabetes Mellitus Patients

NCT07262203 | Completed

• 1 other identifier: UMS-DFET2DM-2024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of diabetic foot exercises on peripheral vascular status among patients with type 2 diabetes mellitus. Peripheral artery disease is a common complication of diabetes and contributes to reduced mobility and increased risk of ulcers, ischemia, and amputation. Early identification and non-pharmacological interventions such as structured lower extremity exercises may help improve peripheral circulation. In this study, 44 adults with type 2 diabetes mellitus who met the inclusion criteria were randomly assigned to either an intervention group receiving diabetic foot exercises or a control group performing regular physical activity of similar frequency and duration. The exercise protocol used in the intervention group was adapted from the Joslin Diabetes Center and included balance, strengthening, and ankle-foot mobility exercises. The intervention lasted for 3 months. Peripheral vascular status was assessed using the ankle-brachial index (ABI) measured with a Doppler device at baseline and after 3 months. The study found that participants in the intervention group demonstrated a significant improvement in ABI values compared with the control group, indicating enhanced lower-limb blood flow. This trial provides evidence that diabetic foot exercises are a simple, low-cost, and feasible intervention to improve peripheral vascular circulation in patients with type 2 diabetes mellitus, particularly in settings with limited resources.

Conditions

Peripheral Artery Disease (PAD); Diabetes Mellitus Type 2; Diabetic Foot Circulation Impairment

Keywords

diabetic foot exercises; peripheral vascular; ankle brachial index; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Ankle-Brachial Index (ABI)

  Ankle-Brachial Index (ABI) is measured using a handheld Doppler device (ES-1000SPM, Hadeco, Japan). ABI is calculated as the highest ankle systolic pressure (posterior tibial or dorsalis pedis) divided by the highest brachial systolic pressure. Measurements are taken in supine position after 5 minutes rest. ABI values reflect peripheral vascular status, categorized as normal (0.90-1.30), mild (0.70-0.89), moderate (0.40-0.69), and severe (\<0.40). Primary analysis compares the change in ABI from baseline to 3 months between intervention and control groups

  Baseline and 3 months after intervention

Study Arms (2)

Diabetic Foot Exercise Intervention

EXPERIMENTAL

Participants performed a structured diabetic foot exercise program adapted from the Joslin Diabetes Center regimen. Exercises included quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. The program was conducted for 3 months, approximately 30 minutes per day, with monitoring by the research team to maintain safety and adherence. All participants in this arm had type 2 diabetes mellitus. The primary outcome (ankle-brachial index) was measured at baseline and after 3 months.

Behavioral: Diabetic Foot Exercise Program

Control - Usual Physical Activity

NO INTERVENTION

Participants continued their usual physical activities with similar recommended frequency and duration as the intervention group but did not receive the structured diabetic foot exercise program. They continued routine diabetes care and any prescribed DM medications. The control group served as a comparator to assess the effect of the diabetic foot exercise program on ankle-brachial index over 3 months

Interventions

Diabetic Foot Exercise Program BEHAVIORAL

A structured diabetic foot exercise program adapted from the Joslin Diabetes Center protocol. The regimen includes quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. Participants perform the exercises for approximately 30 minutes daily over 3 months under monitoring by the research team. The exercises aim to improve peripheral vascular status and lower-limb circulation. Ankle-brachial index is measured at baseline and after 3 months using a Doppler device

Also known as: Diabetic Foot Exercises, Foot Exercise Regimen

Diabetic Foot Exercise Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \> 50 years
• Diagnosed with Type 2 Diabetes Mellitus for ≥ 5 years
• Able to walk independently
• Willing to participate for the full 3-month intervention period
• Provided written informed consent

You may not qualify if:

• patients who unable to walk independently, had lower limb pain, severe arthritis, cardiovascular or neurological disorders, limited physical activity, or cognitive dysfunction that impaired their ability to follow instructions.

Sponsors & Collaborators

• Universitas Muhammadiyah Surakarta: lead

Study Sites (1)

RSUD Dr. Moewardi Surakarta

Surakarta, Centre Java, 57126, Indonesia

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Faculty of Health Sciences FIK UMS

  Universitas Muhammadiyah Surakarta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Fahrun Nur Rosyid, S.Kep., Ns., M .Kes

Model Details: Randomized, parallel-group controlled trial with two arms (intervention vs control). Participants were randomly allocated (1:1) using a card-shuffle randomization method. The intervention group performed a structured diabetic foot exercise program derived from Joslin Diabetes Center guidelines for three months (≈30 minutes/day, supervised monitoring), while the control group continued usual physical activity of comparable frequency and duration without the specific diabetic foot exercise program. Primary outcome (ankle-brachial index) measured at baseline and after 3 months using Doppler device

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)