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

NCT ID: NCT07262203

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-06-30

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.

Detailed Description

This randomized controlled trial was conducted to determine the effectiveness of diabetic foot exercises in improving peripheral vascular status among patients with type 2 diabetes mellitus (T2DM). Diabetes mellitus is a chronic metabolic disorder associated with multiple vascular complications, including peripheral artery disease (PAD). PAD in diabetic patients is frequently asymptomatic during the early stages, yet it substantially increases the risk of ischemia, ulceration, and lower-limb amputation. Regular physical activity and targeted exercises have been shown to improve circulation and functional capacity. However, evidence regarding the effects of specific diabetic foot exercise programs on peripheral vascular status remains limited in Indonesia.

A total of 44 participants with T2DM were recruited from PERSADIA at Dr. Moewardi Hospital, Central Java, Indonesia. Participants were randomly assigned to either the treatment group (n = 22) or control group (n = 22) using a card-shuffle randomization method. Inclusion criteria included age above 50 years and a diagnosis of T2DM for at least 5 years. Exclusion criteria included inability to walk independently, lower extremity pain, severe arthritis, neurological or cardiovascular disorders, limited physical activity, or cognitive impairment. All participants provided written informed consent before enrollment.

The intervention consisted of a structured diabetic foot exercise program adapted from the Joslin Diabetes Center, involving quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. Participants in the intervention group were instructed to perform the exercises daily for approximately 30 minutes over a period of 3 months, with monitoring to ensure safety. The control group participated in regular physical activity of similar duration and frequency but without the targeted diabetic foot exercise components.

Peripheral vascular status was assessed through the ankle-brachial index (ABI), using a Doppler device (ES-1000SPM, Hadeco, Japan). ABI measurements were taken at baseline and after 3 months of intervention, following standard procedures, including supine positioning and an initial rest period of five minutes. ABI categories followed established clinical thresholds: normal (0.90-1.30), mild impairment (0.70-0.89), moderate impairment (0.40-0.69), and severe impairment (<0.40).

Data analysis was performed using SPSS, employing paired t-tests for within-group comparisons and independent t-tests for between-group differences. The results demonstrated a significant improvement in ABI values in the intervention group (from 0.90 ± 0.05 to 0.96 ± 0.06), compared to minimal changes in the control group (from 0.90 ± 0.04 to 0.91 ± 0.05). These findings suggest that diabetic foot exercises can effectively enhance peripheral vascular function.

This study highlights that diabetic foot exercises offer a practical, low-cost, and accessible method for improving lower-extremity circulation in people with type 2 diabetes. Unlike intensive exercise programs requiring specialized equipment or supervision, this intervention is feasible for implementation in community settings and resource-limited environments. Although the study involved a relatively small sample size, the statistical power was acceptable, and the results align with previous evidence showing that lower extremity exercise improves vascular health.

Future studies with larger populations and longer follow-up periods are recommended to explore the long-term vascular and metabolic benefits of diabetic foot exercise programs

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diabetic Foot Exercise Intervention

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.

Group Type: EXPERIMENTAL

Diabetic Foot Exercise Program

Intervention Type: 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

Control - Usual Physical Activity

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diabetic Foot Exercise Program

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Diabetic Foot Exercises; Foot Exercise Regimen

Eligibility Criteria

Inclusion Criteria

1. Adults aged > 50 years

2. Diagnosed with Type 2 Diabetes Mellitus for ≥ 5 years

3. Able to walk independently

4. Willing to participate for the full 3-month intervention period

5. Provided written informed consent

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Muhammadiyah Surakarta

OTHER

Sponsor Role: lead

Responsible Party

Fahrun Nur Rosyid

Dr.Fahrun Nur Rosyid, S.Kep., Ns., M .Kes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faculty of Health Sciences FIK UMS

Role: PRINCIPAL_INVESTIGATOR

Universitas Muhammadiyah Surakarta

Locations

RSUD Dr. Moewardi Surakarta

Surakarta, Centre Java, Indonesia

Countries

Indonesia

Other Identifiers

UMS-DFET2DM-2024

Identifier Type: -

Identifier Source: org_study_id