Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was designed leg resistance training combined with breathing approach, and evaluated its effect on wound healing, blood sugar control and quality of life in type 2 diabetic patients with foot ulcers.

Detailed Description
-----------------
A randomized controlled trial was used. type 2 diabetic patients who suffered from foot ulcers were recruited from one medical center of Northern Taiwan, and randomly assigned into the exercise or control group. The control group received usual care for diabetic foot. The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. Outcomes were measured by wound healing area, the fasting of blood glucose, hemoglobin A1c (HbA1c), and the World Health Organization quality of life-BREF (WHOQOL-BREF) before the intervention as baseline, and the 4th, 8th and 12th weeks during the intervention period.

Official Title
-----------------
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers

Conditions
-----------------
Wound Healing, Diabetic Foot, Resistance Exercise, Hyperglycemia, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: leg resistance combined with breathing exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients 20 years or older who were diagnosed with type 2 diabetic foot ulcers of Meggitt-Wagner Grade 1-2 who were conscious and could perform the prescribed exercise. Exclusion Criteria: peripheral arterial occlusion disease osteomyelitis inability to perform exercise as assessed by physicians.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The exercise group<br>The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. | Behavioral: leg resistance combined with breathing exercise training<br>* The exercise group was provided breathing and leg resistance exercise manuals. The exercise involved 5 minutes of abdominal breathing in a relaxed sitting position, followed by 10 minutes of leg resistance training.<br>|
| No Intervention: The control groups<br>The control group received usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing | wound size(cm2) | during 12 weeks the intervention period. | 
| blood sugar control-fasting blood sugar | fasting blood sugar(mg/dl ) using a blood glucose meter | during 12 weeks the intervention period. | 
| quality of life measured by the World Health Organization Quality of Life-BREF | Quality of life was measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) in the Taiwan version | during 12 weeks the intervention period. | 
| blood sugar control-HbA1c | The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term | during 12 weeks the intervention period. |