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

Not Applicable

• Conditions: Diabetic Foot; Hyperglycemia; Resistance Exercise; Wound Healing; Quality of Life
• Interventions: Behavioral: leg resistance combined with breathing exercise training

• Registration Number: NCT05110092
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2016-12-14
• Study First Submitted: 2021-09-06
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05
• Primary Completion: 2021-11-11
• Study Completion: 2021-11-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The exercise group	leg resistance combined with breathing exercise training	The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks.

Primary Outcome Measures

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