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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05110092
• Other study ID #: 2016-08-006B
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 14, 2016
• Est. completion date: November 11, 2021

Study information

• Verified date: October 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Hyperglycemia
• Quality of Life
• Resistance Exercise
• Wound Healing
• Wounds and Injuries

Intervention

Behavioral:
• leg resistance combined with breathing exercise training
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing	wound size(cm2)	during 12 weeks the intervention period.
Primary	blood sugar control-fasting blood sugar	fasting blood sugar(mg/dl ) using a blood glucose meter	during 12 weeks the intervention period.
Primary	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.
Primary	blood sugar control-HbA1c	The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term	during 12 weeks the intervention period.