Back to resultsBreathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot, Resistance Exercise, Wound Healing
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
leg resistance combined with breathing exercise training
Sponsored by
About this trial
This is an interventional health services research trial for Diabetic Foot
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The exercise group
The control groups
Arm Description
The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks.
The control group received usual care
Outcomes
Primary Outcome Measures
wound healing
wound size(cm2)
blood sugar control-fasting blood sugar
fasting blood sugar(mg/dl ) using a blood glucose meter
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
blood sugar control-HbA1c
The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term
Secondary Outcome Measures
Full Information
NCT ID
NCT05110092
First Posted
September 6, 2021
Last Updated
October 27, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05110092
Brief Title
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
Official Title
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
November 11, 2021 (Anticipated)
Study Completion Date
November 11, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Resistance Exercise, Wound Healing, Hyperglycemia, Quality of Life
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The exercise group
Arm Type
Experimental
Arm Description
The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks.
Arm Title
The control groups
Arm Type
No Intervention
Arm Description
The control group received usual care
Intervention Type
Behavioral
Intervention Name(s)
leg resistance combined with breathing exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
wound healing
Description
wound size(cm2)
Time Frame
during 12 weeks the intervention period.
Title
blood sugar control-fasting blood sugar
Description
fasting blood sugar(mg/dl ) using a blood glucose meter
Time Frame
during 12 weeks the intervention period.
Title
quality of life measured by the World Health Organization Quality of Life-BREF
Description
Quality of life was measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) in the Taiwan version
Time Frame
during 12 weeks the intervention period.
Title
blood sugar control-HbA1c
Description
The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term
Time Frame
during 12 weeks the intervention period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
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