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

October 27, 2021 updated by: Taipei Veterans General Hospital, Taiwan
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The exercise group
The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks.
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.
No Intervention: The control groups
The control group received usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing
Time Frame: during 12 weeks the intervention period.
wound size(cm2)
during 12 weeks the intervention period.
blood sugar control-fasting blood sugar
Time Frame: during 12 weeks the intervention period.
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
Time Frame: 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
during 12 weeks the intervention period.
blood sugar control-HbA1c
Time Frame: during 12 weeks the intervention period.
The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term
during 12 weeks the intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2016

Primary Completion (Anticipated)

November 11, 2021

Study Completion (Anticipated)

November 11, 2021

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-08-006B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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