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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05110092
Collaborator
(none)
64
2
58.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: leg resistance combined with breathing exercise training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Health Services Research
Official Title:
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
Actual Study Start Date :
Dec 14, 2016
Anticipated Primary Completion Date :
Nov 11, 2021
Anticipated Study Completion Date :
Nov 11, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. wound healing [during 12 weeks the intervention period.]

    wound size(cm2)

  2. blood sugar control-fasting blood sugar [during 12 weeks the intervention period.]

    fasting blood sugar(mg/dl ) using a blood glucose meter

  3. 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

  4. blood sugar control-HbA1c [during 12 weeks the intervention period.]

    The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05110092
Other Study ID Numbers:
  • 2016-08-006B
First Posted:
Nov 5, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2021