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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05110092
Other study ID # 2016-08-006B
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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