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

NCT ID: NCT05110092

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2021-11-11

Brief Summary

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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

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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.

Conditions

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Diabetic Foot Resistance Exercise Wound Healing Hyperglycemia Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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The exercise group

The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks.

Group Type EXPERIMENTAL

leg resistance combined with breathing exercise training

Intervention Type BEHAVIORAL

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.

The control groups

The control group received usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2016-08-006B

Identifier Type: -

Identifier Source: org_study_id