Diabetic FootNCT05110092
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
A study testing leg resistance combined with breathing exercise training in people with Diabetic Foot and Resistance Exercise, run by Taipei Veterans General Hospital, Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Resistance Exercise, Wound Healing
- What is being tested?
- leg resistance combined with breathing exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2016to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- peripheral arterial occlusion disease
- osteomyelitis
- inability to perform exercise as assessed by physicians.
About this study
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.
Read the 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.
- Being tested
- leg resistance combined with breathing exercise training
- Medical subject headings
- Diabetic Foot, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg resistance combined with breathing exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The exercise group | Experimental | The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. Receives: Behavioral: leg resistance combined with breathing exercise training |
| The control groups | No intervention | The control group received usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
wound size(cm2)
Measured: during 12 weeks the intervention period.
blood sugar control-fasting blood sugar
fasting blood sugar(mg/dl ) using a blood glucose meter
Measured: during 12 weeks the intervention period.
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
Measured: during 12 weeks the intervention period.
blood sugar control-HbA1c
The levels of hemoglobin A1c (%)(HbA1c) were monitored blood sugar in the long term
Measured: during 12 weeks the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start14 Dec 2016
- Primary completion11 Nov 2021 (estimated)
- Study completion11 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110092
- Sponsor's protocol ID
- 2016-08-006B
- Status last verified
- Oct 2021
- First submitted
- 6 Sep 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05110092
- Acronym / sponsor ID
- 2016-08-006B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 11 Nov 2021 (estimated)
- Study completion
- 11 Nov 2021 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The exercise group | Experimental | Behavioral: leg resistance combined with breathing exercise trainingThe exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. |
| The control groups | No intervention | –The control group received usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- peripheral arterial occlusion disease
- osteomyelitis
- inability to perform exercise as assessed by physicians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leg resistance combined with breathing exercise trainingThe 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. | Behavioural | The exercise group |
Primary outcome
wound healing
Time frame: during 12 weeks the intervention period.
wound size(cm2)
blood sugar control-fasting blood sugar
Time frame: during 12 weeks the intervention period.
fasting blood sugar(mg/dl ) using a blood glucose meter
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing leg resistance combined with breathing exercise training in people with Diabetic Foot and Resistance Exercise, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: during 12 weeks the intervention period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.