Diabetes MellitusNCT01760707
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
A study testing exercise training in people with Diabetes Mellitus and Peripheral Neuropathy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Peripheral Neuropathy
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2002to May 2003
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with neuropathy.
Who cannot join
- Central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms.
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy
- Being tested
- exercise training, usual care
- Keywords
- Diabetes mellitus, Peripheral neuropathy, Exercise, Balance performance
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
usual careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | aerobic exercise training Receives: Behavioral: exercise training |
| Control | Active comparator | Not described Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
oxygen consumption
Measured: 8 weeks
Secondary outcomes (1)
maximal oxygen pulse
maximal oxygen content in blood of each heart beat
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startNov 2002
- Primary completionApr 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Tai Wu, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760707
- Sponsor's protocol ID
- 9200200769
- Other IDs
- NSC92-2314-B-002-130
- Status last verified
- Nov 2012
- First submitted
- 2 Jan 2013
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
- ClinicalTrials.gov ID
- NCT01760707
- Acronym / sponsor ID
- 9200200769
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy
- Keywords
- Diabetes mellitus, Peripheral neuropathy, Exercise, Balance performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 4 Jan 2013 (estimated)
- 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 to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Behavioral: exercise trainingaerobic exercise training |
| Control | Active comparator | Behavioral: usual care |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes with neuropathy.
Key exclusion criteria (1 listed)
- Central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.
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 |
|---|---|---|
| exercise training | Behavioural | Exercise Training |
| usual care | Behavioural | Control |
Primary outcome
Exercise capacity
Time frame: 8 weeks
oxygen consumption
1 secondary outcome
maximal oxygen pulse
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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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.
Ying-Tai Wu, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Diabetes Mellitus and Peripheral Neuropathy, run by National Taiwan University Hospital at 1 site in 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise capacity (time frame: 8 weeks). 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 4 Jan 2013.