Diabetic Peripheral NeuropathyNCT03450200
Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
A study testing exercises for diabetic peripheral neuropathy and Health education for diabetic foot care in people with Diabetic Peripheral Neuropathy, run by Okayama University at 1 site in Japan.
Trial summary
Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic patients. Moreover, it will lead to another complication as disabilities and difficulties in activities of daily living (ADL). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- exercises for diabetic peripheral neuropathy and Health education for diabetic foot care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteJapan
- Study dates
- 17 Jun 2017to 16 Oct 2017
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients receiving diabetic care at the out-patient-department of designated hospitals, able to contact via the telephone, presence of signs and symptoms of DPN, agreed to involve in the study (informed consent), and aged over 25 years
Who cannot join
- The persons who are suffering from DPN other than diabetes, severe illness of diabetic patients, diabetes with other comorbidities, amputation of hands and feet from any reasons, mental illness and alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic patients. Moreover, it will lead to another complication as disabilities and difficulties in activities of daily living (ADL). Most of the intervention for diabetes and diabetic neuropathic patients are mostly focusing on the prevention of foot ulcer. Diabetic foot care can prevent only for diabetes-related foot ulcer and foot amputation. It cannot be reduced DPN and cannot be improved the activities of daily living of the patient with DPN. Moreover, there is the restriction of weight-bearing exercise on the recommendation of exercises for the patients with DPN. Therefore, exercise program which may be suitable for all the patients with DPN was introduced in this study to improve ADL and decrease the neuropathic symptoms in the diabetic patients.
Compliance with exercise or intervention is not only critical to get adherence but also for the long-term use of its. Easy to do exercise in the short duration which can able to do on their own in their home promote their compliance and adherence to the exercises. In this study, the effectiveness of exercises in the patients with diabetic peripheral neuropathy was examined to fulfill the requirement of exercises which is simple and can be done in a short time. The objective of the study is to examine the effectiveness of exercise in the patients with diabetic peripheral neuropathy.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- exercises for diabetic peripheral neuropathy, Health education for diabetic foot care
- Keywords
- Diabetic Peripheral Neuropathy, Exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercises for diabetic peripheral neuropathyOther
Hands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN
Health education for diabetic foot careOther
Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.
| Study group | Role | What they receive |
|---|---|---|
| Exercises Group | Experimental | three times daily exercises of hands and fingers exercises and foot exercises which last for 10 minutes in eight weeks, and health education about diabetic foot care Receives: Other: exercises for diabetic peripheral neuropathy; Other: Health education for diabetic foot care |
| Control Group | Other | health education about diabetic foot care Receives: Other: Health education for diabetic foot care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activities of daily living (ADLs) after intervention, at follow-up
ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).
Measured: eight weeks after intervention, eight weeks follow-up
Change in signs of DPN after intervention, at follow-up
DPN was assessed by using monofilament (SMW), Touch-TestTM Sensory Evaluator 5 Pieces Hand Kit of North Coast Medical Inc.
Measured: eight weeks after intervention, eight weeks follow-up
Change in signs of DPN after intervention, at follow-up
DPN was assessed by tuning fork vibration test.
Measured: eight weeks after intervention, eight weeks follow-up
Secondary outcomes (3)
Change in strength of hand grip
Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.
Measured: eight weeks after intervention, eight weeks follow-up
Change in strength of pinch force
Key (lateral pinch) was measured by the gold standard B\&L Engineering® Pinch Gauge 0-30 lb. in 1.0 lb.
Measured: eight weeks after intervention, eight weeks follow-up
Change in walking speed
Timed Up and Go (TUG) test was to measure the duration for walking in seconds.
Measured: eight weeks after intervention, eight weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start17 Jun 2017
- Primary completion16 Oct 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Mi Thet Mon Win, Okayama University
- Investigators
- Mi Mi Thet Mon Win, PhD student, Principal investigator, Graduate School of Health Sciences, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450200
- Sponsor's protocol ID
- D16-07
- Other IDs
- Ethics/DMR/2017/048
- Status last verified
- May 2019
- First submitted
- 19 Feb 2018
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03450200
- Acronym / sponsor ID
- D16-07
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetic Peripheral Neuropathy, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 1 Mar 2018 (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.
Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic patients. Moreover, it will lead to another complication as disabilities and difficulties in activities of daily living (ADL). Most of the intervention for diabetes and diabetic neuropathic patients are mostly focusing on the prevention of foot ulcer. Diabetic foot care can prevent only for diabetes-related foot ulcer and foot amputation. It cannot be reduced DPN and cannot be improved the activities of daily living of the patient with DPN. Moreover, there is the restriction of weight-bearing exercise on the recommendation of exercises for the patients with DPN. Therefore, exercise program which may be suitable for all the patients with DPN was introduced in this study to improve ADL and decrease the neuropathic symptoms in the diabetic patients.
Compliance with exercise or intervention is not only critical to get adherence but also for the long-term use of its. Easy to do exercise in the short duration which can able to do on their own in their home promote their compliance and adherence to the exercises. In this study, the effectiveness of exercises in the patients with diabetic peripheral neuropathy was examined to fulfill the requirement of exercises which is simple and can be done in a short time. The objective of the study is to examine the effectiveness of exercise in the patients with diabetic peripheral neuropathy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises Group | Experimental | Other: exercises for diabetic peripheral neuropathy, Other: Health education for diabetic foot carethree times daily exercises of hands and fingers exercises and foot exercises which last for 10 minutes in eight weeks, and health education about diabetic foot care |
| Control Group | Other | Other: Health education for diabetic foot carehealth education about diabetic foot care |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients receiving diabetic care at the out-patient-department of designated hospitals, able to contact via the telephone, presence of signs and symptoms of DPN, agreed to involve in the study (informed consent), and aged over 25 years
Key exclusion criteria (1 listed)
- The persons who are suffering from DPN other than diabetes, severe illness of diabetic patients, diabetes with other comorbidities, amputation of hands and feet from any reasons, mental illness and alcoholism
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 |
|---|---|---|
| exercises for diabetic peripheral neuropathyHands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN | Other | Exercises Group |
| Health education for diabetic foot careHealth education for daily diabetic foot care to prevent diabetic foot ulcer was provided. | Other | Control Group, Exercises Group |
Primary outcome
Change in Activities of daily living (ADLs) after intervention, at follow-up
Time frame: eight weeks after intervention, eight weeks follow-up
ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).
Change in signs of DPN after intervention, at follow-up
Time frame: eight weeks after intervention, eight weeks follow-up
DPN was assessed by using monofilament (SMW), Touch-TestTM Sensory Evaluator 5 Pieces Hand Kit of North Coast Medical Inc.
Change in signs of DPN after intervention, at follow-up
Time frame: eight weeks after intervention, eight weeks follow-up
DPN was assessed by tuning fork vibration test.
3 secondary outcomes
Change in strength of hand grip
Time frame: eight weeks after intervention, eight weeks follow-up
Change in strength of pinch force
Time frame: eight weeks after intervention, eight weeks follow-up
Change in walking speed
Time frame: eight weeks after intervention, eight weeks follow-up
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 10 May 2019.
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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.
Mi Mi Thet Mon Win, PhD student principal investigator
Graduate School of Health Sciences, Okayama University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises for diabetic peripheral neuropathy and Health education for diabetic foot care in people with Diabetic Peripheral Neuropathy, run by Okayama University at 1 site in Japan.
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 10 May 2019. 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 Japan. 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?
Change in Activities of daily living (ADLs) after intervention, at follow-up (time frame: eight weeks after intervention, eight weeks follow-up). The study lists 3 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 10 May 2019.