Diabetic Patients With PolyneuropathyNCT00759265
Improving Mobility in Diabetic Patients Through Resistance Training
A study testing resistance training in people with Diabetic Patients With Polyneuropathy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Patients With Polyneuropathy
- What is being tested?
- resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2006to Jan 2011
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetic patients with polyneuropathy:
- valkscore >5;
- diabetic type 2;
- age >50 years
Who cannot join
- muscular related diseases;
- ischemia;
- amputation (except for toe amputation)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Hospital Maastricht
Maastricht, Limburg, 6229 HX
About this study
Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and will improve mobility and associated quality of life.
The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and muscle weakness, limited mobility and quality of life. Moreover, insight will be gained in optimizing training programmes for neuropathic patients.
- Conditions
- Diabetic Patients With Polyneuropathy
- Being tested
- resistance training
- Keywords
- Muscle strength, Physical activity, Mobility, Gait analysis
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingOther
During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks).
During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home.
| Study group | Role | What they receive |
|---|---|---|
| resistance training | Experimental | During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks).
During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home. Receives: Other: resistance training |
| control | No intervention | No intervention was prescribed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility
Measured: 0 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMay 2006
- Primary completionFeb 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Patients With PolyneuropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Teunis H IJzerman, MSc, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759265
- Sponsor's protocol ID
- 06-3-031
- Status last verified
- Jul 2010
- First submitted
- 24 Sep 2008
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Melai T, Schaper NC, Ijzerman TH, de Lange TL, Willems PJ, Lima Passos V, Lieverse AG, Meijer K, Savelberg HH. Lower leg muscle strengthening does not redistribute plantar load in diabetic polyneuropathy: a randomised controlled trial. J Foot Ankle Res. 2013 Oct 18;6(1):41. doi: 10.1186/1757-1146-6-41.
PubMed 24138784
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mobility in Diabetic Patients Through Resistance Training
- ClinicalTrials.gov ID
- NCT00759265
- Acronym / sponsor ID
- 06-3-031
- Conditions
- Diabetic Patients With Polyneuropathy
- Keywords
- Muscle strength, Physical activity, Mobility, Gait analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- May 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Sep 2008 (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.
Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and will improve mobility and associated quality of life.
The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and muscle weakness, limited mobility and quality of life. Moreover, insight will be gained in optimizing training programmes for neuropathic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance training | Experimental | Other: resistance trainingDuring 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home. |
| control | No intervention | –No intervention was prescribed |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diabetic patients with polyneuropathy:
- valkscore >5;
- diabetic type 2;
- age >50 years
Key exclusion criteria (3 listed)
- muscular related diseases;
- ischemia;
- amputation (except for toe amputation)
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 |
|---|---|---|
| resistance trainingDuring 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home. | Other | resistance training |
Primary outcome
Mobility
Time frame: 0 month, 3 months, 6 months, 12 months
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 7 Oct 2015.
- Derived from this study: PubMed 24138784Melai T, Schaper NC, Ijzerman TH, de Lange TL, Willems PJ, Lima Passos V, Lieverse AG, Meijer K, Savelberg HH. Lower leg muscle strengthening does not redistribute plantar load in diabetic polyneuropathy: a randomised controlled trial. J Foot Ankle Res. 2013 Oct 18;6(1):41. doi: 10.1186/1757-1146-6-41.
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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.
Teunis H IJzerman, MSc principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training in people with Diabetic Patients With Polyneuropathy, run by Maastricht University Medical Center at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 7 Oct 2015. 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 Netherlands. 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?
Mobility (time frame: 0 month, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00759265, which also lists 1 linked publication.
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 7 Oct 2015.