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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Muscle disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Muscle strength in the leg: the strength of the plantar- and dorsalfelxors and
for the knee and hip extensors and flexors will be determined.
Fysical activity: during one week, the daily activity will be determined using
an accelerometer.
Mobility: this will be determined using a questionnaire and a 6 minutes walking
test.
Gait analysis: walking patterns will be analysed using video analysis and the
force plait.
Secondary outcome
Quality of life wil be measured using a questionnaire.
Difficulty in Activities of daily living Tasks (DAT) will be determined using
EMG during a 6 minutes walking test.
Background 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. 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.
Study objective
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
It's a prospective randomized clinical trial.
Intervention
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 burden and risks
The subjects who will participate in this study will run no more risks then
they do in their daily living.
Universiteitssingel 50
6229 ER Maastricht
Nederland
Universiteitssingel 50
6229 ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
diabetic patients with polyneuropathy: valkscore >5; diabetic type 2; age >50 years;, 20diabetic patients without polyneuropathie: diabetic type 2; age >50 years; 20healthy elderly subjects: age >50 years, 20
Exclusion criteria
muscular related diseases
ischemia
amputation (except for toe amputation)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11910.068.06 |