To investigate whether an exercise-program that takes the patient*s level of exercise-self-efficacy into account, added to regular care, is more effective compared to regular care in increase the patients level of physical activity, improve…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical activity, cardiovascular risk factors and health status.
Secondary outcome
Patient satisfaction, diabetes self-efficacy, depressive symptoms and quality
of sleep.
Background summary
Sufficient exercise is important for people with Type 2 Diabetes Mellitus, as
it can help to prevent or delay future health problems. Although the knowledge
about the effects of physical activity and the number of diabetes-exercise
programs is increasing, still a substantial number of people with type 2
Diabetes Mellitus do not exercise enough. Therefore, we have developed a new
diabetes-exercise program that takes into account the patients* level of
exercise self-efficacy (the confidence that the patients has regarding his/her
ability to independently increase their level of physical activity).
Study objective
To investigate whether an exercise-program that takes the patient*s level of
exercise-self-efficacy into account, added to regular care, is more effective
compared to regular care in increase the patients level of physical activity,
improve cardiovascular risk factors and the health status of inactive people
with type 2 Diabetes Mellitus
Study design
Non-randomised controlled trial. Participants of the intervention are allocated
to the intervention- or control group based on their exercise self-efficacy
score. Participants with a high score are allocated to an advice program,
participants with a low score to an intensive program. The duration of the
intervention is 36 weeks. Participants of the control group receive regular
care.
Intervention
The intervention consists of an intensive program and an advice program.
Patients with a low self-reported level of exercise self-efficacy are allocated
to the intensive program. The intensive program consists of an intake, 24
physiotherapist guided group trainings (1 hour each) and four individual
advise-consults with the physiotherapist. Patients with a high
exercise-self-efficacy score are allocated to the advice program. The advice
program consists of an intake and four individual advise-consults with the
physiotherapist. Both programs last 36 weeks, and aim to increase the
exercise-level of the participants to at least 3 hours a week.
Study burden and risks
All patients receive regular diabetes care. People in the intervention are
participating in a 36 weeks exercise program with the aim to exercise at least
3 hours a week. They are stimulated to keep exercising after the program has
ended. Patients in the intervention receive 5 sets of questionnaires; patients
in the control group receive 3 questionnaire-sets (20-30
minutes/questionnaire). There are no additional invasive measurements as they
are part of regular diabetes care. The risks of the exercise program are
limited as a result of an easy accessible program that is guided by
professionals. An increase of physical activity can have positive effects on
health such as a better physical fitness and improvement of several
psychological factors.
Warandelaan 2
5037 AB Tilburg
NL
Warandelaan 2
5037 AB Tilburg
NL
Listed location countries
Age
Inclusion criteria
- The patient is diagnosed with type 2 Diabetes Mellitus
- The patient exercises less than advised in the Dutch Guidelines for Physical Activity
(i.e.at least 30 minutes/day, 5 days/week).
- The patient*s BMI is over 25kg/m2
- The patient is born between 1930 and 1992.
Exclusion criteria
- De patient is suffering from a serious complication of type 2 Diabetes Mellitus or other disabling co-morbidity: e.g. unstable angina pectoris, heart failure, very high blood pressure, cerebrovascular accident, serious neuropathy, kidney failure, diabetic foot ulcer(s), proliferative retinopathy, a serious form of cancer, orthopaedic constraints, serious exertion hypertension, unstable coronary ischemia.
- The patient recently participated in an exercise program on an indication other than Type 2 Diabetes Mellitus
-Results of the cycle ergometry debar participation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33834.008.10 |
| OMON | NL-OMON24343 |