Diabetes Mellitus, Type 2, Hypercholesterolemia, Hypertension, Obesity
Conditions
Brief summary
Thanks to improved healthcare, the life expectancy of people with ID is increasing and is approaching that of the general population. Several studies have shown that most cardiovascular disease (CVRF) risk factors are as common or even more common in people with ID than in the general population. The guidelines of the American College of Sport Medicine (ACSM) state that a resistance training (RT) programme can can effectively reduce CVRF if performed at a high intensity. A secondary benefit of RT is the increase in muscle strength and muscle mass that can reduce and can improve the ability to perform activities of daily living (ADL), also two common problems in people with ID.
Detailed description
This study has a repeated time series design with one study group. The study period will last one year and is divided into a 12-week baseline period, a 24-week intervention period (PRET programme), and a 12-week follow-up period. The PRET programme will take 24 weeks and consists of two sessions per week, with at least 48 hours between the sessions. The intervention will be led by experienced physiotherapists and physical activity instructors employed by the care providers. All instructors take part in a training prior to the study. In this training, the intervention protocol and exercises will be discussed and practiced ensuring that the intervention is delivered according to the protocol. Every session consists of seven exercises (RESID) to train all large muscle groups. The programme is in accordance with the ACSM guidelines and characterised by four mesocycles. Each mesocycle consists of six weeks of training. After each mesocycle the training intensity will increase gradually, and within each mesocycle the weights will be adjusted in a way that the intensity remains equal. Training intensity will be measured by the percentage of the heaviest load one can lift for one repetition (% of 1RM). In the first mesocycle, participants are introduced to the resistance exercises and familiarised to the training protocol. They will learn to perform the exercises safely and with good posture. During mesocycles 2, 3, and 4, the number of repetitions will be gradually decreased while the training intensity will be gradually increased until vigorous intensity is reached in the fourth mesocycle (80% of 1RM). The resting time between sets will depend on the training intensity and varies between 30 seconds and 2 minutes. The instructors will register attendance, training intensity, performed number of sets and repetitions, and the weights used for each exercise in a log.
Interventions
A 24-week progressive strength training programme (PRET). Divided into 4 mesocycles in which the intensity of training is built up from 60% 1RM- 80% 1RM. Training is carried out twice a week under the guidance of a physiotherapist or exercise instructor.
Sponsors
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* being 18 years or older; * living in a residential facility or receiving care from one of the participating care providers; * diagnosed with mild (IQ = 50-69) or moderate (IQ = 35-49) ID; * diagnosed with metabolic syndrome, or at least two of the following CVRF: hypertension, hypercholesterolemia, diabetes mellitus type 2, or obesity. * participants must be able to walk independently and able to follow instructions on posture and performance for good execution of the exercises
Exclusion criteria
not able to follow instructions or physical limitations interfering with participation in training programme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Haemoglobin | through study completion, an average of 1 year | mmol/mol, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC |
| Systolic blood pressure | through study completion, an average of 1 year | mm/Hg, Blood pressure is measured with a digital blood pressure device |
| LDL cholesterol | through study completion, an average of 1 year | mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC |
| Waist-hip ratio | through study completion, an average of 1 year | cm, Waist-hip ratio is calculated after measuring waist circumference and hip circumference with a flexible tape measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | through study completion, an average of 1 year | kg, Muscle strength is measured with handgrip strength, 30 second chair stand and 5 times chair stand |
| Muscle mass | through study completion, an average of 1 year | kg, Muscle mass is measured with a bio electrical impedance device |
| HDL cholesterol | through study completion, an average of 1 year | mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC |
| Fall incidents | through study completion, an average of 1 year | Falls are reported during baseline and follow up with a calandar filled in by proxy |
| ABC questionnaire | through study completion, an average of 1 year | Behavioural issues is measured with the ABC questionnaire, which is filled in by proxy |
| (I)ADL questionnaire | through study completion, an average of 1 year | (I)ADL is measured with a questionnaire, which is filled in by proxy |
| Total cholesterol | through study completion, an average of 1 year | mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC |
| Triglycerides | through study completion, an average of 1 year | mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC |
| Glucose | through study completion, an average of 1 year | mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC |
Countries
Netherlands
Outcome results
None listed