NCT Number: NCT06579898
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Amarant, Tilburg, North Brabant, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
not able to follow instructions or physical limitations interfering with participation in training programme
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.
Time frame: through study completion, an average of 1 year
mmol/mol, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Time frame: through study completion, an average of 1 year
mm/Hg, Blood pressure is measured with a digital blood pressure device
Time frame: through study completion, an average of 1 year
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Time frame: 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.
Time frame: through study completion, an average of 1 year
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Time frame: through study completion, an average of 1 year
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Time frame: through study completion, an average of 1 year
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Time frame: through study completion, an average of 1 year
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Time frame: 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
Time frame: through study completion, an average of 1 year
kg, Muscle mass is measured with a bio electrical impedance device
Time frame: through study completion, an average of 1 year
(I)ADL is measured with a questionnaire, which is filled in by proxy
Time frame: through study completion, an average of 1 year
Falls are reported during baseline and follow up with a calandar filled in by proxy
Time frame: through study completion, an average of 1 year
Behavioural issues is measured with the ABC questionnaire, which is filled in by proxy
Erasmus Medical Center
Other
The Effect of Progressive Resistance Exercise Training (PRET) on Cardiovascular Risk Factors in Adults With ID.
Acronym: PRET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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