Clinical trial NCT06579898: The Effect of Progressive Resistance Exercise Training (PRET) on CVRF in Adults With ID.
Official title: The Effect of Progressive Resistance Exercise Training (PRET) on Cardiovascular Risk Factors in Adults With ID.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Hypercholesterolemia
Obesity
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycated Haemoglobin
timeFrame: through study completion, an average of 1 year
measure: Systolic blood pressure
timeFrame: through study completion, an average of 1 year
measure: LDL cholesterol
timeFrame: through study completion, an average of 1 year
measure: Waist-hip ratio
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Triglycerides
timeFrame: through study completion, an average of 1 year
measure: HDL cholesterol
timeFrame: through study completion, an average of 1 year
measure: Total cholesterol
timeFrame: through study completion, an average of 1 year
measure: Glucose
timeFrame: through study completion, an average of 1 year
measure: Muscle strength
timeFrame: through study completion, an average of 1 year
measure: Muscle mass
timeFrame: through study completion, an average of 1 year
measure: (I)ADL questionnaire
timeFrame: through study completion, an average of 1 year
measure: Fall incidents
timeFrame: through study completion, an average of 1 year
measure: ABC questionnaire
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Amarant
state: Brabant
city: Huis Ter Heide
country: Netherlands
facility: Abrona
state: Zuid-holland
city: Zoetermeer
country: Netherlands
facility: Ipse de Bruggen
state: Zuid-holland
Study officials:
affiliation: Erasmus Medical Center
name: Alyt Oppewal, Dr
role: PRINCIPAL_INVESTIGATOR
References: