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The Effect of Progressive Resistance Exercise Training (PRET) on CVRF in Adults With ID.

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Erasmus University

Status

Completed

Conditions

Hypertension
Hypercholesterolemia
Obesity
Diabetes Mellitus, Type 2

Treatments

Other: Progressive resistance exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT06579898
NTR NL8382

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

PRET
Experimental group
Description:
All participants participate in a progressive resistance exercise training programme for 24 weeks.
Treatment:
Other: Progressive resistance exercise training

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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