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

NCT ID: NCT06579898

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-07-01

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Hypercholesterolemia; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRET

All participants participate in a progressive resistance exercise training programme for 24 weeks.

Group Type: EXPERIMENTAL

Progressive resistance exercise training

Intervention Type: OTHER

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.

Interventions

Progressive resistance exercise training

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kirsten de Oude MSc

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alyt Oppewal, Dr

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Amarant

Tilburg, North Brabant, Netherlands

Abrona

Huis Ter Heide, South Holland, Netherlands

Ipse de Bruggen

Zoetermeer, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

NTR NL8382

Identifier Type: -

Identifier Source: org_study_id