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

NCT06579898 | Completed

• 1 other identifier: NTR NL8382
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Hypercholesterolemia; Obesity

Outcome Measures

Primary Outcomes (4)

• Glycated Haemoglobin

  mmol/mol, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC

  through study completion, an average of 1 year

• Systolic blood pressure

  mm/Hg, Blood pressure is measured with a digital blood pressure device

  through study completion, an average of 1 year

• LDL cholesterol

  mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC

  through study completion, an average of 1 year

• Waist-hip ratio

  cm, Waist-hip ratio is calculated after measuring waist circumference and hip circumference with a flexible tape measure.

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Triglycerides

  through study completion, an average of 1 year

• HDL cholesterol

  through study completion, an average of 1 year

• Total cholesterol

  through study completion, an average of 1 year

• Glucose

  through study completion, an average of 1 year

• Muscle strength

  through study completion, an average of 1 year

Study Arms (1)

PRET

EXPERIMENTAL

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

Other: Progressive resistance exercise training

Interventions

Progressive resistance exercise training 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.

PRET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• not able to follow instructions or physical limitations interfering with participation in training programme

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

Amarant

Tilburg, North Brabant, 5037LD, Netherlands

Location

Abrona

Huis Ter Heide, South Holland, 3712XA, Netherlands

Location

Ipse de Bruggen

Zoetermeer, South Holland, 2719EK, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Hypercholesterolemia; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alyt Oppewal, Dr

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: August 30, 2024
• Study Start: December 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study Protocol is available Elbers RG, de Oude KI, Kastanidis T, Maes-Festen DAM, Oppewal A. The Effect of Progressive Resistance Exercise Training on Cardiovascular Risk Factors in People with Intellectual Disabilities: A Study Protocol. Int J Environ Res Public Health. 2022 Dec 8;19(24):16438. doi: 10.3390/ijerph192416438. PMID: 36554319; PMCID: PMC9778210.
• Access Criteria: Open access

Locations

NL (3)