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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Diabetes Mellitus, Type 2; Hypercholesterolemia
• Intervention / Treatment: Other: Progressive resistance exercise training

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Brabant
    • Tilburg, Brabant, Netherlands, 5037LD
      • Amarant
  • Zuid-holland
    • Huis Ter Heide, Zuid-holland, Netherlands, 3712XA
      • Abrona
    • Zoetermeer, Zuid-holland, Netherlands, 2719EK
      • Ipse de Bruggen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRET; All participants participate in a progressive resistance exercise training programme for 24 weeks.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC	through study completion, an average of 1 year
HDL cholesterol	mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC	through study completion, an average of 1 year
Total cholesterol	mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC	through study completion, an average of 1 year
Glucose	mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC	through study completion, an average of 1 year
Muscle strength	kg, Muscle strength is measured with handgrip strength, 30 second chair stand and 5 times chair stand	through study completion, an average of 1 year
Muscle mass	kg, Muscle mass is measured with a bio electrical impedance device	through study completion, an average of 1 year
(I)ADL questionnaire	(I)ADL is measured with a questionnaire, which is filled in by proxy	through study completion, an average of 1 year
Fall incidents	Falls are reported during baseline and follow up with a calandar filled in by proxy	through study completion, an average of 1 year
ABC questionnaire	Behavioural issues is measured with the ABC questionnaire, which is filled in by proxy	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Alyt Oppewal, Dr, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Diabetes Mellitus, Type 2; Hypercholesterolemia
• Other Study ID Numbers: NTR NL8382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol has been published. Further information can be requested.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No