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

August 28, 2024 updated by: Kirsten de Oude MSc, Erasmus Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycated Haemoglobin
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
mm/Hg, Blood pressure is measured with a digital blood pressure device
through study completion, an average of 1 year
LDL cholesterol
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Triglycerides
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
through study completion, an average of 1 year
Glucose
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
kg, Muscle mass is measured with a bio electrical impedance device
through study completion, an average of 1 year
(I)ADL questionnaire
Time Frame: through study completion, an average of 1 year
(I)ADL is measured with a questionnaire, which is filled in by proxy
through study completion, an average of 1 year
Fall incidents
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alyt Oppewal, Dr, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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