Diabetes Mellitus, Type 2PRETNCT06579898
The Effect of Progressive Resistance Exercise Training (PRET) on CVRF in Adults With ID.
A study testing Progressive resistance exercise training in people with Diabetes Mellitus, Type 2 and Hypertension, run by Erasmus Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia
- What is being tested?
- Progressive resistance exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Dec 2021to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not able to follow instructions or physical limitations interfering with participation in training programme
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Abrona
Huis Ter Heide, South Holland, 3712XA
Amarant
Tilburg, North Brabant, 5037LD
Ipse de Bruggen
Zoetermeer, South Holland, 2719EK
About this study
Official title: 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.
Read the 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
- Being tested
- Progressive resistance exercise training
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PRET | Experimental | All participants participate in a progressive resistance exercise training programme for 24 weeks. Receives: Other: Progressive resistance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Haemoglobin
mmol/mol, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Measured: through study completion, an average of 1 year
Systolic blood pressure
mm/Hg, Blood pressure is measured with a digital blood pressure device
Measured: 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
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Triglycerides
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Glucose
mmol/L, Outcome is measured with blood samples and analysed in a laboratory of ErasmusMC
Measured: 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
Measured: through study completion, an average of 1 year
Muscle mass
kg, Muscle mass is measured with a bio electrical impedance device
Measured: through study completion, an average of 1 year
(I)ADL questionnaire
(I)ADL is measured with a questionnaire, which is filled in by proxy
Measured: 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
Measured: through study completion, an average of 1 year
ABC questionnaire
Behavioural issues is measured with the ABC questionnaire, which is filled in by proxy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Dec 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten de Oude MSc, Erasmus Medical Center
- Investigators
- Alyt Oppewal, Dr, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579898
- Sponsor's protocol ID
- NTR NL8382
- Acronym
- PRET
- Status last verified
- Aug 2024
- First submitted
- 7 Mar 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol has been published. Further information can be requested.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Resistance Exercise Training (PRET) on Cardiovascular Risk Factors in Adults With ID.
- ClinicalTrials.gov ID
- NCT06579898
- Acronym / sponsor ID
- PRET / NTR NL8382
- Conditions
- Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRET | Experimental | Other: Progressive resistance exercise trainingAll participants participate in a progressive resistance exercise training programme for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- not able to follow instructions or physical limitations interfering with participation in training programme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance exercise trainingA 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. | Other | PRET |
Primary outcome
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
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
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
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.
9 secondary outcomes
Triglycerides
Time frame: through study completion, an average of 1 year
HDL cholesterol
Time frame: through study completion, an average of 1 year
Total cholesterol
Time frame: through study completion, an average of 1 year
Glucose
Time frame: through study completion, an average of 1 year
Muscle strength
Time frame: through study completion, an average of 1 year
Muscle mass
Time frame: through study completion, an average of 1 year
(I)ADL questionnaire
Time frame: through study completion, an average of 1 year
Fall incidents
Time frame: through study completion, an average of 1 year
ABC questionnaire
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: Yes. Study protocol has been published. Further information can be requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyt Oppewal, Dr principal investigator
Erasmus Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance exercise training in people with Diabetes Mellitus, Type 2 and Hypertension, run by Erasmus Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Haemoglobin (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.