Adult ALLNCT05711602
The Physical and Mental Health of People With Type II Diabetes Mellitus.
A study testing Pilates in people with Adult ALL and Diabete Type 2, run by University of Jaén at 1 site in Spain.
Trial summary
To analyze the effects of a Pilates exercise program on physical and mental health in people with type II diabetes mellitus. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Adult ALL, Diabete Type 2
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2024to 21 Apr 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus
- Not participating in an exercise program
- That they were able to carry out the different selected questionnaires.
Who cannot join
- Contraindications for performing physical tests
- Illnesses that limit static and dynamic balance and physical activity
- Central or peripheral vestibular or nervous disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Pilates Method on the Physical and Mental Health of People With Type II Diabetes Mellitus.
To analyze the effects of a Pilates exercise program on physical and mental health in people with type II diabetes mellitus.
Read the detailed description
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
- Conditions
- Adult ALL, Diabete Type 2
- Being tested
- Pilates
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
raining based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty.
| Study group | Role | What they receive |
|---|---|---|
| Pilates group | Experimental | This group receives physical training based on pilates exercises Receives: Other: Pilates |
| No intervention group | No intervention | This group does not receive any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamometer
Dynamometer will be employed to assess hand grip stregth.
Measured: Up to twelve weeks
Blood Glucose Concentration
Capillary blood glucose monitoring is the primary tool for monitoring blood glucose levels at any time of day. It involves a small fingertip prick to check blood sugar levels at a specific time of day. This procedure requires a pen containing a fine needle or lancet, test strips, and a glucose meter (glucometer). Reference values vary depending on the time of sample collection: preprandial 80-130 mg/dL and postprandial <180 mg/dL. In Spain, this measurement is performed among older adults with type 2 diabetes mellitus.
Measured: Up to twelve weeks
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Measured: Up to twelve weeks
TUG (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function
Measured: Up to twelve weeks
Chair sit and reach test
To test low back and hamstring flexibility.
Measured: Up to twelve weeks
Back scratch test
To measure general shoulder range of motion.
Measured: Up to twelve weeks
Height
The distance between the lowest and highest points of a person standing upright.
Measured: Up to twelve weeks
BBS (the Berg Balance Scale)
Used to measure balance
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start9 Jan 2024
- Primary completion20 Jan 2024
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ALLStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711602
- Sponsor's protocol ID
- University_of_Jaén
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Pilates Method on the Physical and Mental Health of People With Type II Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT05711602
- Acronym / sponsor ID
- University_of_Jaén
- Conditions
- Adult ALL, Diabete Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 3 Feb 2023 (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.
To analyze the effects of a Pilates exercise program on physical and mental health in people with type II diabetes mellitus.
Detailed description
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pilates group | Experimental | Other: PilatesThis group receives physical training based on pilates exercises |
| No intervention group | No intervention | –This group does not receive any treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of type 2 diabetes mellitus
- Not participating in an exercise program
- That they were able to carry out the different selected questionnaires.
Key exclusion criteria (3 listed)
- Contraindications for performing physical tests
- Illnesses that limit static and dynamic balance and physical activity
- Central or peripheral vestibular or nervous disorders.
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 |
|---|---|---|
| Pilatesraining based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty. | Other | Pilates group |
Primary outcome
Dynamometer
Time frame: Up to twelve weeks
Dynamometer will be employed to assess hand grip stregth.
Blood Glucose Concentration
Time frame: Up to twelve weeks
Capillary blood glucose monitoring is the primary tool for monitoring blood glucose levels at any time of day. It involves a small fingertip prick to check blood sugar levels at a specific time of day. This procedure requires a pen containing a fine needle or lancet, test strips, and a glucose meter (glucometer). Reference values vary depending on the time of sample collection: preprandial 80-130 mg/dL and postprandial <180 mg/dL. In Spain, this measurement is performed among older adults with type 2 diabetes mellitus.
BMI (Body Mass Index)
Time frame: Up to twelve weeks
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
TUG (Timed Up and Go test)
Time frame: Up to twelve weeks
Is a simple test used to assess a person's mobility and physical function
Chair sit and reach test
Time frame: Up to twelve weeks
To test low back and hamstring flexibility.
Back scratch test
Time frame: Up to twelve weeks
To measure general shoulder range of motion.
Height
Time frame: Up to twelve weeks
The distance between the lowest and highest points of a person standing upright.
BBS (the Berg Balance Scale)
Time frame: Up to twelve weeks
Used to measure balance
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 19 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates in people with Adult ALL and Diabete Type 2, run by University of Jaén at 1 site in Spain.
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 3 inclusion and 3 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Dynamometer (time frame: Up to twelve weeks). The study lists 8 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 19 Mar 2025.