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The Physical and Mental Health of People With Type II Diabetes Mellitus.

Influence of the Pilates Method on the Physical and Mental Health of People With Type II Diabetes Mellitus.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05711602
Enrollment
104
Registered
2023-02-03
Start date
2024-01-09
Completion date
2024-04-21
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult ALL, Diabete Type 2

Brief summary

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.

Interventions

OTHERPilates

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.

Sponsors

University of Jaén
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes. All measurements given above will be made both to the control group and to the experimental group just prior to the start of the intervention, and immediately after and six months after the end of this period, and the results will be recorded in a data record

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of type 2 diabetes mellitus * Not participating in an exercise program * That they were able to carry out the different selected questionnaires.

Exclusion criteria

* Contraindications for performing physical tests * Illnesses that limit static and dynamic balance and physical activity * Central or peripheral vestibular or nervous disorders.

Design outcomes

Primary

MeasureTime frameDescription
DynamometerUp to twelve weeksDynamometer will be employed to assess hand grip stregth.
Blood Glucose ConcentrationUp to twelve weeksCapillary 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)Up to twelve weeksIs 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)Up to twelve weeksIs a simple test used to assess a person's mobility and physical function
Chair sit and reach testUp to twelve weeksTo test low back and hamstring flexibility.
Back scratch testUp to twelve weeksTo measure general shoulder range of motion.
HeightUp to twelve weeksThe distance between the lowest and highest points of a person standing upright.
BBS (the Berg Balance Scale)Up to twelve weeksUsed to measure balance

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026