Skip to main content
OpenTrials
Completed

NCT Number: NCT05711602

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adult ALL Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Nutritional and Metabolic Diseases Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U.E.D. Virgen de la Capilla

Jaén, 23004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates

Other

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.

Primary outcomes

  1. Dynamometer

    Time frame: Up to twelve weeks

    Dynamometer will be employed to assess hand grip stregth.

  2. 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.

  3. 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.

  4. 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

  5. Chair sit and reach test

    Time frame: Up to twelve weeks

    To test low back and hamstring flexibility.

  6. Back scratch test

    Time frame: Up to twelve weeks

    To measure general shoulder range of motion.

  7. Height

    Time frame: Up to twelve weeks

    The distance between the lowest and highest points of a person standing upright.

  8. BBS (the Berg Balance Scale)

    Time frame: Up to twelve weeks

    Used to measure balance

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.