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.

To analyze the effects of a Pilates exercise program on physical and mental health in people with type II diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Adult ALL; Diabete Type 2
• Intervention / Treatment: Other: Pilates

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Jaén, Spain, 23004
    • U.E.D. Virgen de la Capilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates group; This group receives physical training based on pilates exercises	Other: Pilates; 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.
No Intervention: No intervention group; This group does not receive any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to twelve weeks
Dynamometer	Dynamometer will be employed to assess hand grip stregth.	Up to twelve weeks
TUG (Timed Up and Go test)	Is a simple test used to assess a person's mobility and physical function	Up to twelve weeks
BBS (the Berg Balance Scale)	Used to measure balance	Up to twelve weeks
Chair sit and reach test	To test low back and hamstring flexibility.	Up to twelve weeks
Back scratch test	To measure general shoulder range of motion.	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.	Up to twelve weeks
Height	The distance between the lowest and highest points of a person standing upright.	Up to twelve weeks

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): April 21, 2024

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: University_of_Jaén

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No