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

Not Applicable

Completed

• Conditions: Diabete Type 2; Adult ALL
• Interventions: Other: Pilates

• Registration Number: NCT05711602
• Lead Sponsor: University of Jaén

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.

Study Timeline

• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-03
• Study Start: 2024-01-09
• Primary Completion: 2024-01-20
• Study Completion: 2024-04-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilates group	Pilates	This group receives physical training based on pilates exercises

Primary Outcome Measures

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

Trial Locations

Locations (1)

U.E.D. Virgen de la Capilla; 🇪🇸 Jaén, Spain