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

NCT05711602 | Completed

• 1 other identifier: University_of_Jaén
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adult ALL; Diabete Type 2

Outcome Measures

Primary Outcomes (8)

• Dynamometer

  Dynamometer will be employed to assess hand grip stregth.

  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

• 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

• TUG (Timed Up and Go test)

  Is a simple test used to assess a person's mobility and physical function

  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

• Height

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

  Up to twelve weeks

• BBS (the Berg Balance Scale)

  Used to measure balance

  Up to twelve weeks

Study Arms (2)

Pilates group

EXPERIMENTAL

This group receives physical training based on pilates exercises

Other: Pilates

No intervention group

NO INTERVENTION

This group does not receive any treatment

Interventions

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.

Pilates group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

U.E.D. Virgen de la Capilla

Jaén, 23004, Spain

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Diabetes Mellitus, Type 2

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: February 3, 2023
• Study Start: January 9, 2024
• Primary Completion: January 20, 2024
• Study Completion: April 21, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

ES (1)