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

NCT ID: NCT05711602

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2024-04-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Adult ALL Diabete Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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

Study Groups

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Pilates group

This group receives physical training based on pilates exercises

Group Type EXPERIMENTAL

Pilates

Intervention Type 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.

No intervention group

This group does not receive any treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jaén

OTHER

Sponsor Role lead

Responsible Party

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Agustín Aibar Almazán

Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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U.E.D. Virgen de la Capilla

Jaén, , Spain

Site Status

Countries

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Spain

Other Identifiers

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University_of_Jaén

Identifier Type: -

Identifier Source: org_study_id

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