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

Study Overview
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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.

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

Conditions
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Adult ALL, Diabete Type 2

Intervention / Treatment
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* Other: Pilates


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates group<br>This group receives physical training based on pilates exercises | Other: Pilates<br>* 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.<br>|
| No Intervention: No intervention group<br>This group does not receive any treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamometer | Dynamometer will be employed to assess hand grip stregth. | Up to twelve weeks | 
| PSQI (Pittsburgh Sleep Quality Index) | A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality. | 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 | 
| Yesavage Geriatric Depression Scale | Hetero-administered questionnaire used to detect depression in people over 65 years of age. | Up to twelve weeks | 
| Hamilton Scale for Anxiety. | Hetero-administered scale used for the detection of anxiety, exploring the interruption of the emotional continum and subjective feelings of tension, restlessness or nervousness. | Up to twelve weeks | 
| SF-12 (reduced version of The Health Survey Short Form-36) | Used extensively for assessing health-related quality of life. | Up to twelve weeks | 
| BBS (the Berg Balance Scale) | Used to measure balance | Up to twelve weeks | 
| PSS (Perceived Stress Scale ) | Used to measure stress level | Up to twelve weeks | 
| Mini Nutritional Assessment (MNA) | The MNA is a validated instrument initially developed to assess nutritional status in elderly patients and is mainly indicated for research settings. | Up to twelve weeks |