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

Diabete Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05711602
• Other study ID #: University_of_Jaén
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: April 21, 2023

Study information

• Verified date: September 2023
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 21, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult ALL
• Diabete Type 2
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Spain	U.E.D. Virgen de la Capilla	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamometer	Dynamometer will be employed to assess hand grip stregth.	Up to twelve weeks
Primary	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
Primary	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
Primary	TUG (Timed Up and Go test)	Is a simple test used to assess a person's mobility and physical function	Up to twelve weeks
Primary	chair sit and reach test	To test low back and hamstring flexibility.	Up to twelve weeks
Primary	back scratch test	To measure general shoulder range of motion.	Up to twelve weeks
Primary	height	The distance between the lowest and highest points of a person standing upright.	Up to twelve weeks
Primary	Yesavage Geriatric Depression Scale	Hetero-administered questionnaire used to detect depression in people over 65 years of age.	Up to twelve weeks
Primary	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
Primary	SF-12 (reduced version of The Health Survey Short Form-36)	Used extensively for assessing health-related quality of life.	Up to twelve weeks
Primary	BBS (the Berg Balance Scale)	Used to measure balance	Up to twelve weeks
Primary	PSS (Perceived Stress Scale )	Used to measure stress level	Up to twelve weeks
Primary	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