The Physical and Mental Health of People With Type II Diabetes Mellitus.
Primary Purpose
Adult ALL, Diabete Type 2
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pilates
Sponsored by

About this trial
This is an interventional treatment trial for Adult ALL
Eligibility Criteria
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.
Sites / Locations
- U.E.D. Virgen de la Capilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pilates group
No intervention group
Arm Description
This group receives physical training based on pilates exercises
This group does not receive any treatment
Outcomes
Primary Outcome Measures
Dynamometer
Dynamometer will be employed to assess hand grip stregth.
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
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.
TUG (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function
chair sit and reach test
To test low back and hamstring flexibility.
back scratch test
To measure general shoulder range of motion.
height
The distance between the lowest and highest points of a person standing upright.
Yesavage Geriatric Depression Scale
Hetero-administered questionnaire used to detect depression in people over 65 years of age.
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.
SF-12 (reduced version of The Health Survey Short Form-36)
Used extensively for assessing health-related quality of life.
BBS (the Berg Balance Scale)
Used to measure balance
PSS (Perceived Stress Scale )
Used to measure stress level
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05711602
First Posted
January 21, 2023
Last Updated
September 14, 2023
Sponsor
University of Jaén
1. Study Identification
Unique Protocol Identification Number
NCT05711602
Brief Title
The Physical and Mental Health of People With Type II Diabetes Mellitus.
Official Title
Influence of the Pilates Method on the Physical and Mental Health of People With Type II Diabetes Mellitus.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
April 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult ALL, Diabete Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilates group
Arm Type
Experimental
Arm Description
This group receives physical training based on pilates exercises
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
This group does not receive any treatment
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dynamometer
Description
Dynamometer will be employed to assess hand grip stregth.
Time Frame
Up to twelve weeks
Title
PSQI (Pittsburgh Sleep Quality Index)
Description
A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
Time Frame
Up to twelve weeks
Title
BMI (Body Mass Index)
Description
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Time Frame
Up to twelve weeks
Title
TUG (Timed Up and Go test)
Description
Is a simple test used to assess a person's mobility and physical function
Time Frame
Up to twelve weeks
Title
chair sit and reach test
Description
To test low back and hamstring flexibility.
Time Frame
Up to twelve weeks
Title
back scratch test
Description
To measure general shoulder range of motion.
Time Frame
Up to twelve weeks
Title
height
Description
The distance between the lowest and highest points of a person standing upright.
Time Frame
Up to twelve weeks
Title
Yesavage Geriatric Depression Scale
Description
Hetero-administered questionnaire used to detect depression in people over 65 years of age.
Time Frame
Up to twelve weeks
Title
Hamilton Scale for Anxiety.
Description
Hetero-administered scale used for the detection of anxiety, exploring the interruption of the emotional continum and subjective feelings of tension, restlessness or nervousness.
Time Frame
Up to twelve weeks
Title
SF-12 (reduced version of The Health Survey Short Form-36)
Description
Used extensively for assessing health-related quality of life.
Time Frame
Up to twelve weeks
Title
BBS (the Berg Balance Scale)
Description
Used to measure balance
Time Frame
Up to twelve weeks
Title
PSS (Perceived Stress Scale )
Description
Used to measure stress level
Time Frame
Up to twelve weeks
Title
Mini Nutritional Assessment (MNA)
Description
The MNA is a validated instrument initially developed to assess nutritional status in elderly patients and is mainly indicated for research settings.
Time Frame
Up to twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
U.E.D. Virgen de la Capilla
City
Jaén
ZIP/Postal Code
23004
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
The Physical and Mental Health of People With Type II Diabetes Mellitus.
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