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Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

65 Years - 105 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being over the age of 65 Getting a diagnosis of sarcopenia To be able to walk at least 10 meters independently in public Getting a score of 4 and above from the clock drawing test Volunteer individuals Exclusion Criteria: Having a neurological disease Having an uncontrollable cardiopulmonary disease Acute illness that will prevent him/her from understanding and performing the exercises to be performed status or the presence of significant cognitive impairment Providing continuity for less than 80% of the exercise program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group 1

    Group 2

    Arm Description

    Participants in this group will receive holistic-based group exercise program. All evaluations in this group will be done in the form of before and after. The exercise program will be applied for 12 weeks, 3 days a week.

    Participants in this group will continue their routine habits and nutrition programs. All assessments in this group will be done in the form of before and after.

    Outcomes

    Primary Outcome Measures

    Muscle Mass
    Muscle ultrasound (US) is a feasible and practical tool to predict sarcopenia. It provides scope for the efficient assessment of muscle quality whilst providing insight into the pathophysiology of sarcopenia in addition to the diagnosis of low muscle mass. US has distinct advantages over other available modalities for muscle mass because the tool allows for separate measurements of individual muscle groups in addition to being safe and portable.
    The Timed Up&Go Test
    It is a balance test used in the evaluation of functional mobility in the elderly. In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The elapsed time in this sequence is recorded in seconds. Patients wear their regular footwear and can use a walking aid, if needed.
    Short Physical Performance Battery (SPPB)
    The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). A patient's score below 10 is the inclusion criterion for sarcopenia.

    Secondary Outcome Measures

    SARC-F Questionnaire
    There are 5 SARC-F components: Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.
    Charlson Comorbidity Index
    The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
    30-Second Chair Stand Test
    The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults. In the middle part of the chair, the person's back is upright, his feet are pressed to the floor and his arms it is ensured that he sits diagonally in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While the person is in this position, he starts the test with the start command and does it as fully as he can for 30 seconds he takes off; the exact number of departures he has made during 30 seconds constitutes the person's score. Scores less than 10 indicate poor muscle endurance.
    Hand Grip Strength
    It is a method that provides reliable information about upper extremity muscle strength. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength. It is most useful when multiple measurements are taken over time to track performance.
    Berg Balance Test
    The BBS consists of 14 different items that evaluate sitting, standing, and dynamic balance in a hierarchical manner and are assigned scores of 0 to 4, with 0 indicating that an individual is unable to complete the task entirely. The BBS comprises the following tasks: sit to stand; standing without support; sitting without support; stand to sit; transfers; standing with eyes closed; the Romberg test with eyes open; functional reach in standing; picking up something off the floor; turning and looking behind; a 360° turn to the right and left; toe touches to a stool; the sharpened Romberg test; and single-leg stance. A high score indicates good balance.
    Depression
    The 15-item geriatric depression scale (GDS-15) is a short form of GDS and is used to screen, diagnose, and evaluate depression in elderly individuals. The cut-off point of the scale is 7 points and above.
    Mini Nutritional Assessment (MNA)
    The Mini Nutritional Assessment (MNA) has recently been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min. In the test with a total score of 30, below 17 points is considered as significant malnutrition.

    Full Information

    First Posted
    January 20, 2023
    Last Updated
    January 20, 2023
    Sponsor
    Ondokuz Mayıs University
    Collaborators
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05705934
    Brief Title
    Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia
    Official Title
    Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 30, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    November 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ondokuz Mayıs University
    Collaborators
    Ankara Yildirim Beyazıt University

    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
    A decrease in muscle mass and function can cause the development of many chronic diseases, including sarcopenia. It has been reported that the best intervention for sarcopenia is exercise. Despite this, the optimal type of exercise for sarcopenia has not yet been determined. Although the holistic approach is used in the literature in the elderly population, it is noticeable that it does not find much space for itself in this patient group. In this study, it was aimed to examine the effects of holistic approach-based exercise program on individuals with sarcopenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive holistic-based group exercise program. All evaluations in this group will be done in the form of before and after. The exercise program will be applied for 12 weeks, 3 days a week.
    Arm Title
    Group 2
    Arm Type
    No Intervention
    Arm Description
    Participants in this group will continue their routine habits and nutrition programs. All assessments in this group will be done in the form of before and after.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Each session of the exercise program will last 50 minutes and will consist of 4 stages. At these stages, it is aimed to work the social, physical, spiritual and mental parameters of the holistic approach.
    Primary Outcome Measure Information:
    Title
    Muscle Mass
    Description
    Muscle ultrasound (US) is a feasible and practical tool to predict sarcopenia. It provides scope for the efficient assessment of muscle quality whilst providing insight into the pathophysiology of sarcopenia in addition to the diagnosis of low muscle mass. US has distinct advantages over other available modalities for muscle mass because the tool allows for separate measurements of individual muscle groups in addition to being safe and portable.
    Time Frame
    Change from baseline at 12 weeks
    Title
    The Timed Up&Go Test
    Description
    It is a balance test used in the evaluation of functional mobility in the elderly. In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The elapsed time in this sequence is recorded in seconds. Patients wear their regular footwear and can use a walking aid, if needed.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Short Physical Performance Battery (SPPB)
    Description
    The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). A patient's score below 10 is the inclusion criterion for sarcopenia.
    Time Frame
    Change from baseline at 12 weeks
    Secondary Outcome Measure Information:
    Title
    SARC-F Questionnaire
    Description
    There are 5 SARC-F components: Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Charlson Comorbidity Index
    Description
    The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
    Time Frame
    Change from baseline at 12 weeks
    Title
    30-Second Chair Stand Test
    Description
    The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults. In the middle part of the chair, the person's back is upright, his feet are pressed to the floor and his arms it is ensured that he sits diagonally in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While the person is in this position, he starts the test with the start command and does it as fully as he can for 30 seconds he takes off; the exact number of departures he has made during 30 seconds constitutes the person's score. Scores less than 10 indicate poor muscle endurance.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Hand Grip Strength
    Description
    It is a method that provides reliable information about upper extremity muscle strength. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength. It is most useful when multiple measurements are taken over time to track performance.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Berg Balance Test
    Description
    The BBS consists of 14 different items that evaluate sitting, standing, and dynamic balance in a hierarchical manner and are assigned scores of 0 to 4, with 0 indicating that an individual is unable to complete the task entirely. The BBS comprises the following tasks: sit to stand; standing without support; sitting without support; stand to sit; transfers; standing with eyes closed; the Romberg test with eyes open; functional reach in standing; picking up something off the floor; turning and looking behind; a 360° turn to the right and left; toe touches to a stool; the sharpened Romberg test; and single-leg stance. A high score indicates good balance.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Depression
    Description
    The 15-item geriatric depression scale (GDS-15) is a short form of GDS and is used to screen, diagnose, and evaluate depression in elderly individuals. The cut-off point of the scale is 7 points and above.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Mini Nutritional Assessment (MNA)
    Description
    The Mini Nutritional Assessment (MNA) has recently been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min. In the test with a total score of 30, below 17 points is considered as significant malnutrition.
    Time Frame
    Change from baseline at 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    105 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being over the age of 65 Getting a diagnosis of sarcopenia To be able to walk at least 10 meters independently in public Getting a score of 4 and above from the clock drawing test Volunteer individuals Exclusion Criteria: Having a neurological disease Having an uncontrollable cardiopulmonary disease Acute illness that will prevent him/her from understanding and performing the exercises to be performed status or the presence of significant cognitive impairment Providing continuity for less than 80% of the exercise program

    12. IPD Sharing Statement

    Learn more about this trial

    Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia

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