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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05705934
• Other study ID #: 2022-1268
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: November 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Exercise
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ondokuz Mayis University	Ankara Yildirim Beyazit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 12 weeks
Primary	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.	Change from baseline at 12 weeks
Primary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks