NCT06823739

Personalized Diet and Physical Exercise in Malnourished Older Adults

Personalized Diet with or Without Physical Exercise Improves Nutritional Status, Muscle Strength, Physical Performance and Quality of Life in Malnourished Older Adult Patients: a Prospec-tive Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

In this study, personalized diet therapy will be planned by expert dietitians for the volunteers, and they will be instructed on simple stretching and strengthening exercises they can perform independently at home. This instruction will also be supported visually. During the study, the body composition of the volunteers (muscle mass and percentage, fat mass and percentage) will be measured using a BIA device, and their height and weight will also be recorded. Hand grip strength will be measured using a device called a dynamometer. These measurements will be repeated monthly for a total of 3 months. To assess the quality of life of the volunteers, a questionnaire-based test will be conducted, and these measurements will also be repeated monthly for 3 months. Furthermore, the physical performance of the volunteers will be evaluated by having them stand up from a chair, walk 3 meters, return, and sit back down. This duration will be measured in seconds and recorded. These measurements will also be repeated monthly for 3 months. Volunteers have no obligations in this research. Since no invasive procedures (e.g., incisions, tissue or blood sampling, or use of medical devices to examine internal parts of the body) or medical drug therapies will be applied, the risks to the volunteers are minimal. By implementing personalized diets and standard physical exercise programs, it is anticipated that volunteers will receive medical benefits. Participation in the study is voluntary, and volunteers can refuse to participate or withdraw from the study at any time without facing any penalties or sanctions and without losing any rights. Observers, auditors, the ethics committee, institutions, and other relevant health authorities may have direct access to the medical records of the volunteers. However, this information will be kept confidential. By signing this informed consent form, the volunteer and their legal representative grant permission for such access. Records that reveal the identity of the volunteer will be kept confidential in accordance with relevant regulations, will not be disclosed to the public, and the identity of the volunteer will remain confidential even if the research results are published. If new information is obtained during the research that could affect the willingness of the volunteer to continue participating, the volunteer and their legal representative will be informed promptly. For information about the research, the volunteer's rights, or any adverse events related to the research, the volunteer can contact the individuals listed below 24/7 using the provided contact details. The anticipated duration for a volunteer to participate in this research is 3 months. No biological material will be obtained from volunteers in this research.

Conditions

• Malnourished Elderly
• Quality of Life (QOL)
• BMI
• Hand Grip Strength
• Timed Up and Go

Interventions

Type	Name	Description
OTHER	Exercise	This exercise program in PDE group was designed to be performed at home without re-quiring any specialized equipment. It aims to improve physical health, balance, and coor-dination while maintaining muscle strength and flexibility. Patients performed brist walking at least three times a week for a duration of 10 to 30 minutes per session. It also included balance practice and coordination exercises for 10 minutes. These include: Standing on tiptoes, balancing on one foot while holding onto a chair for support, walking in a straight line as if on a narrow beam. Finally, the exercise session ended with a 10-minute cool-down, focusing on relaxing muscles and performing gentle stretches to improve flexibility and reduce tension. All of the exercises were both explained and given in a figured chart, to the patients or the relatives

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-12-01
• Completion: 2020-12-31
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: Turkey (Türkiye)