Personalized Diet and Physical Exercise in Malnourished Older Adults

Not Applicable

Completed

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

• Registration Number: NCT06823739
• Lead Sponsor: Istanbul University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Malnourished old aged patients (≥65 years old) who were oriented, cooperated, and inde-pendent in daily living activities were included in the study

Exclusion Criteria

• Exclusion criteria were; <65 years of age, cognitive impairment, immobilization, eat-ing/swallowing disorders, receiving enteral or parenteral nutritional support, and having acute medical problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in Nutritional Status, Muscle Strength, Quality of Life and Physical Performance in Malnourished Older Adults	Baseline, 4th week, 8th week, and 12th week	The Mini Nutritional Assessment--Short Form (MNA-SF) test was performed . Body mass index (BMI) was calculated by body weight (kg) by square of the body height (m), and is expressed in kg/m2. The appendicular skeletal muscle mass (ASM) was measured through BIA using a Tanita MC 780 MA (Japan). The ASM index (ASMI) was calculated with by dividing the ASM by the square of the body height (kg/m2).; Muscle strength was measured using a standardized handheld dynamometer (Jamar, USA), the best of 3 measurements made the dominant hand.; A TUG test was performed to evaluate physical performance. The patients sat on a standard chair and were then told to get up from the chair, walk to a line 3 meters away, come back, and sit on the chair again.; The EuroQoL-5 Dimensions (EQ-5D) quality-of-life score and visual analog scale (EQ-5D VAS) were used to assess quality of life. The index score ranged from -0.59 to 1. -0.59 indicates a quality of life worse than death and 1 is a perfect life quality

Secondary Outcome Measures

Name	Time	Method
Correlation between the QoL score and Body Mass Index, Mını Nutritional Assessment Short Form, Hand Grip Strength, Appendiculer Muscle Mass Index, Timed up and Go	0th and 12th weeks	Correlation between the QoL score and other variables' changes are calculated after 12 weeks of intervention in the whole study group with Spearman correlations

Trial Locations

Locations (1)

Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey