Completed

NCT Number: NCT06823739

Personalized Diet and Physical Exercise in Malnourished Older Adults

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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

Primary outcomes

Improvement in Nutritional Status, Muscle Strength, Quality of Life and Physical Performance in Malnourished Older Adults

Time frame: 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 outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Feb 12, 2025
Registry last updated: Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed