Personalized Diet and Physical Exercise in Malnourished Older Adults

Istanbul University

Status: Completed

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

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06823739

228630-2021

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

personalized diet

No Intervention group

Description:

Participants in this group received an individualized nutritional intervention tailored to their energy and protein needs (25-30 kcal/kg/day and 1.0-1.2 g/kg/day, respectively). The diet plan included a balance of macronutrients (45-55% carbohydrates, 20-35% fats, and 20-30 g fiber daily) and emphasized protein diversity, whole grains, healthy fats, and adequate hydration. Weekly phone calls monitored adherence to the diet.

Personalized Diet with Physical Exercise

Active Comparator group

Description:

Participants in this group received the same personalized diet intervention as the PD group, but with the addition of a structured home-based physical exercise program. The program included: Warm-up (10 min): Stretching, posture exercises, and stationary marching Strength and balance training (20 min): Bodyweight exercises, balance drills, and brisk walking (10-30 min per session) Cool-down (10 min): Gentle stretching and relaxation

Treatment:

Other: Exercise