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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in Nutritional Status, Muscle Strength, Quality of Life and Physical Performance in Malnourished Older Adults
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malnourished old aged patients (≥65 years old) who were oriented, cooperated, and inde-pendent in daily living activities were included in the study
排除标准
- •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.
研究组 & 干预措施
personalized diet
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
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
干预措施: Exercise (Other)
结局指标
主要结局
Improvement in Nutritional Status, Muscle Strength, Quality of Life and Physical Performance in Malnourished Older Adults
时间窗: 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
次要结局
- 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)
研究者
Mustafa Altınkaynak
associate professor
Istanbul University