NCT07418762

Community-Based Program Integrating Nurse-Led Mind-Body Exercise and Nutrition for Frailty

Community-Based Rehabilitation Integrating Nurse-Led Mind-Body Exercise and Nutritional Supplementation for Frailty: A Three-Arm Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Universitas Airlangga · Academic / Other
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to develop and evaluate a community-based rehabilitation program integrating nurse-led mind-body exercises and nutritional supplementation for frail older adults in Indonesia. This study uses a Randomized Controlled Trial (RCT) with three parallel groups and assessor blinding. The intervention was conducted for 8 weeks in community-dwelling older adults aged ≥ 65 years who live within the working area of a Community Health Center in Surabaya City. The sample size is 48 elderly. Participants will be divided into 3 groups: the control group, the Nurse-Led Mind-Body Exercise group, and the MBE + Nutritional Supplementation (MBE + Nutrition) group. The procedure is carried out after respondents provide voluntary consent. Confidentiality and anonymity of data will be strictly maintained throughout the research process. Data analysis between groups and within groups will be conducted using repeated-measures ANOVA and Intention-to-treat (ITT) analysis.

Detailed description

The sample was selected based on inclusion and exclusion criteria. Inclusion criteria were age ≥ 65 years, FRAIL scale score of 0 (robust), 1-3 (pre-frail), and 4-5 (frail), able to stand and walk independently without permanent aids, willing to participate in the 8-week program (three sessions per week), and provide written consent. Exclusion criteria included severe heart or respiratory conditions that would contraindicate exercise, moderate to severe cognitive impairment (MoCA-InaMSE \<18), recent stroke or severe musculoskeletal disorder, and known allergies or intolerances to protein supplements. 48 respondents were randomly assigned (stratified by gender and level of frailty) into one of three groups. Respondents who meet the criteria will be given a complete explanation of the research objectives, procedures, potential benefits, minimal risks, and the right to withdraw at any time without consequence. After understanding all this information, respondents will be asked to provide voluntary consent by signing an informed consent form. Once consent is granted, researchers will conduct direct data collection. In this study, subjects will undergo a series of research processes over several weeks. In week 1, direct data collection was conducted through physical examinations and measurements prior to the intervention. This process included measuring physical function using the Short Physical Performance Battery (SPPB) and the Time Up and Go Test (TUGT), measuring respiratory function using a peak flow meter, and examining body composition using Bioelectrical Impedance Analysis (BIA). In addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. addition, blood samples were taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. taken to analyze the levels of inflammatory biomarkers, namely Interleukin-6 (IL-6) and Tumor Necrosis Factor-α. Respondents in the control group in weeks 2, 3, and 4 will receive education about physical changes in the elderly, healthy lifestyle habits for healthy aging, and participate in integrated health service post (Posyandu) activities. In the following weeks, namely weeks 5, 6, 7, and 8, education will be provided about physical problems that occur in the elderly, activities carried out to prevent frailty, nutrition that helps prevent frailty, and participation in Posyandu activities. The implementation of education and Posyandu will be adjusted to the Posyandu schedule in the region. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on slow resistance, breath control, and relaxation. Exercises are carried out three times per week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): slow resistance training using resistance band tubing and balance and coordination exercises from Otago exercise, Cooling down (10 minutes): static stretching and breathing meditation with chair yoga. In the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro milk of 1.2 grams/kgBW/day during the 8-week intervention period, consumed daily after breakfast or after the exercise session. In addition, respondents will also receive an educational session on how to consume Ensure Gold Strength Pro milk. A sample of 16 participants per group was used as a reference because it is appropriate for detecting early trends in effectiveness in a community-based pilot study. Data analysis will include descriptive statistics related to the baseline characteristics of participants. Between-group and within-group comparisons will be conducted using mixed-effect models or repeated-measures ANOVA to assess changes over time and differences between intervention groups. Intention-to-treat (ITT) analysis will be applied to handle missing data, ensuring the reliability of the results. To control for potential type I error due to multiple comparisons, a Bonferroni correction will be applied. Statistical significance will be determined at a threshold of p \< 0.05. This study will be reviewed and approved by the Ethics Committee of the Faculty of Nursing, Airlangga University. All participants will receive a detailed explanation of the study procedures and provide written informed consent before participating. Data confidentiality and anonymity will be strictly maintained throughout the study. This study carries minimal risk to participants, as all activities are performed at a low intensity, and continuous monitoring will be conducted during each session to ensure participant safety.

Conditions

• Frail Elderly

Interventions

Type	Name	Description
BEHAVIORAL	Nurse-Led Mind-Body Exercise (MBE)	The study will be conducted for 8 weeks. Respondents in the mind-body exercise group will follow an exercise program aimed at improving muscle strength, balance, body composition, and respiratory function through gentle, integrated movements, focusing on gentle resistance, breath control, and relaxation. The exercises will be conducted three times a week for 8 weeks, with assistance at each session to ensure safety and correct technique. The program consists of three components: Warm-up (5 minutes): stretching the head, shoulders, hips, and knees, Main exercise (30 minutes): gentle resistance training using resistance band tubing and balance and coordination exercises from Otago exercise Cool-down (10 minutes): static stretching and breathing meditation with chair yoga. Meanwhile, in the combination group, respondents follow the entire mind-body exercise program as in the previous group and receive additional protein nutritional supplementation in the form of Ensure Gold Strength Pro

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-05-25
• Completion: 2026-05-25
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Indonesia